Brukinsa Generic: When Will Generic Zanubrutinib 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
Brukinsa Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2036 to 2037 A wide window 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? January 2043 13 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 zanubrutinib is expected to be available between 2036 and 2037. None is for sale yet.
Why 2036 to 2037?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it probable: more likely than not, but it can still move.
If Brukinsa’s last patent runs to January 2043, how can a generic come sooner?
The 5 patents that run past the expected month, to January 2043 (11,701,357, 12,233,069, 11,786,531, 11,896,596 and 1 more), cover a way of using it and 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. Here, the companies are expected to settle on a date. Generic companies have been challenging Brukinsa’s patents with the FDA since November 2023. 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, and more so as more companies sell one. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic. See the price pattern
What should I do now?
Keep taking Brukinsa 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
- tablet2036 to 2037Probable · settlement expected
- capsule2036 to 2037Probable · settlement between companies
Our month is only an estimate based on available information, so we never name a day.
Brukinsa by the Numbers
- Reason
- Settlement expectedThe patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- Sales not reported
- FDA approved 2019 November 2019 FDA Orange Book
- Patents listed 13 last runs to January 2043 A generic is expected sooner, between 2036 and 2037. See why FDA Orange Book
- Medicare Part D spent $2.6B in 2025, for 23.8K people CMS Part D Spending by Drug
- Medicaid prescriptions 3,102 in the last four reported quarters, $44.4M CMS Medicaid drug utilization, to Q1 2026
Brukinsa’s Road to a Generic
Brukinsa has had the market to itself since the FDA approved it in November 2019 (Beone Medicines USA Inc). Its FDA protection (orphan drug) runs to March 2031. Its 13 listed patents run to January 2043. Generic companies have challenged its patents with the FDA since November 2023.
The first generic of Brukinsa is expected between 2036 and 2037.
Why that month: the patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
Why a Generic Can Come Before January 2043
The last listed patent runs to January 2043, but it covers a way of using it and 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.
Brukinsa Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Brukinsa’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.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,447,106 | The active ingredient; the product’s formulation; a way of using it (U-2145, U-1745, U-3063, U-2537, U-2666, U-3860, U-3486) | April 2034 | Active |
| 10,570,139 | A way of using it (U-1745, U-2666, U-2537, U-3860, U-3063, U-3486, U-2145) | April 2034 | Active |
| 11,142,528 | The product’s formulation; a way of using it (U-2666, U-2537, U-1745, U-2145, U-3063, U-3860, U-3486) | April 2034 | Active |
| 10,927,117 | The active ingredient; the product’s formulation | August 2037 | Active |
| 11,591,340 | A way of using it (U-1745, U-2145, U-2537, U-2666, U-3063, U-3486, U-3727, U-3729, U-3728) | August 2037 | Active |
| 11,851,437 | The active ingredient; the product’s formulation | August 2037 | Active |
| 11,884,674 | A way of using it (U-1745, U-2145, U-2537, U-2666, U-3063, U-3486, U-3860) | August 2037 | Active |
| 11,970,500 | A way of using it (U-1745, U-3860, U-3486, U-3063, U-2666, U-2537, U-2145) | August 2037 | Active |
| 11,701,357 | A way of using it (U-3860) | June 2039 | Active |
| 12,233,069 | The product’s formulation | June 2040 | Active |
| 11,786,531 | A way of using it (U-3875, U-3715, U-3716, U-3717, U-3718, U-3719, U-3720) | January 2043 | Active |
| 11,896,596 | A way of using it (U-3715, U-3720, U-3719, U-3718, U-3717, U-3716, U-3875) | January 2043 | Active |
| 11,911,386 | A way of using it (U-3715, U-3720, U-3719, U-3718, U-3717, U-3716, U-3875) | January 2043 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New use I-817 | Three years of protection for a newly approved use (indication). | January 2026 | Ended |
| Orphan drug ODE-276 | Seven years of protection for a use in a rare disease. | November 2026 | Active |
| New use I-936 | Three years of protection for a newly approved use (indication). | March 2027 | Active |
| Orphan drug ODE-371 | Seven years of protection for a use in a rare disease. | August 2028 | Active |
| Orphan drug ODE-370 | Seven years of protection for a use in a rare disease. | September 2028 | Active |
| Orphan drug ODE-274 | Seven years of protection for a use in a rare disease. | January 2030 | Active |
| FDA exclusivity ODE* | A period of protection the FDA granted (code ODE*). | March 2031 | Active |
| Orphan drug ODE-467 | Seven years of protection for a use in a rare disease. | March 2031 | Active |
Source: FDA Orange Book, application 213217, 218785. Patent numbers open the patent on Google Patents.
Patent Challenges to Brukinsa
The first patent challenge to Brukinsa reached the FDA in November 2023, from 2 companies on that first day. The FDA’s list has 2 entries for Brukinsa, by form and strength. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Brukinsa’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Capsules, 80 mg | November 2023 | 2 companies | No decision yet | Not yet | Not yet | January 2043 |
| Tablets, 160 mg | November 2025 | 1 company | No decision yet | Not yet | Not yet | January 2043 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Zanubrutinib
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
One company has applied to the FDA to make generic zanubrutinib.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for this one yet, so the company is not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Brukinsa’s patents with the FDA since November 2023: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic zanubrutinib. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic zanubrutinib 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).
Brukinsa 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 Brukinsa, 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 Brukinsa
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 Brukinsa, before manufacturer rebates.
- $769.3M
- January to March 2026, the latest CMS has posted
For 21,176 people, about $14,048 per prescription fill - $2.6B
- 2025, the whole year
For 23,841 people, about $13,431 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $769,288,412 | 21,176 | $14,047.59 |
| 2025 | $2,560,579,972 | 23,841 | $13,430.72 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Brukinsa only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat certain cancers (mantle cell lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinemia, chronic lymphocytic leukemia, small lymphocytic lymphoma, follicular lymphoma). Zanubrutinib belongs to a class of drugs known as kinase inhibitors.
Medicaid Prescriptions by Quarter
3,102 prescriptions in the four quarters to Q1 2026, $44.4M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 0 | $0 |
| Q4 2025 | 944 | $13,552,141 |
| Q3 2025 | 1,153 | $16,380,803 |
| Q2 2025 | 1,005 | $14,437,885 |
| Q1 2025 | 876 | $12,589,372 |
Source: CMS Medicaid State Drug Utilization Data, over Brukinsa’s own package codes.
Brukinsa Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 160MG | Tablet | Oral | June 2025 | Prescription reference product |
| 80MG | Capsule | Oral | November 2019 | Discontinued reference product |
Source: FDA Orange Book, Beone Medicines USA Inc. Listed for sale today by Beigene USA, Inc. and BeOne Medicines USA, Inc. (FDA NDC Directory).
Brukinsa NDC Codes and Packages
Each Brukinsa 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 |
|---|---|---|---|
| 72579-0122-01 | ZANUBRUTINIB 160 mg/1 tablet, film coated | bottle of 60 tablets | BeOne Medicines USA, Inc. |
| 72579-0011-02 | ZANUBRUTINIB 80 mg/1 capsule | bottle of 120 capsules | BeOne Medicines USA, Inc. |
| 72579-0011-02 | ZANUBRUTINIB 80 mg/1 capsule | bottle of 120 capsules | BeOne Medicines USA, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Brukinsa’s own FDA approval (NDA 213217, NDA 218785) are listed, never a generic. Some codes belong to companies that repackage Brukinsa: it is the same medicine in a different package.
What a Generic Brukinsa Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Brukinsa 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 Brukinsa”. 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 Brukinsa
Is there a generic for Brukinsa right now?
No. As of October 9, 2026 no generic zanubrutinib is listed for sale in the FDA NDC Directory.
When will Brukinsa go generic?
2036 to 2037 is the expected window, and that is probable but not certain. The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. The last listed patent runs to January 2043, but it covers a way of using it and the product’s formulation, not the medicine itself, which a generic can often work around or challenge.
Will generic zanubrutinib be the same as Brukinsa?
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. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Brukinsa?
Not yet. The FDA Orange Book lists no approved generic version of Brukinsa.
When does the Brukinsa patent expire?
The FDA Orange Book lists 13 patents for Brukinsa; the last runs to January 2043. 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 (2036 to 2037) weighs all of that.
Has anyone challenged the Brukinsa patents?
Yes. The first patent challenge to Brukinsa reached the FDA in November 2023, from 2 companies on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected 2036 to 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
- SernivoBetamethasone DipropionateDuring 2026
- VistogardUridine TriacetateAugust 2027
- IsentressRaltegravir PotassiumSeptember 2029
- Drizalma SprinkleDuloxetine HydrochlorideApril 2037
- AmbelvistGadoquatrane2039 to 2040
- OcalivaObeticholic AcidTBD no date yet
About Brukinsa
- Generic name zanubrutinib
- How it is taken By mouth
- Company Beone Medicines USA Inc
- Patent challenges Since November 2023 (FDA)
- More drugs Brand-name drugs starting with B
- Have a question? A pharmacist answers, free. Ask about Brukinsa
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, FDA Paragraph IV Patent Certifications list, 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.