BRIGATINIB - Generic Drug Details

What are the generic drug 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-eight patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for BRIGATINIB

International Patents:	88
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	28
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

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

Sponsor	Phase
ETOP IBCSG Partners Foundation	Phase 2
Yonsei University	Phase 2
Nuvalent Inc.	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	208772-002	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	208772-003	Oct 2, 2017		RX	Yes	Yes			Y	Y

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
China	111825717	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]苯基}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)
Serbia	60737	KRISTALNI OBLICI 5-HLORO-N4-[-2-(DIMETILFOSFORIL)FENIL]-N2-{2-METOKSI-4-[4-(4-METILPIPERAZIN-1-IL)PIPERIDIN-1-IL]PIRIMIDIN-2,4-DIAMINA (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)
Slovenia	3209647

Supplementary Protection Certificates for BRIGATINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2300013	1990030-7	Sweden		PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1264 20181126
2300013	CA 2019 00028	Denmark		PRODUCT NAME: BRIGATINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; REG. NO/DATE: EU/1/18/1264 20181126
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