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Imbruvica Ibrutinib 70 mg/mL Suspension — NDC 57962-0007-12 package photo

Imbruvica Ibrutinib 70 mg/mL Suspension

by Pharmacyclics LLC · 1 BOTTLE, GLASS in 1 CARTON (57962-007-12) / 108 mL in 1 BOTTLE, GLASS
NDC 57962-0007-12
🏷️ FDA NDC (as labeled) 57962-007-12 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 57962-007-12
Product NDC 57962-007
11-digit billing NDC 57962000712
NCPDP billing unit ML — per mL (volume)
RxCUI 1442986, 1442992, 1994360, 1994362, 2000017, 2000019, 2000021, 2000023,
UNII 1X70OSD4VX
Application # NDA217003
SPL Set ID 0dfd0279-ff17-4ea9-89be-9803c71bab44
Established class (EPC) Kinase Inhibitor
Mechanism of action Protein Kinase Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-08-24
Route ORAL
Dosage form SUSPENSION
Substance IBRUTINIB
GPI-14 21532133001820
GCN Seq No 083770
GCN 52826
HICL code 040745
Ingredient (HICL) Ibrutinib
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1Q
Therapeutic class — specific (HIC3) Antineoplastic Systemic Enzyme Inhibitors
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name IMBRUVICA 70 MG/ML SUSPENSION
FDB brand name Imbruvica
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 57962-007-12 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 57962-0007-12. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) Bruton's tyrosine kinase (BTK) inhibitors
How it works Protein Kinase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerPharmacyclics LLC
Application holderPHARMACYCLICS LLC
FDA applicationNDA217003 (NDA)
Labeler code57962
First marketedAug 2022
Product typeHuman Prescription Drug
Portfolio6 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name IMBRUVICA 70 MG/ML SUSPENSION Ingredient Ibrutinib
📖 What it is MedlinePlus · NLM

Ibrutinib is used to treat adults with chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) and small lymphocytic lymphoma (SLL; a type of cancer that begins mostly in the lymph nodes). Ibrutinib is also used to treat adults with Waldenstrom's macroglobulinemia (WM; a slow-growing cancer that begins in certain white blood cells in your bone marrow). It is also used to treat adults and children 1 year of age with chronic graft vs host disease (cGVHD; a complication of hematopoietic stem-cell transplant [HSCT; a procedure that replaces diseased bone marrow wi...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Ibrutinib — sold as Imbruvica — is prescribed for certain blood cancers and for a serious immune complication that can happen after a bone marrow or stem cell transplant. For adult...
  • What exactly is ibrutinib used for, and why was I prescribed it?
  • You take ibrutinib by mouth once a day, at about the same time each day. Swallow the tablet or capsule whole with a full glass of water — don't crush, cut, break, or chew it. If yo...
  • How do I take this medicine, and does it matter if I take it with food?
📖 Read our full Ibrutinib guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color yellow / white / green / purple
ShapeOval
Imprintibr;420
Size18 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 22ADO53M6F
    A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $59.13 $6,386.14 / 108 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Imbruvica 70 mg/mLthis 57962-0007-12 Pharmacyclics 1 bottle — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2022
First FDA approval
Aug 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2039
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 24, 2022 RLD RS ⏳ ~12.7 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9795604 — method of use (U-3422)
US 10478439 — method of use (U-3422)
US 8563563 — method of use (U-3844)
US 8563563 — method of use (U-3843)
US 8563563 — method of use (U-3842)
US 8563563 — method of use (U-2666)
US 8563563 — method of use (U-3845)
US 8703780 — method of use (U-2666)
US 8703780 — method of use (U-3842)
US 8952015 — method of use (U-2666)
US 8952015 — method of use (U-3842)
US 8952015 — method of use (U-3843)
US 8952015 — method of use (U-3844)
US 8952015 — method of use (U-3845)
US 8999999 — method of use (U-2666)
US 8999999 — method of use (U-3842)
US 8999999 — method of use (U-3843)
US 8999999 — method of use (U-3844)
US 9125889 — method of use (U-3845)
US 9801881 — method of use (U-3846)
US 9801881 — method of use (U-3847)
US 9801883 — method of use (U-2666)
US 9801883 — method of use (U-3842)
US 9801883 — method of use (U-3843)
US 9801883 — method of use (U-3844)
US 10004746 — method of use (U-3846)
US 10004746 — method of use (U-3848)
US 10004746 — method of use (U-3849)
US 10004746 — method of use (U-3847)
US 10016435 — method of use (U-3845)
US 10463668 — method of use (U-2970)
US 10695350 — method of use (U-2970)
US 10751342 — method of use (U-2666)
US 10751342 — method of use (U-3844)
US 10751342 — method of use (U-3843)
US 10751342 — method of use (U-3842)
US 11672803 — method of use (U-2666)
US 11672803 — method of use (U-3842)
US 11672803 — method of use (U-3844)
US 11672803 — method of use (U-3843)
US 8476284 — method of use (U-3843)
US 8476284 — method of use (U-3844)
US 8476284 — method of use (U-3845)
US 8497277 — method of use (U-3422)
US 9795604 — method of use (U-2970)
US 8497277 — method of use (U-3842)
US 8497277 — method of use (U-3843)
US 8497277 — method of use (U-3845)
US 8497277 — method of use (U-3844)
US 8497277 — method of use (U-2666)
US 10478439 — method of use (U-3842)
US 10478439 — method of use (U-3844)
US 10478439 — method of use (U-2666)
US 10478439 — method of use (U-2970)
US 10478439 — method of use (U-3843)
US 10478439 — method of use (U-3845)
US 8497277 — method of use (U-2970)
US 8957079 — drug substance
US 8735403 — drug substance
US 10106548 — drug substance
US 9181257 — drug substance
US 8008309 — drug substance
US 9725455 — drug substance
US 8754091 — drug product
US 8697711 — drug substance
US 10125140 — drug substance
US 12364698 — drug product
US 10961251 — drug product
US 9296753 — drug substance
US 7514444 — drug substance
US 12201690 — drug product
US 8008309*PED — drug product
US 8697711*PED — drug product
US 8735403*PED — drug product
US 8497277*PED — drug product
US 7514444*PED — drug product
US 9296753*PED — drug product
US 8957079*PED — drug product
US 9181257*PED — drug product
US 8754091*PED — drug product
US 9725455*PED — drug product
US 9795604*PED — drug product
US 10106548*PED — drug product
US 10125140*PED — drug product
US 10961251*PED — drug product
US 10478439*PED — drug product
Exclusivity NP
Exclusivity ODE-405
Exclusivity PED
Exclusivity PED
2022 2024 2026 2028 2030 2032 2034 2036 2038
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (86)
PatentTypeUse codeExpires
US 9795604 ↗ Method of use U-3422 Oct 24, 2034
US 10478439 ↗ Method of use U-3422 Jun 3, 2031
US 8563563 ↗ Method of use U-3844 Apr 26, 2027
US 8563563 ↗ Method of use U-3843 Apr 26, 2027
US 8563563 ↗ Method of use U-3842 Apr 26, 2027
US 8563563 ↗ Method of use U-2666 Apr 26, 2027
US 8563563 ↗ Method of use U-3845 Apr 26, 2027
US 8703780 ↗ Method of use U-2666 Dec 28, 2026
US 8703780 ↗ Method of use U-3842 Dec 28, 2026
US 8952015 ↗ Method of use U-2666 Dec 28, 2026
US 8952015 ↗ Method of use U-3842 Dec 28, 2026
US 8952015 ↗ Method of use U-3843 Dec 28, 2026
US 8952015 ↗ Method of use U-3844 Dec 28, 2026
US 8952015 ↗ Method of use U-3845 Dec 28, 2026
US 8999999 ↗ Method of use U-2666 Jun 3, 2031
US 8999999 ↗ Method of use U-3842 Jun 3, 2031
US 8999999 ↗ Method of use U-3843 Jun 3, 2031
US 8999999 ↗ Method of use U-3844 Jun 3, 2031
US 9125889 ↗ Method of use U-3845 Jun 3, 2031
US 9801881 ↗ Method of use U-3846 Jun 3, 2031
US 9801881 ↗ Method of use U-3847 Jun 3, 2031
US 9801883 ↗ Method of use U-2666 Jun 3, 2031
US 9801883 ↗ Method of use U-3842 Jun 3, 2031
US 9801883 ↗ Method of use U-3843 Jun 3, 2031
US 9801883 ↗ Method of use U-3844 Jun 3, 2031
US 10004746 ↗ Method of use U-3846 Jun 3, 2031
US 10004746 ↗ Method of use U-3848 Jun 3, 2031
US 10004746 ↗ Method of use U-3849 Jun 3, 2031
US 10004746 ↗ Method of use U-3847 Jun 3, 2031
US 10016435 ↗ Method of use U-3845 Jun 3, 2031
US 10463668 ↗ Method of use U-2970 Oct 24, 2034
US 10695350 ↗ Method of use U-2970 Oct 24, 2034
US 10751342 ↗ Method of use U-2666 Jun 3, 2031
US 10751342 ↗ Method of use U-3844 Jun 3, 2031
US 10751342 ↗ Method of use U-3843 Jun 3, 2031
US 10751342 ↗ Method of use U-3842 Jun 3, 2031
US 11672803 ↗ Method of use U-2666 Jun 3, 2031
US 11672803 ↗ Method of use U-3842 Jun 3, 2031
US 11672803 ↗ Method of use U-3844 Jun 3, 2031
US 11672803 ↗ Method of use U-3843 Jun 3, 2031
US 8476284 ↗ Method of use U-3843 Dec 28, 2026
US 8476284 ↗ Method of use U-3844 Dec 28, 2026
US 8476284 ↗ Method of use U-3845 Dec 28, 2026
US 8497277 ↗ Method of use U-3422 Dec 28, 2026
US 9795604 ↗ Method of use U-2970 Oct 24, 2034
US 8497277 ↗ Method of use U-3842 Dec 28, 2026
US 8497277 ↗ Method of use U-3843 Dec 28, 2026
US 8497277 ↗ Method of use U-3845 Dec 28, 2026
US 8497277 ↗ Method of use U-3844 Dec 28, 2026
US 8497277 ↗ Method of use U-2666 Dec 28, 2026
US 10478439 ↗ Method of use U-3842 Jun 3, 2031
US 10478439 ↗ Method of use U-3844 Jun 3, 2031
US 10478439 ↗ Method of use U-2666 Jun 3, 2031
US 10478439 ↗ Method of use U-2970 Jun 3, 2031
US 10478439 ↗ Method of use U-3843 Jun 3, 2031
US 10478439 ↗ Method of use U-3845 Jun 3, 2031
US 8497277 ↗ Method of use U-2970 Dec 28, 2026
US 8957079 ↗ Drug substance — Dec 28, 2026
US 8735403 ↗ Drug substance — Dec 28, 2026
US 10106548 ↗ Drug substance — Jun 3, 2033
US 9181257 ↗ Drug substance — Dec 28, 2026
US 8008309 ↗ Drug substance — Nov 13, 2027
US 9725455 ↗ Drug substance — Jun 3, 2033
US 8754091 ↗ Drug product — Dec 28, 2026
US 8697711 ↗ Drug substance — Dec 28, 2026
US 10125140 ↗ Drug substance — Jun 3, 2033
US 12364698 ↗ Drug product — Apr 6, 2036
US 10961251 ↗ Drug product — Jun 3, 2033
US 9296753 ↗ Drug substance — Oct 30, 2033
US 7514444 ↗ Drug substance — Dec 28, 2026
US 12201690 ↗ Drug product — Jun 14, 2039
US 8008309*PED ↗ Drug product — May 13, 2028
US 8697711*PED ↗ Drug product — Jun 28, 2027
US 8735403*PED ↗ Drug product — Jun 28, 2027
US 8497277*PED ↗ Drug product — Jun 28, 2027
US 7514444*PED ↗ Drug product — Jun 28, 2027
US 9296753*PED ↗ Drug product — Apr 30, 2034
US 8957079*PED ↗ Drug product — Jun 28, 2027
US 9181257*PED ↗ Drug product — Jun 28, 2027
US 8754091*PED ↗ Drug product — Jun 28, 2027
US 9725455*PED ↗ Drug product — Dec 3, 2033
US 9795604*PED ↗ Drug product — Apr 24, 2035
US 10106548*PED ↗ Drug product — Dec 3, 2033
US 10125140*PED ↗ Drug product — Dec 3, 2033
US 10961251*PED ↗ Drug product — Dec 3, 2033
US 10478439*PED ↗ Drug product — Dec 3, 2031
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductAug 24, 2025
ODE-405Orphan Drug Exclusivity (7-year)Aug 24, 2029
PEDPediatric Exclusivity (+6 months)Feb 24, 2030
PEDPediatric Exclusivity (+6 months)Feb 24, 2026
Common questions
Is there a generic version of IMBRUVICA 70 MG/ML SUSPENSION?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for IMBRUVICA 70 MG/ML SUSPENSION. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jun 2039 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Imbruvica — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Imbruvica. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$309.08M
Claims incl. refills
32K
Beneficiaries
11.4K
Spend / beneficiary
$27,152.53
Spend / claim
$9,646.30
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Imbruvica (this brand).

Top reported reactions

Death8,579
Fatigue4,752
Diarrhoea4,191
Atrial Fibrillation3,894
Pneumonia3,263
Contusion2,820
Fall2,527

Reporter sex

80,310 reports
Male · 62%
Female · 38%
Unknown · 0%

Serious outcomes

Hospitalization26,719
Life-threatening1,939
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 13,527 1,474
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Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

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The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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Yes, they identify this exact package in different formats. The FDA registers it as 57962-007-12, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 57962-0007-12, written without dashes as 57962000712. The Identity section at the top of this page lists every form of this code.
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In 57962-0007-12, the first segment (57962) is the labeler code FDA assigned to Pharmacyclics LLC; the middle segment (0007) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) identifies this exact package size and type. Together they name one specific package of one specific product.
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📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 189 words ▾

1 INDICATIONS AND USAGE IMBRUVICA is a kinase inhibitor indicated for the treatment of: Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) ( 1.1 ). Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion ( 1.2 ). Adult patients with Waldenström’s macroglobulinemia (WM) ( 1.3 ).

Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy ( 1.4 ).

1.1Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). 1. 2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion.

1. 3 Waldenström’s Macroglobulinemia IMBRUVICA is indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). 1.

4 Chronic Graft versus Host Disease IMBRUVICA is indicated for the treatment of adult and pediatric patients age 1 year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION CLL/SLL and WM : 420 mg taken orally once daily ( 2.1 ). cGVHD : ◦ Patients 12 years and older: 420 mg taken orally once daily ( 2.1 ). ◦ Patients 1 to less than 12 years of age: 240 mg/m 2 taken orally once daily (up to a dose of 420 mg) ( 2.1 ). Tablets or capsules should be taken orally with a glass of water. Do not open, break, or chew the capsules.

Do not cut, crush, or chew the tablets. See full prescribing information for oral suspension administration instructions ( 2.1 ).

2.1Recommended Dosage Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Waldenström’s Macroglobulinemia The recommended dosage of IMBRUVICA for CLL/SLL and WM is 420 mg orally once daily until disease progression or unacceptable toxicity. For CLL/SLL, IMBRUVICA can be administered as a single agent, in combination with rituximab or obinutuzumab, or in combination with bendamustine and rituximab (BR). For WM, IMBRUVICA can be administered as a single agent or in combination with rituximab.

When administering IMBRUVICA in combination with rituximab or obinutuzumab, consider administering IMBRUVICA prior to rituximab or obinutuzumab when given on the same day. Chronic Graft versus Host Disease The recommended dosage of IMBRUVICA for patients age 12 years and older with cGVHD is 420 mg orally once daily, and for patients 1 to less than 12 years of age with cGVHD is 240 mg/m 2 orally once daily (up to a dose of 420 mg), until cGVHD progression, recurrence of an underlying malignancy, or unacceptable toxicity.

When a patient no longer requires therapy for the treatment of cGVHD, IMBRUVICA should be discontinued considering the medical assessment of the individual patient. Table 1: Recommended dosage based on body surface area (BSA) for patients 1 to less than 12 years of age using either IMBRUVICA capsules/tablets or oral suspension Recommended dose to achieve 240 mg/m 2 BSA* (m 2 ) Range Dose (mg) of IMBRUVICA Capsules/Tablets to Administer Volume (mL) of IMBRUVICA Oral Suspension (70 mg/mL) to Administer > 0.3 to 0.4 - 1.2 mL > 0.4 to 0.5 - 1.5 mL > 0.5 to 0.6 - 1.9 mL > 0.6 to 0.7 - 2.2 mL > 0.7 to 0.8 210 mg 2.6 mL > 0.8 to 0.9 210 mg 2.9 mL > 0.9 to 1 210 mg 3.3 mL > 1 to 1.1 280 mg 3.6 mL > 1.1 to 1.2 280 mg 4 mL > 1.2 to 1.3 280 mg 4.3 mL > 1.3 to 1.4 350 mg 4.6 mL > 1.4 to 1.5 350 mg 5 mL > 1.5 to 1.6 350 mg 5.3 mL > 1.6 420 mg 6 mL *BSA = body surface area.

Administration Administer IMBRUVICA at approximately the same time each day. Swallow tablets or capsules whole with a glass of water. Do not open, break, or chew the capsules.

Do not cut, crush, or chew the tablets. Follow Instructions for Use for further administration details of IMBRUVICA oral suspension. If a dose of IMBRUVICA is not taken at the scheduled time, it can be taken as soon as possible on the same day with a return to the normal schedule the following day.

Do not take extra doses of IMBRUVICA to make up for the missed dose.

2.2Dosage Modifications for Adverse Reactions For adverse reactions listed in Table 2 , interrupt IMBRUVICA therapy. Once the adverse reaction has improved to Grade 1 or baseline (recovery), follow the recommended dosage modifications (see Table 2 ). Table 2: Recommended Dosage Modifications for Adverse Reactions Adverse Reaction a,b Occurrence Dose Modification for CLL/SLL, WM, and Patients 12 Years or older with cGVHD After Recovery Starting Dose = 420 mg Dose Modification for Patients 1 Year to less than 12 Years with cGVHD After Recovery Starting Dose = 240 mg/m 2 Grade 2 cardiac failure First Restart at 280 mg daily c Restart at 160 mg/m 2 daily c Second Restart at 140 mg daily c Restart at 80 mg/m 2 daily c Third Discontinue IMBRUVICA Discontinue IMBRUVICA Grade 3 cardiac arrhythmias First Restart at 280 mg daily c Restart at 160 mg/m 2 daily c Second Discontinue IMBRUVICA Discontinue IMBRUVICA Grade 3 or 4 cardiac failure Grade 4 cardiac arrhythmias First Discontinue IMBRUVICA Discontinue IMBRUVICA Other Grade 3 o…

💊 Dosage Forms and Strengths 145 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsules: Each 70 mg capsule is a yellow, opaque capsule marked with “ibr 70 mg” in black ink. Each 140 mg capsule is a white, opaque capsule marked with “ibr 140 mg” in black ink. Tablets: Each 140 mg tablet is a yellow green to green round tablet debossed with “ibr” on one side and “140” on the other side.

Each 280 mg tablet is a purple oblong tablet debossed with “ibr” on one side and “280” on the other side. Each 420 mg tablet is a yellow green to green oblong tablet debossed with “ibr” on one side and “420” on the other side. Oral Suspension: 70 mg/mL, white to off-white suspension.

Capsules: 70 mg and 140 mg ( 3 ) Tablets: 140 mg, 280 mg, and 420 mg ( 3 ) Oral suspension: 70 mg/mL ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None None ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hemorrhage : Monitor for bleeding and manage ( 5.1 ). Infections : Monitor patients for fever and infections, evaluate promptly, and treat ( 5.2 ). Cardiac Arrhythmias , Cardiac Failure , and Sudden Death : Monitor for symptoms of arrhythmias and cardiac failure and manage ( 5.3 ).

Hypertension : Monitor blood pressure and treat ( 5.4 ). Cytopenias : Check complete blood counts monthly ( 5.5 ). Second Primary Malignancies : Other malignancies have occurred in patients, including skin cancers, and other carcinomas ( 5.6 ).

Hepatotoxicity, Including Drug- Induced Liver Injury : Monitor hepatic function throughout treatment ( 5.7 ). Tumor Lysis Syndrome (TLS) : Assess baseline risk and take precautions. Monitor and treat for TLS ( 5.8 ).

Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception ( 5.9 , 8.1 , 8.3 ).

5.1Hemorrhage Fatal bleeding events have occurred in patients who received IMBRUVICA. Major hemorrhage (≥ Grade 3, serious, or any central nervous system events; e.g., intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post procedural hemorrhage) occurred in 4.2% of patients, with fatalities occurring in 0.4% of 2,838 patients who received IMBRUVICA in 27 clinical trials. Bleeding events of any grade including bruising and petechiae occurred in 39%, and excluding bruising and petechiae occurred in 23% of patients who received IMBRUVICA, respectively [see Adverse Reactions ( 6.1 )] .

The mechanism for the bleeding events is not well understood. Use of either anticoagulant or antiplatelet agents concomitantly with IMBRUVICA increases the risk of major hemorrhage. Across clinical trials, 3.1% of 2,838 patients who received IMBRUVICA without antiplatelet or anticoagulant therapy experienced major hemorrhage.

The addition of antiplatelet therapy with or without anticoagulant therapy increased this percentage to 4.4%, and the addition of anticoagulant therapy with or without antiplatelet therapy increased this percentage to 6.1%. Consider the risks and benefits of anticoagulant or antiplatelet therapy when co-administered with IMBRUVICA. Monitor for signs and symptoms of bleeding.

Consider the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding [see Clinical Studies ( 14 )].

5.2Infections Fatal and non-fatal infections (including bacterial, viral, or fungal) have occurred with IMBRUVICA therapy. Grade 3 or greater infections occurred in 21% of 1,476 patients with B-cell malignancies who received IMBRUVICA in clinical trials [see Adverse Reactions ( 6.1 , 6.2 )] . Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA.

Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections. Monitor and evaluate patients for fever and infections and treat appropriately.

5.3Cardiac Arrhythmias, Cardiac Failure, and Sudden Death Fatal and serious cardiac arrhythmias and cardiac failure have occurred with IMBRUVICA. Deaths due to cardiac causes or sudden deaths occurred in 1% of 4,896 patients who received IMBRUVICA in clinical trials, including in patients who received IMBRUVICA in unapproved monotherapy or combination regimens. These adverse reactions occurred in patients with and without preexisting hypertension or cardiac comorbidities.

Patients with cardiac comorbidities may be at greater risk of these events. Grade 3 or greater ventricular tachyarrhythmias were reported in 0.2%, Grade 3 or greater atrial fibrillation and atrial flutter were reported in 3.7%, and Grade 3 or greater cardiac failure was reported in 1.3% of 4,896 patients who received IMBRUVICA in clinical trials, including in patients who received IMBRUVICA in…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hemorrhage [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Cardiac Arrhythmias, Cardiac Failure, and Sudden Death [see Warnings and Precautions ( 5.3 )] Hypertension [see Warnings and Precautions ( 5.4 )] Cytopenias [see Warnings and Precautions ( 5.5 )] Second Primary Malignancies [see Warnings and Precautions ( 5.6 )] Hepatotoxicity, including DILI [see Warning s and Precautions ( 5.7 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.8 )] The most common (≥30%) adverse reactions in patients with B-cell malignancies are thrombocytopenia, diarrhea, fatigue, musculoskeletal pain, neutropenia, rash, anemia, bruising, and nausea ( 6 ).

The most common (≥20%) adverse reactions in adult or pediatric patients with cGVHD are fatigue, anemia, bruising, diarrhea, thrombocytopenia, musculoskeletal pain, pyrexia, muscle spasms, stomatitis, hemorrhage, nausea, abdominal pain, pneumonia, and headache ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely variable conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with rates of clinical trials of another drug and may not reflect the rates observed in practice. Unless otherwise specified, the pooled safety population described in the WARNINGS AND PRECAUTIONS reflects exposure to IMBRUVICA in 6 trials. IMBRUVICA was administered as a single agent at 420 mg orally once daily (475 patients), as a single agent at 560 mg orally once daily [1.3 times the recommended adult dosage (174 patients)], and in combination with other drugs at 420 mg orally once daily (827 patients) in patients with B-cell malignancies.

In this pooled safety population of 1,476 patients, 87% were exposed for 6 months or longer and 68% were exposed for greater than one year. The most common adverse reactions (≥ 30%) were thrombocytopenia, diarrhea, fatigue, musculoskeletal pain, neutropenia, rash, anemia, bruising, and nausea. Certain subsections in the WARNINGS AND PRECAUTIONS include patients who received IMBRUVICA in unapproved monotherapy or combination regimens.

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma The data described below reflect exposure to IMBRUVICA in one single-arm, open-label clinical trial (Study 1102) and five randomized controlled clinical trials (RESONATE, RESONATE-2, HELIOS, iLLUMINATE, and E1912) in patients with CLL/SLL (n=2,016 total, including n=1,133 patients exposed to IMBRUVICA). In general, patients with creatinine clearance (CLcr) ≤ 30 mL/min, AST or ALT ≥ 2.5 x ULN, or total bilirubin ≥ 1.5 x ULN (unless of non-hepatic origin) were excluded from these trials.

In Study E1912, patients with AST or ALT > 3 x ULN or total bilirubin > 2.5 x ULN were excluded. Study 1102 included 51 patients with previously treated CLL/SLL. RESONATE included 386 randomized patients with previously treated CLL or SLL who received single agent IMBRUVICA or ofatumumab.

RESONATE-2 included 267 randomized patients with treatment naïve CLL or SLL who were 65 years or older and received single agent IMBRUVICA or chlorambucil. HELIOS included 574 randomized patients with previously treated CLL or SLL who received IMBRUVICA in combination with BR or placebo in combination with BR. iLLUMINATE included 228 randomized patients with treatment naïve CLL/SLL who were 65 years or older or with coexisting medical conditions and received IMBRUVICA in combination with obinutuzumab or chlorambucil in combination with obinutuzumab.

E1912 included 510 patients with previously untreated CLL/SLL who were 70 years or younger and received IMBRUVICA in combination with rituximab or received fludarabine, cyclophosphamide, and rituximab (FCR). The most common adverse…

🔄 Drug Interactions 173 words ▾

7 DRUG INTERACTIONS CYP3A Inhibitors: Modify IMBRUVICA dose as described ( 2.3 , 7.1 ). CYP3A Inducers: Avoid coadministration with strong CYP3A inducers ( 7.2 ).

7.1Effect of CYP3A Inhibitors on Ibrutinib The coadministration of IMBRUVICA with a strong or moderate CYP3A inhibitor may increase ibrutinib plasma concentrations [see Clinical Pharmacology ( 12.3 )] . Increased ibrutinib concentrations may increase the risk of drug-related toxicity. Dose modifications of IMBRUVICA are recommended when used concomitantly with posaconazole, voriconazole and moderate CYP3A inhibitors [see Dosage and Administration ( 2.3 )].

Avoid concomitant use of other strong CYP3A inhibitors. Interrupt IMBRUVICA if these inhibitors will be used short-term (such as anti-infectives for seven days or less) [see Dosage and Administration ( 2.3 ) ] . Avoid grapefruit and Seville oranges during IMBRUVICA treatment, as these contain strong or moderate inhibitors of CYP3A.

7.2Effect of CYP3A Inducers on Ibrutinib The coadministration of IMBRUVICA with strong CYP3A inducers may decrease ibrutinib concentrations. Avoid coadministration with strong CYP3A inducers [see Clinical Pharmacology ( 12.3 ) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed ( 8.2 ). Hepatic Impairment : Avoid use of IMBRUVICA in patients with severe hepatic impairment. In patients with mild or moderate impairment, reduce IMBRUVICA dose ( 2.4 , 8.6 ).

8.1Pregnancy Risk Summary IMBRUVICA can cause fetal harm based on findings from animal studies. There are no available data on IMBRUVICA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In animal reproduction studies, administration of ibrutinib to pregnant rats and rabbits during the period of organogenesis at exposures up to 3-20 times the clinical dose of 420 mg daily produced embryofetal toxicity including structural abnormalities (see Data) .

Advise pregnant women of the potential risk to a fetus. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Ibrutinib was administered orally to pregnant rats during the period of organogenesis at doses of 10, 40 and 80 mg/kg/day. Ibrutinib at a dose of 80 mg/kg/day was associated with visceral malformations (heart and major vessels) and increased resorptions and post-implantation loss.

The dose of 80 mg/kg/day in rats is approximately 20 times the exposure in patients with CLL/SLL or WM administered a dose of 420 mg daily. Ibrutinib at doses of 40 mg/kg/day or greater was associated with decreased fetal weights. The dose of 40 mg/kg/day in rats is approximately 8 times the exposure (AUC) in patients administered a dose of 420 mg daily.

Ibrutinib was also administered orally to pregnant rabbits during the period of organogenesis at doses of 5, 15, and 45 mg/kg/day. Ibrutinib at a dose of 15 mg/kg/day or greater was associated with skeletal variations (fused sternebrae) and ibrutinib at a dose of 45 mg/kg/day was associated with increased resorptions and post-implantation loss. The dose of 15 mg/kg/day in rabbits is approximately 2.8 times the exposure in patients with CLL/SLL or WM administered a dose of 420 mg daily.

8.2Lactation Risk Summary There is no information regarding the presence of ibrutinib or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with IMBRUVICA and for 1 week after the last dose.

8.3Females and Males of Reproductive Potential IMBRUVICA can cause fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1 )] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating IMBRUVICA. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with IMBRUVICA and for 1 month after the last dose.

Males Advise males with female partners of reproductive potential to use effective contraception during treatment with IMBRUVICA and for 1 month following the last dose.

8.4Pediatric Use Chronic GVHD The safety and effectiveness of IMBRUVICA have been established for treatment of cGVHD after failure of one or more lines of systemic therapy in pediatric patients 1 year of age and older. Use of IMBRUVICA for this indication is supported by evidence from iMAGINE, a study which included pediatric patients age 1 year and older with previously treated cGVHD, including patients in the following age groups: one patient 1 year to less than 2 years of age, 20 patients 2 years to less than 12 years of age, and 19 patients 12 years to less than 17 years of age.

Additional supportive efficacy data was provided from Study 1129 in adults [see Adverse Reactions ( 6.1 ), Clinical P…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary IMBRUVICA can cause fetal harm based on findings from animal studies. There are no available data on IMBRUVICA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In animal reproduction studies, administration of ibrutinib to pregnant rats and rabbits during the period of organogenesis at exposures up to 3-20 times the clinical dose of 420 mg daily produced embryofetal toxicity including structural abnormalities (see Data) .

Advise pregnant women of the potential risk to a fetus. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Ibrutinib was administered orally to pregnant rats during the period of organogenesis at doses of 10, 40 and 80 mg/kg/day. Ibrutinib at a dose of 80 mg/kg/day was associated with visceral malformations (heart and major vessels) and increased resorptions and post-implantation loss.

The dose of 80 mg/kg/day in rats is approximately 20 times the exposure in patients with CLL/SLL or WM administered a dose of 420 mg daily. Ibrutinib at doses of 40 mg/kg/day or greater was associated with decreased fetal weights. The dose of 40 mg/kg/day in rats is approximately 8 times the exposure (AUC) in patients administered a dose of 420 mg daily.

Ibrutinib was also administered orally to pregnant rabbits during the period of organogenesis at doses of 5, 15, and 45 mg/kg/day. Ibrutinib at a dose of 15 mg/kg/day or greater was associated with skeletal variations (fused sternebrae) and ibrutinib at a dose of 45 mg/kg/day was associated with increased resorptions and post-implantation loss. The dose of 15 mg/kg/day in rabbits is approximately 2.8 times the exposure in patients with CLL/SLL or WM administered a dose of 420 mg daily.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Chronic GVHD The safety and effectiveness of IMBRUVICA have been established for treatment of cGVHD after failure of one or more lines of systemic therapy in pediatric patients 1 year of age and older. Use of IMBRUVICA for this indication is supported by evidence from iMAGINE, a study which included pediatric patients age 1 year and older with previously treated cGVHD, including patients in the following age groups: one patient 1 year to less than 2 years of age, 20 patients 2 years to less than 12 years of age, and 19 patients 12 years to less than 17 years of age.

Additional supportive efficacy data was provided from Study 1129 in adults [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14.3 )] . The recommended dosage of IMBRUVICA in patients age 12 years and older is the same as that in adults, and the recommended dosage in patients age 1 year to less than 12 years old is based on body-surface area (BSA) [see Dosage and Administration ( 2.1 )] . The safety and effectiveness of IMBRUVICA have not been established for this indication in pediatric patients less than 1 year of age.

Mature B-cell Non-Hodgkin Lymphoma The safety and effectiveness of IMBRUVICA in combination with chemoimmunotherapy were assessed but have not been established based on an open-label, randomized study (NCT02703272) in 35 patients, which included 26 pediatric patients age 5 to less than 17 years, with previously treated mature B-cell non-Hodgkin lymphoma. The study was stopped for futility. In the randomized population, major hemorrhage and discontinuation of chemoimmunotherapy due to adverse reactions occurred more frequently in the ibrutinib plus chemoimmunotherapy arm compared to the chemoimmunotherapy alone arm.

CLL/SLL, CLL/SLL with 17p deletion, WM The safety and effectiveness of IMBRUVICA in pediatric patients have not been established in CLL/SLL, CLL/SLL with 17p deletion, or WM.

🧓 Geriatric Use 83 words ▾

8.5Geriatric Use Of 992 patients in clinical studies of IMBRUVICA for B-cell malignancies or cGVHD, 62% were ≥ 65 years of age, while 22% were ≥ 75 years of age [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] . No overall differences in effectiveness were observed between younger and older patients. Anemia (all grades), pneumonia (Grade 3 or higher), thrombocytopenia, hypertension, and atrial fibrillation occurred more frequently among older patients treated with IMBRUVICA [see Adverse Reactions ( 6.1 )] .

🆘 Overdosage 49 words ▾

10 OVERDOSAGE There is no specific experience in the management of ibrutinib overdose in patients. One healthy subject experienced reversible Grade 4 hepatic enzyme increases (AST and ALT) after a dose of 1680 mg. Closely monitor patients who ingest more than the recommended dosage and provide appropriate supportive treatment.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ibrutinib is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK). Ibrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways.

BTK’s role in signaling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis, and adhesion. Nonclinical studies show that ibrutinib inhibits malignant B-cell proliferation and survival in vivo as well as cell migration and substrate adhesion in vitro .

12.2Pharmacodynamics In patients with recurrent B-cell lymphoma > 90% occupancy of the BTK active site in peripheral blood mononuclear cells was observed up to 24 hours after ibrutinib doses of ≥ 2.5 mg/kg/day (≥ 175 mg/day for average weight of 70 kg). In adult patients with cGVHD, 93% occupancy of the BTK active site in peripheral blood mononuclear cells was observed at the ibrutinib recommended dose. The mean BTK occupancy in pediatric patients ranged from 95.1% to 99.6%.

In vitro Platelet Aggregation Ibrutinib demonstrated inhibition of collagen-induced platelet aggregation, with IC50 values at 4.6 µM (2026 ng/mL), 0.8 µM (352 ng/mL), and 3 µM (1321 ng/mL) in blood samples from healthy donors, donors taking warfarin, and donors with severe renal dysfunction, respectively. Ibrutinib did not show meaningful inhibition of platelet aggregation for ADP, arachidonic acid, ristocetin, and TRAP-6. Cardiac Electrophysiology At a single dose 4 times the maximum recommended dose (1680 mg), IMBRUVICA did not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics Ibrutinib exposure increases with doses up to 840 mg (2 times the maximum approved recommended dosage) in patients with B-cell malignancies. The mean steady-state AUC (% coefficient of variation) observed in patients at 420 mg with CLL/SLL is 708 (71%) ng×h/mL, with WM is 707 (72%) ng×h/mL, and in adult patients with previously treated cGVHD is 1159 (50%) ng×h/mL. Steady-state concentrations of ibrutinib without CYP3A inhibitors were achieved with an accumulation ratio of 1 to 1.6 after 1 week of multiple daily doses of 420 mg.

Absorption Absolute bioavailability of ibrutinib in fasted condition was 2.9% (90% CI: 2.1, 3.9) in healthy subjects. Ibrutinib is absorbed after oral administration with a median T max of 1 hour to 2 hours. Effect of Food The administration of IMBRUVICA with a high-fat and high-calorie meal (800 calories to 1,000 calories with approximately 50% of total caloric content of the meal from fat) increased ibrutinib C max by 2- to 4-fold and AUC by approximately 2-fold, compared with administration of ibrutinib after overnight fasting.

In vitro studies suggest that ibrutinib is not a substrate of p-glycoprotein (P-gp) or breast cancer resistance protein (BCRP). Distribution Reversible binding of ibrutinib to human plasma protein in vitro was 97.3% with no concentration dependence in the range of 50 ng/mL to 1000 ng/mL. The volume of distribution (V d ) was 683 L, and the apparent volume of distribution at steady state (V d,ss /F) was approximately 10,000 L.

Elimination Intravenous clearance was 62 L/h in fasted conditions and 76 L/h in fed conditions. In line with the high first-pass effect, the apparent oral clearance is 2000 L/h in fasted conditions and 1000 L/h in fed conditions. The half-life of ibrutinib is 4 hours to 6 hours.

Metabolism Metabolism is the main route of elimination for ibrutinib. It is metabolized to several metabolites primarily by cytochrome P450 (CYP) 3A and to a minor extent by CYP2D6. The active metabolite, PCI-45227, is a dihydrodiol metabolite with inhibitory activity towards BTK approximately 15 times lower than that of ibrutinib.

The range of the mean metabolite to parent ratio for PCI-45227 at steady-state is 1 to 2.8. Excretion Ibrutinib, mainly…

🧬 Mechanism of Action 95 words ▾

12.1Mechanism of Action Ibrutinib is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK). Ibrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways.

BTK’s role in signaling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis, and adhesion. Nonclinical studies show that ibrutinib inhibits malignant B-cell proliferation and survival in vivo as well as cell migration and substrate adhesion in vitro .

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Capsules The 70 mg capsules are supplied as yellow opaque capsules, marked with “ibr 70 mg” in black ink, in white HDPE bottles with a child-resistant closure: 28 capsules per bottle: NDC 57962-070-28 The 140 mg capsules are supplied as white opaque capsules, marked with “ibr 140 mg” in black ink, in white HDPE bottles with a child-resistant closure: 90 capsules per bottle: NDC 57962-140-09 120 capsules per bottle: NDC 57962-140-12 Store bottles at room temperature 20°C to 25°C (68°F to 77°F).

Brief exposure to 15°C to 30°C (59°F to 86°F) permitted (see USP Controlled Room Temperature). Retain in original package until dispensing. Tablets The IMBRUVICA (ibrutinib) tablets are supplied in 3 strengths in the following packaging configurations: 140 mg tablets: Yellow green to green round tablets debossed with “ibr” on one side and “140” on the other side.

Carton of one folded blister card containing two 14-count blister strips for a total of 28 tablets: NDC 57962-014-28 280 mg tablets: Purple oblong tablets debossed with “ibr” on one side and “280” on the other side. Carton of one folded blister card containing two 14-count blister strips for a total of 28 tablets: NDC 57962-280-28 420 mg tablets: Yellow green to green oblong tablets debossed with “ibr” on one side and “420” on the other side. Carton of one folded blister card containing two 14-count blister strips for a total of 28 tablets: NDC 57962-420-28 Store tablets in original packaging at room temperature 20°C to 25°C (68°F to 77°F).

Brief exposure to 15°C to 30°C (59°F to 86°F) permitted (see USP Controlled Room Temperature). Oral Suspension The IMBRUVICA (ibrutinib) oral suspension is a white to off-white suspension supplied as 108 mL in a 150 mL amber glass bottle with a pre-inserted bottle adapter and a child-resistant closure. Each mL contains 70 mg of ibrutinib.

The oral suspension bottle is provided in a carton with two 3 mL reusable oral dosing syringes: NDC 57962-007-12. Store the oral suspension bottle at 2°C to 25°C (36°F to 77°F). Do not freeze.

Dispense in original sealed container. Do not use if the carton seal is broken or missing. Discard any unused IMBRUVICA oral suspension remaining 60 days after first opening the bottle.

📋 Description ~1 min read ▾

11 DESCRIPTION Ibrutinib is a kinase inhibitor. It is a white to off-white solid with the empirical formula C 25 H 24 N 6 O 2 and a molecular weight 440.50. Ibrutinib is freely soluble in dimethyl sulfoxide, soluble in methanol and practically insoluble in water.

The chemical name for ibrutinib is 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one and has the following structure: IMBRUVICA (ibrutinib) is available as immediate-release oral capsules, immediate-release oral tablets, and immediate-release oral suspension. IMBRUVICA (ibrutinib) capsules for oral use are available in the following dosage strengths: 70 mg and 140 mg. Each capsule contains ibrutinib (active ingredient) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate.

The capsule shell contains gelatin, titanium dioxide, yellow iron oxide (70 mg capsule only), and black ink. IMBRUVICA (ibrutinib) tablets for oral use are available in the following dosage strengths: 140 mg, 280 mg, and 420 mg. Each tablet contains ibrutinib (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.

The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg and 420 mg tablets). IMBRUVICA (ibrutinib) oral suspension contains 70 mg/mL ibrutinib (active ingredient) and the following inactive ingredients: benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, purified water and sucralose.

The following structure for Ibrutinib is kinase inhibitor. It is a white to off-white solid with the empirical formula C25H24N6O2 and a molecular weight 440.50. Ibrutinib is freely soluble in dimethyl sulfoxide, soluble in methanol and practically insoluble in water.

The chemical name for ibrutinib is 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4 d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one and has

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patients and caregivers to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Hemorrhage: Inform patients of the possibility of bleeding, and to report any signs or symptoms (severe headache, blood in stools or urine, prolonged or uncontrolled bleeding). Inform the patient that IMBRUVICA may need to be interrupted for medical or dental procedures [see Warnings and Precautions ( 5.1 )] .

Infections: Inform patients of the possibility of serious infection, and to report any signs or symptoms (fever, chills, weakness, confusion) suggestive of infection [see Warnings and Precautions ( 5.2 )] . Cardiac arrhythmias , cardiac failure , and sudden death : Inform patients of the possibility of irregular heart rhythm, heart failure and sudden death. Counsel patients to report any signs of palpitations, lightheadedness, dizziness, fainting, shortness of breath, chest discomfort, or edema [see Warning s and Precautions ( 5.3 )] .

Hypertension : Inform patients that high blood pressure has occurred in patients taking IMBRUVICA, which may require treatment with anti-hypertensive therapy [see Warnings and Precautions ( 5.4 )] . Second primary malignancies: Inform patients that other malignancies have occurred in patients who have been treated with IMBRUVICA, including skin cancers and other carcinomas [see Warnings and Precautions ( 5.6 )] . Hepatotoxicity, including drug-induced liver injury: Inform patients that liver problems, including drug-induced liver injury and abnormalities in liver tests, may develop during IMBRUVICA treatment.

Advise patients to contact their healthcare provider immediately if they experience abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions ( 5.7 )]. Tumor lysis syndrome: Inform patients of the potential risk of tumor lysis syndrome and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions ( 5.8 )]. Embryo-fetal toxicity: Advise women of the potential risk to a fetus.

Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.9 ), Use in Specific Populations ( 8.1 )] . Advise females of reproductive potential to use effective contraception during treatment with IMBRUVICA and for 1 month after the last dose [see Use in Specific Populations ( 8.3 ) ] . Advise males with female partners of reproductive potential to use effective contraception during treatment with IMBRUVICA and for 1 month after the last dose [see Use in Specific Populations ( 8.3 ), Nonclinical Toxicology ( 13.1 )] .

Lactation: Advise women not to breastfeed during treatment with IMBRUVICA and for 1 week after the last dose [see Use in Specific Populations ( 8.2 )] . Other Important Information: Inform patients to take IMBRUVICA orally once daily according to their physician’s instructions and that the oral dosage (capsules or tablets) should be swallowed whole with a glass of water without opening, breaking or chewing the capsules or cutting, crushing or chewing the tablets approximately the same time each day [see Dosage and Administration ( 2.1 )] .

Advise patients that in the event of a missed daily dose of IMBRUVICA, it should be taken as soon as possible on the same day with a return to the normal schedule the following day. Patients should not take extra doses to make up the missed dose [see Dosage and Administration ( 2.1 )] . For IMBRUVICA oral suspension, instruct patients or caregivers to read and follow the Instructions for Use for proper preparation, administration, storage and disposal [see Dosage and Administration ( 2.1 )] .

Advise patients of the common side effects associated with IMBRUVICA [see Adverse Reactions ( 6 )] . Direct the patient to a complete list of adverse drug reactions in PATIENT INFORMATION . Advise patients to inform their health care provider…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.