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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 Ariad 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 sixty-seven patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for BRIGATINIB

International Patents:	67
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	42
Clinical Trials:	19
Patent Applications:	19
DailyMed Link:	BRIGATINIB at DailyMed

Recent Clinical Trials for BRIGATINIB

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

Sponsor	Phase
Takeda	Phase 1/Phase 2
Scott R. Plotkin, MD, PhD	Phase 2
The Children's Tumor Foundation	Phase 2

See all BRIGATINIB clinical trials

Pharmacology for BRIGATINIB

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

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

International Patents for BRIGATINIB

Country	Patent Number	Estimated Expiration
Mexico	2010012703
Eurasian Patent Organization	029131
Ecuador	SP17030878
Japan	6483233
Japan	2017186345
Hong Kong	1158497

Supplementary Protection Certificates for BRIGATINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2300013	19C1033	France		PRODUCT NAME: BRIGATINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/18/1264 20181126
2300013	1990030-7	Sweden		PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1264 20181126
2300013	300990	Netherlands		PRODUCT NAME: BRIGATINIB, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1264 20181126
2300013	LUC00120	Luxembourg		PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1264 20181126
2300013	C201930036	Spain		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
2300013	PA2019510	Lithuania		PRODUCT NAME: BRIGATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1264 20181122