Brigatinib - Generic Drug Details

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

Sponsor	Phase
Yonsei University	Phase 2
Nuvalent Inc.	Phase 1/Phase 2
Princess Maxima Center for Pediatric Oncology	Phase 1/Phase 2

See all brigatinib clinical trials

Pharmacology for brigatinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A Inducers Tyrosine Kinase Inhibitors

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
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	Apr 28, 2017		RX	Yes	No
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-002	Apr 28, 2017		RX	Yes	No
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	Apr 28, 2017		RX	Yes	No			Y	Y
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-003	Oct 2, 2017		RX	Yes	Yes

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

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
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
Eurasian Patent Organization	201071339	ФОСФОРСОДЕРЖАЩИЕ ПРОИЗВОДНЫЕ В КАЧЕСТВЕ ИНГИБИТОРОВ КИНАЗЫ
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)
Japan	6483233

Supplementary Protection Certificates for brigatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2300013	2019C/525	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2300013	300990	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2300013	363 50014-2019	Slovakia		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		PRODUCT NAME: BRIGATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1264 20181122
2300013	SPC/GB19/036	United Kingdom		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