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Last Updated: June 25, 2022

BRIGATINIB - Generic Drug Details


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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 eighty-five patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for BRIGATINIB
International Patents:85
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 54
Clinical Trials: 27
Patent Applications: 1,453
What excipients (inactive ingredients) are in BRIGATINIB?BRIGATINIB excipients list
DailyMed Link:BRIGATINIB at DailyMed
Recent Clinical Trials for BRIGATINIB

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

SponsorPhase
Yonsei UniversityPhase 2
Nuvalent Inc.Phase 1/Phase 2
Princess Maxima Center for Pediatric OncologyPhase 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 208772-002 Apr 28, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa ALUNBRIG brigatinib TABLET;ORAL 208772-003 Oct 2, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa ALUNBRIG brigatinib TABLET;ORAL 208772-003 Oct 2, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa ALUNBRIG brigatinib TABLET;ORAL 208772-002 Apr 28, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Takeda Pharms Usa ALUNBRIG brigatinib TABLET;ORAL 208772-002 Apr 28, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

International Patents for BRIGATINIB

Country Patent Number Title Estimated Expiration
Lithuania C2300013 See Plans and Pricing
Spain 2645689 See Plans and Pricing
Ecuador SP17030878 FORMAS CRISTALINAS DE 5-CLORO-N4-[2-(DIMETILFOSFORIL)FENIL]-N2-{2-METOXI-4-[4-(4-METILPIPERAZIN-1-IL)PIPERIDIN-1-IL]PIRIMIDINA-2,4-DIAMINA See Plans and Pricing
Israel 208716 תולדות זרחן כמעכבי קינאז (Phosphorus derivatives as kinase inhibitors) See Plans and Pricing
Slovenia 3209647 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BRIGATINIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2300013 PA2019510,C2300013 Lithuania See Plans and Pricing PRODUCT NAME: BRIGATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1264 20181122
2300013 C20190026 00287 Estonia See Plans and Pricing PRODUCT NAME: BRIGATINIIB;REG NO/DATE: EU/1/18/1264 26.11.2018
2300013 132019000000069 Italy See Plans and Pricing PRODUCT NAME: BRIGATINIB, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ALUNBRIG); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1264, 20181126
2300013 31/2019 Austria See Plans and Pricing PRODUCT NAME: BRIGATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1264 (MITTEILUNG) 20181126
2300013 C201930036 Spain See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Johnson and Johnson

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.