Jaypirca Generic: When Will Generic Pirtobrutinib Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Jaypirca Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? During 2037 Sometime that year Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? September 2041 7 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic pirtobrutinib is expected to be available sometime in 2037. None is for sale yet.
Why 2037?
It is when Jaypirca’s patent 10,342,780 ends. That patent covers the active ingredient and the product’s formulation, and once it ends, generics should be able to go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
If Jaypirca’s last patent runs to September 2041, how can a generic come sooner?
The 2 patents that run past the expected month, to September 2041 (12,268,666 and 12,109,193), cover the product’s formulation. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. That is why the expected month comes before the last protection ends. See the road to a generic
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Jaypirca as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Jaypirca by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- $527M a yearBig seller
- FDA approved 2023 January 2023 FDA Orange Book
- Patents listed 7 last runs to September 2041 A generic is expected sooner, sometime in 2037. See why FDA Orange Book
- Medicare Part D spent $379M in 2025, for 2,893 people CMS Part D Spending by Drug
- Medicaid prescriptions 172 in the last four reported quarters, $3.9M CMS Medicaid drug utilization, to Q1 2026
Jaypirca’s Road to a Generic
Jaypirca has had the market to itself since the FDA approved it in January 2023 (Loxo Oncology Inc). Its FDA protection (orphan drug) runs to December 2032. Its 7 listed patents run to September 2041.
The first generic of Jaypirca is expected sometime in 2037.
Why that month: patent 10,342,780, on the active ingredient and the product’s formulation, ends then.
Why a Generic Can Come Before September 2041
The last listed patent runs to September 2041, but it covers the product’s formulation, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Jaypirca Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Jaypirca’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
The one that matters for a generic launch: patent 10,342,780, which ends in December 2036; the first generic is expected after it, sometime in 2037. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,342,780 Sets the expected month of generic availability | The active ingredient; the product’s formulation | December 2036 | Active |
| 10,464,905 | A way of using it (U-3518, U-4362) | December 2036 | Active |
| 10,695,323 | The active ingredient; the product’s formulation; a way of using it (U-3518, U-4362) | December 2036 | Active |
| 10,918,622 | A way of using it (U-3518, U-4362) | December 2036 | Active |
| 12,220,401 | The active ingredient; the product’s formulation; a way of using it (U-3518, U-4362) | December 2036 | Active |
| 12,268,666 | The product’s formulation | July 2039 | Active |
| 12,109,193 | The product’s formulation | September 2041 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | January 2028 | Active |
| New use I-981 | Three years of protection for a newly approved use (indication). | December 2028 | Active |
| Orphan drug ODE-424 | Seven years of protection for a use in a rare disease. | January 2030 | Active |
| Orphan drug ODE-451 | Seven years of protection for a use in a rare disease. | December 2030 | Active |
| Orphan drug ODE-518 | Seven years of protection for a use in a rare disease. | December 2032 | Active |
Source: FDA Orange Book, application 216059. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Pirtobrutinib
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No company is recorded as having applied to the FDA to make a generic Jaypirca yet.
Approved by the FDA
Not yet. The FDA has not approved a generic pirtobrutinib. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic pirtobrutinib for sale with the FDA.
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Jaypirca Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Jaypirca, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Jaypirca
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Jaypirca, before manufacturer rebates.
- $131.1M
- January to March 2026, the latest CMS has posted
For 2,525 people, about $21,022 per prescription fill - $379M
- 2025, the whole year
For 2,893 people, about $20,855 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $131,137,630 | 2,525 | $21,022.38 |
| 2025 | $378,957,353 | 2,893 | $20,855.06 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Jaypirca only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat certain types of cancer (such as mantle cell lymphoma-MCL, chronic lymphocytic leukemia-CLL, small lymphocytic lymphoma-SLL). Pirtobrutinib belongs to a class of drugs known as kinase inhibitors.
Medicaid Prescriptions by Quarter
172 prescriptions in the four quarters to Q1 2026, $3.9M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 50 | $1,142,581 |
| Q4 2025 | 49 | $1,118,055 |
| Q3 2025 | 52 | $1,198,730 |
| Q2 2025 | 21 | $477,884 |
| Q1 2025 | 20 | $429,098 |
Source: CMS Medicaid State Drug Utilization Data, over Jaypirca’s own package codes.
Jaypirca Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MG | Tablet | Oral | January 2023 | Prescription reference product |
| 50MG | Tablet | Oral | January 2023 | Prescription reference product |
Source: FDA Orange Book, Loxo Oncology Inc. Listed for sale today by Eli Lilly and Company (FDA NDC Directory).
Jaypirca NDC Codes and Packages
Each Jaypirca package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 00002-7026-60 | PIRTOBRUTINIB 100 mg/1 tablet, coated | bottle of 60 tablets | Eli Lilly and Company |
| 00002-7026-60 | PIRTOBRUTINIB 100 mg/1 tablet, coated | bottle of 60 tablets | Eli Lilly and Company |
| 00002-7026-99 | PIRTOBRUTINIB 100 mg/1 tablet, coated | bottle of 30 tablets | Eli Lilly and Company |
| 00002-7026-99 | PIRTOBRUTINIB 100 mg/1 tablet, coated | bottle of 30 tablets | Eli Lilly and Company |
| 00002-6902-30 | PIRTOBRUTINIB 50 mg/1 tablet, coated | bottle of 30 tablets | Eli Lilly and Company |
| 00002-6902-30 | PIRTOBRUTINIB 50 mg/1 tablet, coated | bottle of 30 tablets | Eli Lilly and Company |
Source: the FDA NDC Directory, current listings only. Only packages sold under Jaypirca’s own FDA approval (NDA 216059) are listed, never a generic. Some codes belong to companies that repackage Jaypirca: it is the same medicine in a different package.
What a Generic Jaypirca Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Jaypirca as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Jaypirca”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Jaypirca
Is there a generic for Jaypirca right now?
No. As of October 9, 2026 no generic pirtobrutinib is listed for sale in the FDA NDC Directory.
When will Jaypirca go generic?
Sometime in 2037 is the expected window, and that is probable but not certain. It is when Jaypirca’s patent 10,342,780 ends. That patent covers the active ingredient and the product’s formulation, and once it ends, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to September 2041, but it covers the product’s formulation, not the medicine itself, which a generic can often work around or challenge.
Will generic pirtobrutinib be the same as Jaypirca?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Jaypirca?
Not yet. The FDA Orange Book lists no approved generic version of Jaypirca.
When does the Jaypirca patent expire?
The FDA Orange Book lists 7 patents for Jaypirca; the last runs to September 2041. The one behind the expected month is patent 10,342,780, which ends in December 2036. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected window on this page (Sometime in 2037) weighs all of that.
Changes to This Projection
- First generic expected Sometime in 2037 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- CerdelgaEliglustat TartrateJuly to December 2026
- Quillivant XRMethylphenidate HydrochlorideFebruary 2031
- ZilrettaTriamcinolone AcetonideAugust 2031
- GimotiMetoclopramide2032 to 2033
- TryngolzaOlezarsen SodiumFebruary 2038
- LyvispahBaclofenJuly 2039
About Jaypirca
- Generic name pirtobrutinib
- How it is taken By mouth
- Company Loxo Oncology Inc
- More drugs Brand-name drugs starting with J
- Have a question? A pharmacist answers, free. Ask about Jaypirca
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.