Brukinsa is a drug owned by Beone Medicines Usa Inc. It is protected by 13 US drug patents filed from 2021 to 2025 out of which none have expired yet. Brukinsa's patents have been open to challenges since 15 November, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 19, 2043. Details of Brukinsa's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US11851437 | Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof |
Aug, 2037
(10 years from now) | Active |
| US10927117 | Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof |
Aug, 2037
(10 years from now) | Active |
| US9447106 | Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators |
Apr, 2034
(7 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11896596 | Methods of treating B-cell proliferative disorder |
Jan, 2043
(16 years from now) | Active |
| US11786531 | Methods of treating B-cell proliferative disorder |
Jan, 2043
(16 years from now) | Active |
| US11911386 | Methods of treating B-cell proliferative disorder |
Jan, 2043
(16 years from now) | Active |
| US12233069 | Oral solid tablet comprising Bruton's Tyrosine Kinase inhibitor and preparation method therefor |
Jun, 2040
(13 years from now) | Active |
| US11701357 | Treatment of B cell cancers using a combination comprising Btk inhibitors |
Jun, 2039
(12 years from now) | Active |
| US11884674 | Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof |
Aug, 2037
(10 years from now) | Active |
| US11591340 | Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof |
Aug, 2037
(10 years from now) | Active |
| US11970500 | Crystalline form of (s)-7-(1-acryloylpiperidin-4-yl)- 2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof |
Aug, 2037
(10 years from now) | Active |
| US10570139 | Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators |
Apr, 2034
(7 years from now) | Active |
| US11142528 | Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators |
Apr, 2034
(7 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Brukinsa's patents.
Latest Legal Activities on Brukinsa's Patents
Given below is the list of recent legal activities going on the following patents of Brukinsa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Mar, 2025 | US11142528 |
| Patent eGrant Notification | 25 Feb, 2025 | US12233069 |
| Recordation of Patent Grant Mailed | 25 Feb, 2025 | US12233069 |
| Recordation of Patent eGrant | 25 Feb, 2025 | US12233069 |
| Patent Issue Date Used in PTA Calculation | 25 Feb, 2025 | US12233069 |
| Mail Patent eGrant Notification | 25 Feb, 2025 | US12233069 |
| Email Notification | 25 Feb, 2025 | US12233069 |
| Change in Power of Attorney (May Include Associate POA) | 20 Feb, 2025 | US11142528 |
| Email Notification | 20 Feb, 2025 | US11142528 |
| Issue Notification Mailed | 05 Feb, 2025 | US12233069 |
FDA has granted several exclusivities to Brukinsa. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Brukinsa, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Brukinsa.
Exclusivity Information
Brukinsa holds 11 exclusivities out of which 4 have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Brukinsa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-871) | Aug 31, 2024 |
| New Indication(I-874) | Sep 14, 2024 |
| New Chemical Entity Exclusivity(NCE) | Nov 14, 2024 |
| New Indication(I-817) | Jan 19, 2026 |
| Orphan Drug Exclusivity(ODE-276) | Nov 14, 2026 |
| New Indication(I-936) | Mar 07, 2027 |
| Orphan Drug Exclusivity(ODE-371) | Aug 31, 2028 |
| ODE*(ODE*) | Sep 14, 2028 |
| Orphan Drug Exclusivity(ODE-370) | Sep 14, 2028 |
| Orphan Drug Exclusivity(ODE-274) | Jan 19, 2030 |
| Orphan Drug Exclusivity(ODE-467) | Mar 07, 2031 |
US patents provide insights into the exclusivity only within the United States, but
Brukinsa is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Brukinsa's family patents as well as insights into
ongoing legal events
on those patents.
Brukinsa's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Brukinsa:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Brukinsa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 19, 2043 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Brukinsa Generics:
There are no approved generic versions for Brukinsa as of now.
How can I launch a generic of Brukinsa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Brukinsa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Brukinsa's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Brukinsa -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 13 Nov, 2025 | 19 Jan, 2043 | Less | |||
| 14 Nov, 2023 | 19 Jan, 2043 | Less |
Alternative Brands for Brukinsa
Brukinsa which is used for treating adult patients with various types of lymphomas and leukemias who have not responded to prior therapies., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Astrazeneca |
| |||
About Brukinsa
Brukinsa is a drug owned by Beone Medicines Usa Inc. It is used for treating adult patients with various types of lymphomas and leukemias who have not responded to prior therapies. Brukinsa uses Zanubrutinib as an active ingredient. Brukinsa was launched by Beone Medicines in 2019.
Approval Date:
Brukinsa was approved by FDA for market use on 14 November, 2019.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Brukinsa is 14 November, 2019, its NCE-1 date is estimated to be 15 November, 2023.
Active Ingredient:
Brukinsa uses Zanubrutinib as the active ingredient. Check out other Drugs and Companies using Zanubrutinib ingredient
Treatment:
Brukinsa is used for treating adult patients with various types of lymphomas and leukemias who have not responded to prior therapies.
Dosage:
Brukinsa is available in the following dosage forms - capsule form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 80MG | CAPSULE | Discontinued | ORAL |
| 160MG | TABLET | Prescription | ORAL |