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-three patent family members in thirty 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: | 73 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BRUKINSA
*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
| Sponsor | Phase |
|---|---|
| Stichting Hemato-Oncologie voor Volwassenen Nederland | Phase 2 |
| International Extranodal Lymphoma Study Group (IELSG) | Phase 3 |
| City of Hope Medical Center | Phase 2 |
Pharmacology for BRUKINSA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Bruton's Tyrosine Kinase Inhibitors |
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 | |||
| Beigene | BRUKINSA | zanubrutinib | CAPSULE;ORAL | 213217-001 | Nov 14, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Beigene | BRUKINSA | zanubrutinib | CAPSULE;ORAL | 213217-001 | Nov 14, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | 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
Estimated Expiration: ⤷ Sign Up
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)
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
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)
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2604975
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Patent: 190032613
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Patent: 230162137
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 60356
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Mexico | 2019001900 | 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.) | ⤷ Sign Up |
| Netherlands | 301161 | ⤷ Sign Up | |
| Eurasian Patent Organization | 028756 | КОНДЕНСИРОВАННЫЕ ГЕТЕРОЦИКЛИЧЕСКИЕ СОЕДИНЕНИЯ В КАЧЕСТВЕ ИНГИБИТОРОВ ПРОТЕИНКИНАЗЫ (FUSED HETEROCYCLIC COMPOUNDS AS PROTEIN KINASE INHIBITORS) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2018033853 | ⤷ Sign Up | |
| Japan | 2022071072 | （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 | ⤷ 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 | SPC/GB22/006 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ZANUBRUTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/21/1576 (NI) 20211122; UK FURTHER MA ON IPSUM 20211122 |
| 2989106 | CR 2022 00008 | Denmark | ⤷ Sign Up | PRODUCT NAME: ZANUBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1576 20211123 |
| 2989106 | 301161 | Netherlands | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
| 2989106 | 4/2022 | Austria | ⤷ Sign Up | PRODUCT NAME: ZANUBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1576 (MITTEILUNG) 20211123 |
| 2989106 | C02989106/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: BEIGENE, LTD., KY |
| >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.
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