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OGSIVEO nirogacestat 100 mg Tablet, Film Coated, 14-count — NDC 82448-0100-14 package photo

OGSIVEO nirogacestat 100 mg Tablet, Film Coated, 14-count

by SpringWorks Therapeutics, Inc. · 14 TABLET, FILM COATED in 1 BLISTER PACK (82448-100-14)
NDC 82448-0100-14
🏷️ FDA NDC (as labeled) 82448-100-14 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 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) 82448-100-14
Product NDC 82448-100
11-digit billing NDC 82448010014
NCPDP billing unit EA — each (per item)
RxCUI 2680360, 2680362, 2680363, 2680364, 2680366, 2680368, 2680369, 2680370
UNII QZ62892OFJ
Application # NDA217677
SPL Set ID f172e6ff-3190-41b0-b95a-58a7ef9e9e1e
Established class (EPC) Gamma Secretase Inhibitor
Mechanism of action Gamma Secretase Inhibitors; Cytochrome P450 3A Inhibitors; Cytochrome P450 2C19 Inducers
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-11-27
Route ORAL
Dosage form TABLET, FILM COATED
Substance NIROGACESTAT
GCN Seq No 085965
GCN 55579
HICL code 049323
Ingredient (HICL) Nirogacestat Hydrobromide
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 OGSIVEO 100 MG TABLET
FDB brand name Ogsiveo
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 82448-100-14 — 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 → 82448-0100-14. 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 Gamma Secretase Inhibitor class.

Pharmacologic class Gamma Secretase Inhibitor
Drug family (ATC) Other antineoplastic agents
How it works Cytochrome P450 2C19 Inducers, Cytochrome P450 3A Inhibitors, Gamma Secretase 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

LabelerSpringWorks Therapeutics, Inc.
Application holderSPRINGWORKS THERAPEUTICS INC
FDA applicationNDA217677 (NDA)
Labeler code82448
First marketedNov 2023
Product typeHuman Prescription Drug
Portfolio5 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 OGSIVEO 100 MG TABLET Ingredient Nirogacestat Hydrobromide
📖 What it is MedlinePlus · NLM

Nirogacestat is used to treat adults with desmoid tumors (a type of noncancerous tumors that occur most often in the stomach, arms, and legs). Nirogacestat is in a class of medications called gamma secretase inhibitors. It works by blocking the action of the abnormal protein that signals the tumors to grow. This helps to stop or slow tumor growth.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Desmoid tumors are rare, locally aggressive growths that form in connective tissue — things like the wall of your abdomen or around muscles. They're not typically cancerous in the...
  • What exactly is a desmoid tumor, and why does my doctor say I need this specific medication?
  • Honestly, it's something you need to prepare for — diarrhea was the most common side effect in clinical trials and affected the vast majority of patients who took Ogsiveo. For most...
  • I've heard diarrhea is a big issue with this medication. How bad is it really?
📖 Read our full Nirogacestat 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 orange
ShapeOval
Imprint150
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 H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII G7515SW10N
    A waxy liquid derived from vegetable oil and fatty acids. It works as an emulsifier and solubilizer to help blend oil and water-based ingredients together and improve how the medicine dissolves and is absorbed in the body.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $517.26 $7,241.62 / 14 tablets
Medicare drug plans payPart D · Q2 2026 $555.28 $7,773.85 / 14 tablets
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
Ogsiveo 100 mgthis 82448-0100-14 SpringWorks 14 tablets — — 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

🏛️
2024
First FDA approval
Apr 2024
📍
2026
Currently FDA-listed
2 years listed
🛡️
2043
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 May 2043. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 4, 2024 RLD RS ⏳ ~16.7 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 11807611 — method of use (U-3754)
US 11612588 — method of use (U-3754)
US 10941118 — drug substance (U-3754)
US 10710966 — drug substance (U-3754)
US 11845732 — drug substance (U-3754)
US 11844780 — method of use (U-3754)
US 12138246 — method of use (U-3754)
US 12138246 — method of use (U-3754)
US 12138246 — method of use (U-3754)
US 12011435 — method of use (U-3754)
US 12011435 — method of use (U-3754)
US 12011435 — method of use (U-3754)
US 12011434 — method of use (U-3754)
US 12011434 — method of use (U-3754)
US 12011434 — method of use (U-3754)
US 11925620 — method of use (U-3754)
US 11925619 — method of use (U-3754)
US 11938116 — method of use (U-3754)
US 11957662 — method of use (U-3754)
US 11957662 — method of use (U-3754)
US 11957662 — method of use (U-3754)
US 11951096 — method of use (U-3754)
US 11951096 — method of use (U-3754)
US 11951096 — method of use (U-3754)
US 11938116 — method of use (U-3754)
US 11938116 — method of use (U-3754)
US 11925620 — method of use (U-3754)
US 11925620 — method of use (U-3754)
US 11925619 — method of use (U-3754)
US 11925619 — method of use (U-3754)
US 12036207 — method of use (U-3754)
US 12036207 — method of use (U-3754)
US 12036207 — method of use (U-3754)
US 11872211 — method of use (U-3754)
US 11872211 — method of use (U-3754)
US 11872211 — method of use (U-3754)
US 11845732 — drug substance (U-3754)
US 11845732 — drug substance (U-3754)
US 11844780 — method of use (U-3754)
US 11844780 — method of use (U-3754)
US 11807611 — method of use (U-3754)
US 11807611 — method of use (U-3754)
US 11612588 — method of use (U-3754)
US 11612588 — method of use (U-3754)
US 10941118 — drug substance (U-3754)
US 10941118 — drug substance (U-3754)
US 10710966 — drug substance (U-3754)
US 10710966 — drug substance (U-3754)
US 12247012 — drug product
US 11884635 — drug product
US 11884635 — drug product
US 11820748 — drug product
US 7795447 — drug substance
US 12110277 — drug product
US 11820748 — drug product
US 11504354 — drug product
US 12247012 — drug product
US 7795447 — drug substance
US 12599587 — drug product
US 11905255 — drug product
US 12116347 — drug product
US 12234210 — drug product
US 11884635 — drug product
US 11884634 — drug product
US 11905255 — drug product
US 12234210 — drug product
US 11884634 — drug product
US 11905255 — drug product
US 11884634 — drug product
US 12599587 — drug product
US 7795447 — drug substance
US 12599587 — drug product
US 12297177 — drug product
US 10590087 — drug substance
US 12110277 — drug product
US 11820748 — drug product
US 12247012 — drug product
US 12116347 — drug product
US 10590087 — drug substance
US 12234210 — drug product
US 11504354 — drug product
US 12297177 — drug product
US 10590087 — drug substance
US 12116347 — drug product
US 11504354 — drug product
US 12110277 — drug product
US 12297177 — drug product
Exclusivity NCE
Exclusivity ODE-452
Exclusivity NCE
Exclusivity ODE*
Exclusivity NCE
Exclusivity ODE*
2024 2026 2028 2030 2032 2034 2036 2038 2040 2042
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 (87)
PatentTypeUse codeExpires
US 11807611 ↗ Method of use U-3754 Sep 8, 2042
US 11612588 ↗ Method of use U-3754 Jul 8, 2042
US 10941118 ↗ Drug substance U-3754 Aug 9, 2039
US 10710966 ↗ Drug substance U-3754 Aug 9, 2039
US 11845732 ↗ Drug substance U-3754 Aug 9, 2039
US 11844780 ↗ Method of use U-3754 Sep 8, 2042
US 12138246 ↗ Method of use U-3754 May 19, 2043
US 12138246 ↗ Method of use U-3754 May 19, 2043
US 12138246 ↗ Method of use U-3754 May 19, 2043
US 12011435 ↗ Method of use U-3754 May 19, 2043
US 12011435 ↗ Method of use U-3754 May 19, 2043
US 12011435 ↗ Method of use U-3754 May 19, 2043
US 12011434 ↗ Method of use U-3754 May 19, 2043
US 12011434 ↗ Method of use U-3754 May 19, 2043
US 12011434 ↗ Method of use U-3754 May 19, 2043
US 11925620 ↗ Method of use U-3754 May 19, 2043
US 11925619 ↗ Method of use U-3754 May 19, 2043
US 11938116 ↗ Method of use U-3754 May 19, 2043
US 11957662 ↗ Method of use U-3754 May 19, 2043
US 11957662 ↗ Method of use U-3754 May 19, 2043
US 11957662 ↗ Method of use U-3754 May 19, 2043
US 11951096 ↗ Method of use U-3754 May 19, 2043
US 11951096 ↗ Method of use U-3754 May 19, 2043
US 11951096 ↗ Method of use U-3754 May 19, 2043
US 11938116 ↗ Method of use U-3754 May 19, 2043
US 11938116 ↗ Method of use U-3754 May 19, 2043
US 11925620 ↗ Method of use U-3754 May 19, 2043
US 11925620 ↗ Method of use U-3754 May 19, 2043
US 11925619 ↗ Method of use U-3754 May 19, 2043
US 11925619 ↗ Method of use U-3754 May 19, 2043
US 12036207 ↗ Method of use U-3754 May 19, 2043
US 12036207 ↗ Method of use U-3754 May 19, 2043
US 12036207 ↗ Method of use U-3754 May 19, 2043
US 11872211 ↗ Method of use U-3754 May 19, 2043
US 11872211 ↗ Method of use U-3754 May 19, 2043
US 11872211 ↗ Method of use U-3754 May 19, 2043
US 11845732 ↗ Drug substance U-3754 Aug 9, 2039
US 11845732 ↗ Drug substance U-3754 Aug 9, 2039
US 11844780 ↗ Method of use U-3754 Sep 8, 2042
US 11844780 ↗ Method of use U-3754 Sep 8, 2042
US 11807611 ↗ Method of use U-3754 Sep 8, 2042
US 11807611 ↗ Method of use U-3754 Sep 8, 2042
US 11612588 ↗ Method of use U-3754 Jul 8, 2042
US 11612588 ↗ Method of use U-3754 Jul 8, 2042
US 10941118 ↗ Drug substance U-3754 Aug 9, 2039
US 10941118 ↗ Drug substance U-3754 Aug 9, 2039
US 10710966 ↗ Drug substance U-3754 Aug 9, 2039
US 10710966 ↗ Drug substance U-3754 Aug 9, 2039
US 12247012 ↗ Drug product — Jul 8, 2042
US 11884635 ↗ Drug product — Aug 9, 2039
US 11884635 ↗ Drug product — Aug 9, 2039
US 11820748 ↗ Drug product — Aug 9, 2039
US 7795447 ↗ Drug substance — Aug 18, 2030
US 12110277 ↗ Drug product — Jul 8, 2042
US 11820748 ↗ Drug product — Aug 9, 2039
US 11504354 ↗ Drug product — Jul 8, 2042
US 12247012 ↗ Drug product — Jul 8, 2042
US 7795447 ↗ Drug substance — Aug 18, 2030
US 12599587 ↗ Drug product — Jul 8, 2042
US 11905255 ↗ Drug product — Aug 9, 2039
US 12116347 ↗ Drug product — Aug 9, 2039
US 12234210 ↗ Drug product — Jul 8, 2042
US 11884635 ↗ Drug product — Aug 9, 2039
US 11884634 ↗ Drug product — Aug 9, 2039
US 11905255 ↗ Drug product — Aug 9, 2039
US 12234210 ↗ Drug product — Jul 8, 2042
US 11884634 ↗ Drug product — Aug 9, 2039
US 11905255 ↗ Drug product — Aug 9, 2039
US 11884634 ↗ Drug product — Aug 9, 2039
US 12599587 ↗ Drug product — Jul 8, 2042
US 7795447 ↗ Drug substance — Aug 18, 2030
US 12599587 ↗ Drug product — Jul 8, 2042
US 12297177 ↗ Drug product — Aug 9, 2039
US 10590087 ↗ Drug substance — Aug 9, 2039
US 12110277 ↗ Drug product — Jul 8, 2042
US 11820748 ↗ Drug product — Aug 9, 2039
US 12247012 ↗ Drug product — Jul 8, 2042
US 12116347 ↗ Drug product — Aug 9, 2039
US 10590087 ↗ Drug substance — Aug 9, 2039
US 12234210 ↗ Drug product — Jul 8, 2042
US 11504354 ↗ Drug product — Jul 8, 2042
US 12297177 ↗ Drug product — Aug 9, 2039
US 10590087 ↗ Drug substance — Aug 9, 2039
US 12116347 ↗ Drug product — Aug 9, 2039
US 11504354 ↗ Drug product — Jul 8, 2042
US 12110277 ↗ Drug product — Jul 8, 2042
US 12297177 ↗ Drug product — Aug 9, 2039
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Nov 27, 2028
ODE-452Orphan Drug Exclusivity (7-year)Nov 27, 2030
NCENew Chemical Entity (5-year)Nov 27, 2028
ODE*Orphan Drug Exclusivity (7-year)Nov 27, 2030
NCENew Chemical Entity (5-year)Nov 27, 2028
ODE*Orphan Drug Exclusivity (7-year)Nov 27, 2030
Common questions
Is there a generic version of OGSIVEO 100 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for OGSIVEO 100 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until May 2043 — 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 82448-0100-14, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
57
Units reimbursed last 4 qtrs
2.9K
Gross reimbursed last 4 qtrs
$1.52M
Avg / prescription
$26,679.65
Avg / unit
$517.26
Latest quarter Q4 2025
16Rx
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 57 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 560 units · 9.5 per 100k residents WI Michigan: no data reported MI New York: 644 units · 3.3 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 1,736 units · 4.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.39.5
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Wisconsin 9.5 /100k
2 California 4.5 /100k
3 New York 3.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Ogsiveo — 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 Ogsiveo. 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
$10.33M
Claims incl. refills
366
Beneficiaries
157
Spend / beneficiary
$65,812.21
Spend / claim
$28,230.92
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 OGSIVEO (this brand).

Top reported reactions

Diarrhoea305
Nausea193
Fatigue163
Rash109
Headache87
Vomiting75
Stomatitis59

Age at onset

Child3
Adolescent2
Adult56
Elderly8

Reporter sex

838 reports
Male · 34%
Female · 66%

Serious outcomes

Hospitalization113
Disabling11
Life-threatening8
Death8
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 563 15
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
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

Package NDCDescription Marketing startStatus
82448-0100-14 You're viewing this 14 TABLET, FILM COATED in 1 BLISTER PACK (82448-100-14) 2023-11-27 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
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.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 82448-100-14, 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: 82448-0100-14, written without dashes as 82448010014. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 82448-0100-14, the first segment (82448) is the labeler code FDA assigned to SpringWorks Therapeutics, Inc.; the middle segment (0100) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (14) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by SpringWorks Therapeutics, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SpringWorks Therapeutics, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 39 words ▾

1 INDICATIONS AND USAGE OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment. OGSIVEO is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage is 150 mg orally twice daily until disease progression or unacceptable toxicity. ( 2.1 ) See Full Prescribing Information for dosage modifications due to adverse reactions. ( 2.2 )

2.1Recommended Dosage The recommended dosage of OGSIVEO is 150 mg administered orally twice daily until disease progression or unacceptable toxicity. OGSIVEO may be taken with or without food. Instruct patients to swallow OGSIVEO tablets whole and not to break, crush, or chew prior to swallowing. If a patient vomits or misses a dose, instruct the patient to take the next dose at its scheduled time.

2.2Dos ag e Modifications for Adverse Reactions The recommended dose modifications for OGSIVEO for selected severe adverse reactions are summarized in Table 1 [ see Warnings and Precautions ( 5 ) , Adverse Reactions ( 6 ) ]. For other severe adverse reactions, life-threatening adverse reactions, or persistent intolerable Grade 2 adverse reactions, withhold drug until resolved to Grade ≤ 1 or baseline. Only restart at a dosage of 100 mg twice daily after considering the potential benefit and likelihood of recurrence of the adverse reaction.

Permanently discontinue OGSIVEO for recurrence of severe or life-threatening adverse reaction upon rechallenge at the reduced dose. Table 1. Recommended Dose Modifications for Adverse Reactions Adverse Reaction Severity OGSIVEO Dosage Modifications Diarrhea persisting for ≥ 3 days despite maximal medical therapy [ see Warnings and Precautions ( 5.1 ) ] Grades 3 or 4 Withhold OGSIVEO until resolved to Grade ≤ 1 or baseline, then restart at a dosage of 100 mg twice daily.

Increased ALT or AST [see Warnings and Precautions ( 5.3 ) ] Grade 2 (≥ 3 to 5 × ULN) Withhold OGSIVEO until ALT, AST, or both are resolved to < 3 × ULN or baseline, then restart at a dosage of 100 mg twice daily. Grades 3 or 4 (> 5 × ULN) Permanently discontinue. Hypophosphatemia persisting for ≥ 3 days despite maximal replacement therapy [see Warnings and Precautions ( 5.5 ) ] Grades 3 or 4 Withhold OGSIVEO until resolved to Grade ≤ 1 or baseline, then restart at a dosage of 100 mg twice daily.

Hypokalemia despite maximal replacement therapy [see Warnings and Precautions ( 5.5 ) ] Grades 3 or 4 Withhold OGSIVEO until resolved to Grade ≤ 1 or baseline, then restart at a dosage of 100 mg twice daily. Anaphylaxis or other severe hypersensitivity reaction [see Warnings and Precautions (5.6) ] Grades 3 or 4 Permanently discontinue.

💊 Dosage Forms and Strengths 62 words ▾

3 DOSAGE FORMS AND STRENGTHS The 100 mg tablets are round, light orange, film-coated, and debossed with "100" on one face. Each 100 mg tablet contains 100 mg nirogacestat. The 150 mg tablets are oval, yellow orange, film-coated, and debossed with "150" on one face. Each 150 mg tablet contains 150 mg nirogacestat. Tablets: 100 mg, and 150 mg. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Diarrhea : Severe diarrhea can occur. Monitor and dose modify for Grade 3-4 diarrhea. ( 5.1 ) Ovarian Toxicity : Female reproductive function and fertility may be impaired.

Advise females of reproductive potential of the potential risk prior to treatment and monitor routinely. ( 5.2 ) Hepatotoxicity : Elevated AST and ALT can occur. Monitor AST and ALT regularly and modify dose as recommended.

( 5.3 ) Non-Melanoma Skin Cancers : Perform dermatologic examination prior to initiation of OGSIVEO and routinely during treatment. ( 5.4 ) Electrolyte Abnormalities : Monitor phosphate and potassium regularly and modify dose as recommended. ( 5.5 ) Hypersensitivity Reactions : Monitor for signs and symptoms of hypersensitivity; interrupt or permanently discontinue OGSIVEO based on severity.

( 2.2 , 5.6 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.7 , 8.1 , 8.3 )

5.1Diarrhea Diarrhea, sometimes severe, can occur in patients treated with OGSIVEO [see Adverse Reactions ( 6.1 ) ] . In DeFi, diarrhea occurred in 84% of patients treated with OGSIVEO, and included Grade 3 events in 16% of patients. Median time to first diarrhea event for patients treated with OGSIVEO was 9 days (range: 2 to 434 days).

Monitor patients and manage using antidiarrheal medications. Modify dose as recommended [ see Dosage and Administration ( 2.2 ) ]. 5.

2 Ovarian Toxicity Female reproductive function and fertility may be impaired in patients being treated with OGSIVEO. Impact on fertility may depend on factors including the duration of therapy and the state of gonadal function at the time of treatment. The long-term effects of OGSIVEO on fertility have not been established.

Advise patients on the potential risks for ovarian toxicity before initiating treatment with OGSIVEO [ see Use in Specific Populations ( 8.3 ) ]. Monitor patients for changes in menstrual cycle regularity or the development of symptoms of estrogen deficiency, including hot flashes, night sweats, and vaginal dryness. 5.

3 Hepatotoxicity ALT or AST elevations occurred in 30% and 33% of patients who received OGSIVEO in DeFi, respectively. Grade 3 ALT or AST elevations (> 5 × ULN) occurred in 6% and 2.9% of patients, respectively [see Adverse Reactions ( 6.1 ) ] . Monitor liver function tests regularly and modify dose as recommended [see Dosage and Administration ( 2.2 ) ] .

5. 4 Non-Melanoma Skin Cancers New non-melanoma skin cancers can occur in patients treated with OGSIVEO. In DeFi, cutaneous squamous cell carcinoma and basal cell carcinoma occurred in 2.9% and 1.4% of patients, respectively [see Adverse Reactions ( 6.1 ) ].

Perform dermatologic evaluations prior to initiation of OGSIVEO and routinely during treatment. 5. 5 Electrolyte Abnormalities Electrolyte abnormalities can occur in patients treated with OGSIVEO.

In DeFi, these included decreased phosphate (65%) and decreased potassium (22%). Phosphate <2 mg/dL occurred in 20% of patients who received OGSIVEO. Grade 3 decreased potassium occurred in 1.4% of patients [ see A dverse Reactions ( 6.1 ) ] .

Monitor phosphate and potassium levels regularly and supplement as necessary. Modify dose as recommended [see Dosage and Administration ( 2.2 ) ].

5.6Hypersensitivity Reactions Hypersensitivity reactions, including severe hypersensitivity reactions, have been reported with postmarketing use of OGSIVEO. Monitor patients for signs and symptoms of hypersensitivity during treatment with OGSIVEO and manage as clinically indicated. Interrupt dosing or permanently discontinue OGSIVEO depending on the severity [see Dosage and Administration (2.2) ].

5. 7 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, OGSIVEO can cause fetal harm when administered to pregnant women. Oral administration of nirogacestat to pregnant rats during the period of organogenesis resulted in…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Diarrhea [ see Warnings and Precautions ( 5.1 )] Ovarian Toxicity [ see Warnings and Precautions ( 5.2 )] Hepatotoxicity [see Warnings and Precautions ( 5.3 )] Non-Melanoma Skin Cancers [see Warnings and Precautions ( 5.4 )] Electrolyte Abnormalities [ see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions (5.6) ] The most common ( > 15 %) adverse reactions are diarrhea, ovarian toxicity, rash, nausea, fatigue, stomatitis, headache, abdominal pain, cough, alopecia, upper respiratory tract infection and dyspnea.

( 6.1 ) The most common laboratory abnormalities (≥15%) are decreased phosphate, increased urine glucose, increased urine protein, increased AST, increased ALT, and decreased potassium. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact SpringWorks Therapeutics Inc. at 1-888-400-7989 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of OGSIVEO was evaluated in 69 patients enrolled in DeFi with progressing desmoid tumor [see Clinical Studies ( 14 ) ]. Patients received OGSIVEO 150 mg orally twice daily or placebo orally twice daily until disease progression or unacceptable toxicity.

The median duration of exposure to OGSIVEO was 20.6 months (range: 0.3 to 33.6). Serious adverse reactions occurred in 20% of patients who received OGSIVEO. Serious adverse reactions occurring in ≥ 2% of patients were ovarian toxicity (4%).

Permanent discontinuation of OGSIVEO due to an adverse reaction occurred in 20% of patients. Adverse reactions which resulted in permanent discontinuation of OGSIVEO in ≥ 2% of patients were diarrhea, ovarian toxicity, increased ALT, and increased AST. Dosage interruptions of OGSIVEO due to an adverse reaction occurred in 51% of patients.

Adverse reactions which required dosage interruption in ≥ 2% of patients included diarrhea, rash, stomatitis, hypophosphatemia, fatigue, folliculitis, nausea, and ovarian toxicity. Dose reductions of OGSIVEO due to an adverse reaction occurred in 42% of patients. Adverse reactions which required dose reductions in ≥ 2% of patients included diarrhea, rash, stomatitis, hypophosphatemia, folliculitis, hidradenitis, and ovarian toxicity.

The most common (≥ 15% with a difference between arms of ≥ 5% compared to placebo) adverse reactions that occurred in patients receiving OGSIVEO were diarrhea, ovarian toxicity, rash, nausea, fatigue, stomatitis, headache, abdominal pain, cough, alopecia, upper respiratory tract infection and dyspnea. Table 2 summarizes the adverse reactions that occurred in DeFi. Table 2.

Adverse Reactions (≥ 15%) in Patients with Desmoid Tumor Who Received OGSIVEO with a Difference Between Arms of ≥ 5% Compared to Placebo on DeFi Adverse Reaction OGSIVEO (N = 69) Placebo (N = 72) All Grades (%) Grade 3 (%) All Grades (%) Grade 3 (%) Gastrointestinal Diarrhea 84 16 35

1.4Nausea 54 1.4 39 0 Stomatitis a 39 4 4 0 Abdominal pain a 22 1.4 14

1.4Reproductive S ystem Ovarian toxicity a , b 75 c 0 0 0 Skin and S ubcutaneous T issue Rash a 68 6 14 0 Alopecia 19 0 1.4 0 General Fatigue a 54 2.9 38 0 Nervous S ystem Headache a 30 0 15 0 Respiratory Cough a 20 0 6 0 Dyspnea 16 0 6 0 Infections Upper respiratory tract 17 0 2.8 0 infection a a Includes multiple related composite terms. b Investigator assessment of ovarian toxicity included ovarian failure, premature menopause, amenorrhea, and menopause c The number of females of reproductive potential in each arm is used as the denominator (OGSIVEO N = 36, Placebo N = 37) Clinically relevant adverse reactions occurring in < 15% of patients receiving OGSIVEO in DeFi included no…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Strong or moderate CYP3A inhibitors : Avoid concomitant use. ( 7.1 ) Strong or moderate CYP3A inducers : Avoid concomitant use. ( 7.1 ) Gastric acid reducing agents : Avoid concomitant use with proton pump inhibitors and H2-receptor antagonists. If concomitant use cannot be avoided, OGSIVEO administration can be staggered with antacids. ( 7.1 )

7.1Effect s of Other Drugs on OGSIVEO Table 4. Effects of Other Drugs on OGSIVEO Strong or Moderate CYP3A Inhibitors Prevention or Management Avoid concomitant use of OGSIVEO with strong or moderate CYP3A inhibitors including grapefruit products, Seville oranges, and starfruit. Clinical Effect Nirogacestat is a CYP3A substrate.

Strong or moderate CYP3A inhibitors increase nirogacestat exposure [see Clinical Pharmacology ( 12.3 ) ], which may increase the risk of OGSIVEO adverse reactions . Strong or Moderate CYP3A Inducers Prevention or Management Avoid concomitant use of OGSIVEO with strong or moderate CYP3A inducers. Clinical Effect Nirogacestat is a CYP3A substrate.

Strong or moderate CYP3A inducers decrease serum nirogacestat exposure [ see Clinical Pharmacology ( 12.3 ) ], which may reduce the effectiveness of OGSIVEO. Gastric Acid Reducing Agents Prevention or Management Avoid concomitant use with proton pump inhibitors and H2 blockers . If concomitant use cannot be avoided, OGSIVEO can be staggered with antacids (e.g., administer OGSIVEO 2 hours before or 2 hours after antacid use).

Clinical Effect Nirogacestat is poorly soluble at pH ≥ 6. Gastric acid reducing agents may decrease serum nirogacestat exposure [ see Clinical Pharmacology ( 12.3 ) ], which may reduce the effectiveness of OGSIVEO.

7.2Effects of OGSIVEO on Other Drugs Table 5. Effects of OGSIVEO on Other Drugs Certain CYP3ASubstrates Prevention or Management Avoid concomitant use with CYP3A substrates where minimal concentration changes may lead to serious adverse reactions . Clinical Effect Nirogacestat increases exposure of CYP3A substrates [see Clinical Pharmacology ( 12.3 ) ], which may increase the risk of adverse reactions related to these substrates.

Certain CYP2C19 Substrates Prevention or Management Avoid concomitant use with OGSIVEO where decreased concentrations of CYP2C19 substrates may lead to significant decreases in efficacy of the CYP2C19 substrate unless otherwise recommended in the Prescribing Information for the CYP2C19 substrate. Clinical Effect Nirogacestat decreases exposure of CYP2C19 substrates [see Clinical Pharmacology ( 12.3 ) ], which may decrease efficacy of these substrates.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, OGSIVEO can cause fetal harm or loss of pregnancy when administered to a pregnant woman [ see C linical Pharmacology ( 12.1 ) ] . Oral administration of nirogacestat to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity and embryo-fetal death at maternal exposures below the human exposure at the recommended dose of 150 mg twice daily [see Data ] . There are no available data on the use of OGSIVEO in pregnant women.

Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Daily oral administration of nirogacestat to pregnant rats during the period of organogenesis resulted in decreased fetal body weights, pre- and post-implantation loss, and fetal subcutis edema at doses ≥ 20 mg/kg/day (approximately 0.85 times the recommended dose of 150 mg twice daily based on area under the curve).

8.2Lactation Risk Summary There are no data on the presence of nirogacestat or its metabolites in human milk or the effects of nirogacestat on a breastfed child or milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with OGSIVEO and for 1 week after the last dose.

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

OGSIVEO can affect ovarian function and the development of the ovarian follicle and therefore may reduce the effectiveness of hormonal contraceptives. Addition of a barrier method is recommended for females using hormonal contraceptives. Males Advise males with female partners of reproductive potential to use effective contraception during treatment with OGSIVEO and for 1 week after the last dose.

Infertility Based on findings in animal studies, OGSIVEO can impair female and male fertility. OGSIVEO has been shown to interfere with folliculogenesis and spermatogenesis in nonclinical studies resulting in changes that included ovarian atrophy [ see Nonclinical Toxicology ( 13.1 ) ].

8.4Pediatric Use The safety and effectiveness of OGSIVEO have not been established in pediatric patients. Epiphyseal disorder, manifesting as a widening of the epiphyseal growth plate, has been reported in pediatric patients with open growth plates treated with OGSIVEO.

8.5Geriatric Use Of the total number of OGSIVEO-treated patients in the DeFi study, 3 (4%) were 65 years of age and older and none were 75 years of age and older. Clinical studies of OGSIVEO did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently than younger adult patients.

🤰 Pregnancy 182 words ▾

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, OGSIVEO can cause fetal harm or loss of pregnancy when administered to a pregnant woman [ see C linical Pharmacology ( 12.1 ) ] . Oral administration of nirogacestat to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity and embryo-fetal death at maternal exposures below the human exposure at the recommended dose of 150 mg twice daily [see Data ] . There are no available data on the use of OGSIVEO in pregnant women.

Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Daily oral administration of nirogacestat to pregnant rats during the period of organogenesis resulted in decreased fetal body weights, pre- and post-implantation loss, and fetal subcutis edema at doses ≥ 20 mg/kg/day (approximately 0.85 times the recommended dose of 150 mg twice daily based on area under the curve).

🧒 Pediatric Use 40 words ▾

8.4Pediatric Use The safety and effectiveness of OGSIVEO have not been established in pediatric patients. Epiphyseal disorder, manifesting as a widening of the epiphyseal growth plate, has been reported in pediatric patients with open growth plates treated with OGSIVEO.

🧓 Geriatric Use 59 words ▾

8.5Geriatric Use Of the total number of OGSIVEO-treated patients in the DeFi study, 3 (4%) were 65 years of age and older and none were 75 years of age and older. Clinical studies of OGSIVEO did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently than younger adult patients.

🆘 Overdosage 24 words ▾

10 OVERDOSAGE Due to the high level of protein binding, OGSIVEO is not expected to be dialyzable [see Clinical Pharmacology ( 12.3 )] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Nirogacestat is a gamma secretase inhibitor that blocks proteolytic activation of the Notch receptor. When dysregulated, Notch can activate pathways that contribute to tumor growth.

12.2Pharmacodynamics Exposure-Response Relationships Higher nirogacestat exposure is associated with increased risk of Grade 3 decreased phosphate. Cardiac Electrophysiology At the recommended dosage, a mean increase in the QTc interval > 20 ms was not observed.

12.3Pharmacokinetics Nirogacestat pharmacokinetic parameters in patients with desmoid tumors are summarized in Table 6 . Table 6. Pharmacokinetic Parameters and Characteristics of Nirogacestat General Information Steady state exposure [Mean (%CV)] C max 508 (62) ng/mL AUC 0- tau 3370 (58) ng∙h/mL Time to steady-state Approximately 6 days Accumulation ratio [Median (Min, Max)] 1.6 (1.3, 4.6) Absorption T max [Median (Min, Max)] 1.5 (0.5, 6.5) hours Absolute bioavailability 19% Food effect [dose-normalized GMR% (90% CI)] C max 93 % (55%, 166%) AUC 114% (76%, 171%) Distribution Serum protein binding 99.6% Protein Binding* Human serum albumin 94.6% α-1 acid glycoprotein 97.9% Apparent volume of distribution (Vz/F) [Mean (%CV)] 1430 (65) L Elimination Apparent Systemic Clearance (CL/F) [Mean (%CV)] 45 (58) L/hr Terminal elimination half-life (t1/2) [Mean (%CV)] 23 (37) hr Metabolism Primary pathway N-dealkylation via CYP3A4 (85%) Secondary pathways Metabolism by CYP2C9, 2C19 and 2D6 Excretion Feces 38% Urine 17% (<1% unchanged) Expired air 9.7% * Protein binding values reflect results from separate assays.

Abbreviations: AUC 0-tau = area under the time concentration curve to the dosing interval; C max = maximum plasma concentration; T max = time to reach C max ; GMR = geometric mean ratio Specific Populations No clinically significant differences in the pharmacokinetics of nirogacestat were observed based on age (18 to 80 years), sex, race (Asian 2.1%, Black or African American 26%, and White 66%), or mild or moderate renal impairment (eGFR ≥ 41 mL/min/1.73m 2 ). Patients with Hepatic Impairment The mean AUC increased by up to 16% and the mean C max decreased by up to 39% in subjects with moderate hepatic impairment (Child-Pugh Class B or NCI-ODWG Group C).

The effect of severe hepatic impairment on nirogacestat pharmacokinetics is unknown. Drug Interaction Studies Clinical Studies and Model-Informed Approaches Strong and moderate CYP3A inhibitors: Nirogacestat C max increased 2.5-fold and AUC 8.2-fold following coadministration of a single dose of OGSIVEO (100 mg) with itraconazole (a strong CYP3A inhibitor). Nirogacestat AUC is predicted to increase 6.3-, 5.2-, and 3.5-fold following coadministration of OGSIVEO 150 mg BID with itraconazole, ketoconazole and clarithromycin (strong CYP3A inhibitors), respectively.

Nirogacestat AUC is predicted to increase 2.7- and 3.2-fold following coadministration of OGSIVEO 150 mg BID with erythromycin (moderate CYP3A inhibitor) and fluconazole (moderate CYP3A inhibitor), respectively. Strong and moderate CYP3A inducers: Nirogacestat AUC is predicted to decrease to 85% following coadministration of OGSIVEO 150 mg BID with rifampin (strong CYP3A inducer). Nirogacestat AUC is predicted to decrease to 67% following coadministration of OGSIVEO 150 mg BID with efavirenz (moderate CYP3A inducer).

CYP3A substrates: Midazolam (CYP3A substrate) C max is predicted to increase 1.8-fold and AUC by 2.1-fold following coadministration of OGSIVEO 150 mg BID. CYP2C19 substrates: Coadministration of OGSIVEO 150 mg BID with a drug that is a sensitive substrate of CYP2C19 decreases the plasma concentrations of these substrates. Gastric acid reducing agents : Coadministration of proton pump inhibitors (e.g., omeprazole), histamine type 2 (H2)-receptor antagonists (e.g., famotidine), or antacids (e.g., calcium) is expected to reduce concentrations of nirogacestat.

Other d rugs: No clinically significant differences in nirogacest…

🧬 Mechanism of Action 29 words ▾

12.1Mechanism of Action Nirogacestat is a gamma secretase inhibitor that blocks proteolytic activation of the Notch receptor. When dysregulated, Notch can activate pathways that contribute to tumor growth.

📦 How Supplied / Storage and Handling 114 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING OGSIVEO (nirogacestat) is supplied as 100 mg and 150 mg tablets. Each 100 mg light orange, film-coated tablet is debossed with a "100" on one face. Each 150 mg yellow orange, film-coated tablet is debossed with a "150" on one face.

Strength Description Each carton contains NDC 100 mg Round, light orange, film-coated tablet debossed with "100" on one side. One blister card with 14 tablets 82448-100-14 150 mg Oval, yellow orange, film-coated tablet debossed with "150" on one side. One blister card with 14 tablets 82448-150-14 Store at 20°C to 25°C (68°F to 77°F).

Excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.

📋 Description ~2 min read ▾

11 DESCRIPTION OGSIVEO oral tablets contain nirogacestat (as nirogacestat hydrobromide), a gamma (ɣ) secretase inhibitor. Nirogacestat hydrobromide is chemically known as (S)-2-(((S)-6,8-Difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl) pentanamide dihydrobromide. The empirical formula is C 27 H 43 Br 2 F 2 N 5 O and the molecular weight is 651.48 g/mol.

Nirogacestat hydrobromide is a white to off white powder with an aqueous solubility of 11.4 mg/mL and a pH of 4.4 in water at 25°C. Nirogacestat dihydrobromide is highly soluble at low pH, however the solubility significantly decreases at pH > 6.0. The molecule has pKa's of 5.77 and 7.13.

The structural formula for nirogacestat hydrobromide is: OGSIVEO (nirogacestat) tablets are immediate release (IR), film-coated tablets intended for oral administration. Each 100 mg tablet contains 100 mg nirogacestat as 133.050 mg nirogacestat hydrobromide. OGSIVEO 100 mg tablets are round, biconvex with an approximate diameter of 10 mm.

They are film coated, light orange in color, and debossed with "100" on one face and plain on the other face. Each 150 mg tablet contains 150 mg nirogacestat as 199.574 mg nirogacestat hydrobromide. OGSIVEO 150 mg tablets are oval, biconvex with approximate dimensions of 8.5 × 17.5 mm.

They are film coated, yellow orange in color, and debossed with "150" on one face and plain on the other face. OGSIVEO tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate type A. The tablets are finished with Opadry ® QX orange film coating consisting of the following ingredients: FD&C yellow #6/sunset yellow FCF aluminum lake, glycerol monocaprylocaprate type 1/mono/diglycerides, iron oxide yellow, macrogol (PEG) polyvinyl alcohol graft copolymer, polyvinyl alcohol – partially hydrolyzed, talc, and titanium dioxide.

The structural formula for nirogacestat hydrobromide is: OGSIVEO oral tablets contain nirogacestat (as nirogacestat hydrobromide), a gamma (ɣ) secretase inhibitor. Nirogacestat hydrobromide is chemically known as (S)-2-(((S)-6,8-Difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl) pentanamide dihydrobromide. The empirical formula is C27H43Br2F2N5O and the molecular weight is 651.48 g/mol.

Nirogacestat hydrobromide is a white to off white powder with an aqueous solubility of 11.4 mg/mL and a pH of 4.4 in water at 25C. Nirogacestat dihydrobromide is highly soluble at low pH, however the solubility significantly decreases at pH > 6.0. The molecule has pKa's of 5.77 and 7.13.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Diarrhea Advise patients that OGSIVEO can cause diarrhea, which may be severe, and to contact their healthcare provider for sustained diarrhea that does not respond to supportive care [ see Dosage and Administration ( 2.2 ) , Warnings and Precautions ( 5.1 ) ]. Ovarian Toxicity Advise females of reproductive potential that OGSIVEO can cause ovarian toxicity and impair fertility, and that these effects may continue following discontinuation of OGSIVEO.

Advise patients to tell their healthcare provider if they experience symptoms of ovarian toxicity, including hot flashes or menstrual irregularities [ see Warnings and Precautions ( 5.2 ) ]. Liver Toxicity Advise patients that OGSIVEO can cause ALT or AST elevations, and that their healthcare provider should monitor liver transaminase levels regularly [ see Dosage and Administration ( 2.2 ) , Warnings and Precautions ( 5.3 ) ]. Non-Melanoma Skin Cancers Advise patients that OGSIVEO can cause new non-melanoma skin cancers, that they will be monitored for these, and to contact their healthcare provider for any new or changing lesions on their skin [see Warnings and Precautions ( 5.4 ) ] .

Electrolyte Abnormalities Advise patients that OGSIVEO can cause hypophosphatemia and/or hypokalemia which may require phosphate and/or potassium supplementation. Advise patients that they will be monitored for these and to contact their healthcare provider if they experience muscle pain or weakness [ see Dosage and Administration ( 2.2 ) , Warnings and Precautions ( 5.5 ) ]. Hypersensitivity Advise patients that hypersensitivity reactions, including potentially severe reactions, may occur during treatment with OGSIVEO and to immediately report any signs and symptoms to their healthcare provider [see Dosage and Administration (2.2) , Warnings and Precautions (5.6) ].

Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential harm to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy, and to stop taking OGSIVEO if they become pregnant. Advise females of reproductive potential to use effective contraception during treatment with OGSIVEO and for 1 week after the last dose .

Addition of a barrier method is recommended for females using hormonal contraceptives. Advise males with female partners of reproductive potential to use effective contraception during treatment with OGSIVEO and for 1 week after the last dose [see Warnings and Precautions ( 5.7 ) , Use in Specific Populations ( 8.3 ) ]. Lactation Advise women not to breastfeed during treatment with OGSIVEO and for 1 week after the last dose [ see Use in Specific Populations ( 8.2 ) ] .

Drug Interactions Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products. Inform patients to avoid starfruit, Seville oranges, grapefruit, and juice from any of these fruits when taking OGSIVEO [see Drug Interactions ( 7 ) ]. Manufactured for: SpringWorks Therapeutics, Inc.

Stamford, CT 06902 OGSIVEO ® is a trademark of SpringWorks Therapeutics Operating Company, Inc. ©2026 SpringWorks Therapeutics, Inc.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82442-0998-01 · Target 82448-0130-42 · SpringWorks →
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.