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Last Updated: October 5, 2024

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BRUKINSA Drug Patent Profile


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When do Brukinsa patents expire, and when can generic versions of Brukinsa launch?

Brukinsa is a drug marketed by Beigene and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-one patent family members in twenty-nine countries.

The generic ingredient in BRUKINSA is zanubrutinib. One supplier is listed for this compound. Additional details are available on the zanubrutinib profile page.

DrugPatentWatch® Generic Entry Outlook for Brukinsa

Brukinsa was eligible for patent challenges on November 14, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 15, 2037. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for BRUKINSA
International Patents:71
US Patents:12
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 38
Clinical Trials: 28
Patent Applications: 69
Drug Prices: Drug price information for BRUKINSA
What excipients (inactive ingredients) are in BRUKINSA?BRUKINSA excipients list
DailyMed Link:BRUKINSA at DailyMed
Drug patent expirations by year for BRUKINSA
Drug Prices for BRUKINSA

See drug prices for BRUKINSA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BRUKINSA
Generic Entry Date for BRUKINSA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BRUKINSA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Stichting Hemato-Oncologie voor Volwassenen NederlandPhase 2
International Extranodal Lymphoma Study Group (IELSG)Phase 3
City of Hope Medical CenterPhase 2

See all BRUKINSA clinical trials

Pharmacology for BRUKINSA
Paragraph IV (Patent) Challenges for BRUKINSA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BRUKINSA Capsules zanubrutinib 80 mg 213217 2 2023-11-14

US Patents and Regulatory Information for BRUKINSA

BRUKINSA is protected by sixty-eight US patents and ten FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BRUKINSA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting BRUKINSA

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydrop- yrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) RECEIVING A MODERATE CYP3A INDUCER, IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA (WM) RECEIVING A MODERATE CYP3A INDUCER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE ANTI–CD20-BASED REGIMEN


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) RECEIVING A MODERATE CYP3A INDUCER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) RECEIVING A MODERATE CYP3A INDUCER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE ANTI–CD20-BASED REGIMEN


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA (WM) RECEIVING A MODERATE CYP3A INDUCER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) RECEIVING A MODERATE CYP3A INDUCER, IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) RECEIVING A MODERATE CYP3A INDUCER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE ANTI–CD20-BASED REGIMEN


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA (WM) RECEIVING A MODERATE CYP3A INDUCER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) RECEIVING A MODERATE CYP3A INDUCER, IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA

Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN

Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)

Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY

Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA

FDA Regulatory Exclusivity protecting BRUKINSA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Exclusivity Expiration: ⤷  Sign Up

INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE ANTI-CD20-BASED REGIMEN
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT PATIENTS WITH WALDENSTRӦM’S MACROGLOBULINEMIA (WM)
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE ANTI-CD20-BASED REGIMEN
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Beigene BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Beigene BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Beigene BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for BRUKINSA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
BeiGene Ireland Ltd Brukinsa zanubrutinib EMEA/H/C/004978
Brukinsa as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.Brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.Brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL).
Authorised no no no 2021-11-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for BRUKINSA

When does loss-of-exclusivity occur for BRUKINSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 17314178
Patent: 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
Estimated Expiration: ⤷  Sign Up

Patent: 22200278
Patent: CRYSTALLINE FORM OF (S)-7-(1-ACRYLOYLPIPERIDIN-4-YL)-2-(4-PHENOXYPHENYL)-4,5,6,7-TETRA-HY DROPYRAZOLO[1,5-A]PYRIMIDINE-3-CARBOXAMIDE, PREPARATION, AND USES THEREOF
Estimated Expiration: ⤷  Sign Up

Patent: 24200030
Patent: 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
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2019003205
Patent: forma cristalina de (s) -7- (1-acriloilpiperidin-4-il) -2- (4-fenoxifenil) -4,5,6,7-tetra-hidropirazol [1,5-a] pirimidina-3-carboxamida, sua preparação e seus usos
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 33827
Patent: FORME CRISTALLINE DE (S)-7-(1-ACRYLOYLPIPERIDIN-4-YL)-2-(4-PHENOXYPHENYLE)-4,5,6,7-TETRA-HYDROPYRAZOLO[1,5-A]PYRIMIDINE-3-CARBOXAMIDE, SA PREPARATION ET SES UTILISATIONS (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)
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China

Patent: 9563099
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Patent: 6478165
Patent: 一种化合物的晶型、其制备和用途 (Crystal form of compound as well as preparation and application thereof)
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Patent: 6478166
Patent: 一种化合物的晶型、其制备和用途 (Crystal form of compound as well as preparation and application thereof)
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 1990519
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА (S)-7-(1-АКРИЛОИЛПИПЕРИДИН-4-ИЛ)-2-(4-ФЕНОКСИФЕНИЛ)-4,5,6,7-ТЕТРАГИДРОПИРАЗОЛО[1,5-a]ПИРИМИДИН-3-КАРБОКСАМИДА, ЕЕ ПОЛУЧЕНИЕ И ПРИМЕНЕНИЯ
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European Patent Office

Patent: 00575
Patent: FORME CRISTALLINE DE (S)-7-(1-ACRYLOYLPIPÉRIDIN-4-YL)-2-(4-PHÉNOXYPHÉNYLE)-4,5,6,7-TÉTRA-HYDROPYRAZOLO[1,5-A]PYRIMIDINE-3-CARBOXAMIDE, SA PRÉPARATION ET SES UTILISATIONS (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)
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Patent: 53322
Patent: FORME CRISTALLINE DU (S)-7-(1-ACRYLOYLPIPÉRIDIN-4-YL)-2-(4-PHÉNOXYPHÉNYL)-4,5,6,7-TÉTRA-HYDROPYRAZOLO[1,5-A!PYRIMIDINE-3-CARBOXAMIDE, PRÉPARATION ET UTILISATIONS ASSOCIÉES (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)
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Israel

Patent: 4784
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Patent: 3319
Patent: מבנה גבישי של s)-7-(1-acryloylpiperidin-4-yl)-2-(4-) phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo(1,5-a)pyrimidine-3-carboxamide, שיטות הכנה ושימושים בו (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)
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Japan

Patent: 02685
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Patent: 13419
Estimated Expiration: ⤷  Sign Up

Patent: 19528276
Patent: (S)−7−(1−アクリロイルピペリジン−4−イル)−2−(4−フェノキシフェニル)−4,5,6,7−テトラ−ヒドロピラゾロ[1,5−A]ピリミジン−3−カルボキサミドの結晶形、その調製、及びその使用
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Patent: 22071072
Patent: (S)-7-(1-アクリロイルピペリジン-4-イル)-2-(4-フェノキシフェニル)-4,5,6,7-テトラ-ヒドロピラゾロ[1,5-A]ピリミジン-3-カルボキサミドの結晶形、その調製、及びその使用
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Patent: 24026550
Patent: (S)-7-(1-アクリロイルピペリジン-4-イル)-2-(4-フェノキシフェニル)-4,5,6,7-テトラ-ヒドロピラゾロ[1,5-A]ピリミジン-3-カルボキサミドの結晶形、その調製、及びその使用
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Mexico

Patent: 19001900
Patent: FORMA CRISTALINA DE (S)-7-(1-ACRILOILPIPERIDIN-4-IL)-2-(4-FENOXIFE NIL)-4,5,6,7-TETRA-HIDROPIRAZOLO[1,5-A]PIRIMIDIN-3-CARBOXAMIDA, PREPARACION Y USOS DE LA MISMA. (CRYSTALLINE FORM OF (S)-7-(1-ACRYLOYLPIPERIDIN-4-YL)-2-(4-PHENOXY PHENYL)-4,5,6,7-TETRA-HYDROPYRAZOLO[1,5-A]PYRIMIDINE-3-CARBOXAMI DE, PREPARATION, AND USES THEREOF.)
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New Zealand

Patent: 1418
Patent: 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
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Singapore

Patent: 201901141W
Patent: 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
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South Africa

Patent: 1900919
Patent: 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
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South Korea

Patent: 2604975
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Patent: 190032613
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Patent: 230162137
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Taiwan

Patent: 60356
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Patent: 1811794
Patent: Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetrahydropyrazolo[1,5-A]pyrimidine-3-carboxamide, preparation, and uses thereof
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Patent: 2233628
Patent: Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetrahydropyrazolo[1,5-A]pyrimidine-3-carboxamide, preparation, and uses thereof
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Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BRUKINSA around the world.

Country Patent Number Title Estimated Expiration
Singapore 11201506764W FUSED HETEROCYCLIC COMPOUNDS AS PROTEIN KINASE INHIBITORS ⤷  Sign Up
France 22C1010 ⤷  Sign Up
Hong Kong 1222174 作為蛋白激酶抑制劑的稠合雜環化合物 (FUSED HETEROCYCLIC COMPOUNDS AS PROTEIN KINASE INHIBITORS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BRUKINSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2989106 C202230011 Spain ⤷  Sign Up PRODUCT NAME: ZANUBRUTINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/21/1576; DATE OF AUTHORISATION: 20211122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1576; DATE OF FIRST AUTHORISATION IN EEA: 20211122
2989106 122022000013 Germany ⤷  Sign Up PRODUCT NAME: ZANUBRUTINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1576 20211122
2989106 PA2022504 Lithuania ⤷  Sign Up PRODUCT NAME: ZANUBRUTINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1576 20211121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.