You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 24, 2024

BRIGATINIB - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for brigatinib and what is the scope of patent protection?

Brigatinib is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brigatinib has ninety patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for BRIGATINIB
International Patents:90
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 61
Clinical Trials: 29
Patent Applications: 1,537
What excipients (inactive ingredients) are in BRIGATINIB?BRIGATINIB excipients list
DailyMed Link:BRIGATINIB at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BRIGATINIB
Generic Entry Date for BRIGATINIB*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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 BRIGATINIB

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

SponsorPhase
ETOP IBCSG Partners FoundationPhase 2
Yonsei UniversityPhase 2
Nuvalent Inc.Phase 1/Phase 2

See all BRIGATINIB clinical trials

Pharmacology for BRIGATINIB

US Patents and Regulatory Information for BRIGATINIB

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa ALUNBRIG brigatinib TABLET;ORAL 208772-003 Oct 2, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa ALUNBRIG brigatinib TABLET;ORAL 208772-002 Apr 28, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa ALUNBRIG brigatinib TABLET;ORAL 208772-003 Oct 2, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Takeda Pharms Usa ALUNBRIG brigatinib TABLET;ORAL 208772-003 Oct 2, 2017 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 BRIGATINIB

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Takeda Pharma A/S Alunbrig brigatinib EMEA/H/C/004248
Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase ALKpositive advanced NSCLC previously treated with crizotinib.
Authorised no no no 2018-11-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for BRIGATINIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2300013 2019/031 Ireland ⤷  Sign Up PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/18/1264 20181122
2300013 C201930036 Spain ⤷  Sign Up PRODUCT NAME: BRIGATINIB, O SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/18/1264; DATE OF AUTHORISATION: 20181122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1264; DATE OF FIRST AUTHORISATION IN EEA: 20181122
2300013 363 50014-2019 Slovakia ⤷  Sign Up OWNER(S): TAKEDA PHARMACEUTICAL COMPANY LIMITED, CHUO-KU, OSAKA-SHI, OSAKA, JP; PREDCHADZAJUCI MAJITEL: DYAX CORP., LEXINGTON, MA, US; DATUM ZAPISU DO REGISTRA: 4.4.2022
2300013 PA2019510,C2300013 Lithuania ⤷  Sign Up PRODUCT NAME: BRIGATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1264 20181122
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.