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Last Updated: December 8, 2022

Brigatinib - Generic Drug Details


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What are the generic sources for brigatinib and what is the scope of freedom to operate?

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-six patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for brigatinib
International Patents:86
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 56
Clinical Trials: 27
Patent Applications: 1,953
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 208772-001 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 208772-001 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 208772-002 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 208772-001 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 208772-003 Oct 2, 2017 RX Yes Yes 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
Japan 2017535538 5−クロロ−N4−[2−(ジメチルホスホリル)フェニル]−N2−{2−メトキシ−4−[4−(4−メチルピペラジン−1−イル)ピペリジン−1−イル]ピリミジン−2,4−ジアミンの結晶形態 See Plans and Pricing
Peru 20171344 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
Eurasian Patent Organization 201071339 ФОСФОРСОДЕРЖАЩИЕ ПРОИЗВОДНЫЕ В КАЧЕСТВЕ ИНГИБИТОРОВ КИНАЗЫ See Plans and Pricing
China 107108559 5‑氯‑N4‑[2‑(二甲基磷酰基)苯基]‑N2‑{2‑甲氧基‑4‑[4‑(4‑甲基哌嗪‑1‑基)哌啶‑1‑基]嘧啶‑2,4‑二胺的晶形 (Crystalline forms of 5-chloro-n4-[-2-(dimethylphosphoryl) phenyl]-n2-{2-methoxy-4-[4-(4-methylpiperazin-1-yl) piperidin-1-yl] pyrimidine-2,4-diamine) See Plans and Pricing
Japan 6483233 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 2019C/525 Belgium See Plans and Pricing DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2300013 300990 Netherlands See Plans and Pricing DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2300013 363 50014-2019 Slovakia See Plans and Pricing 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 Lithuania See Plans and Pricing PRODUCT NAME: BRIGATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1264 20181122
2300013 SPC/GB19/036 United Kingdom See Plans and Pricing PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/18/1264 (NI) 20181126; UK PLGB 15475/0037 20181126; UK PLGB 15475/0038 20181126; UK PLGB 15475/0039 20181126; UK PLGB 15475/0075 20181126
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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