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

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
Croatia	P20201343
European Patent Office	3209647	FORMES CRISTALLINES DE 5-CHLORO-N4- [-2- (DIMÉTHYLPHOSPHORYL) PHÉNYL]-N2- {2-MÉTHOXY-4- [4- (4-MÉTHYLPIPÉRAZIN-1-YL) PIPÉRIDIN-1-YL]PYRIMIDINE-2,4-DIAMINE (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)
South Korea	101956261

Supplementary Protection Certificates for brigatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2300013	2019/031	Ireland		PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/18/1264 20181122
2300013	122019000046	Germany		PRODUCT NAME: BRIGATINIB, ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1264 20181122
2300013	LUC00120	Luxembourg		PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1264 20181126