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 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 ninety patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for BRIGATINIB

International Patents:	90
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	29
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

Generic Entry Date for BRIGATINIB^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Anatomical Therapeutic Chemical (ATC) Classes for BRIGATINIB

L01ED	Anaplastic lymphoma kinase (ALK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for BRIGATINIB

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Glossary

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

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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

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Country	Patent Number	Title	Estimated Expiration
Japan	2017186345	キナーゼ阻害剤としてのリン誘導体 (PHOSPHOROUS DERIVATIVES AS KINASE INHIBITORS)	⤷ Sign Up
Denmark	3209647		⤷ Sign Up
Eurasian Patent Organization	035145	КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 5-ХЛОР-N4-[2-(ДИМЕТИЛФОСФОРИЛ)ФЕНИЛ]-N2-{2-МЕТОКСИ-4-[4-(4-МЕТИЛПИПЕРАЗИН-1-ИЛ)ПИПЕРИДИН-1-ИЛ]ФЕНИЛ}ПИРИМИДИН-2,4-ДИАМИНА (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)	⤷ Sign Up
Lithuania	3209647		⤷ Sign Up
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	⤷ Sign Up
Croatia	P20201343		⤷ Sign Up
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)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BRIGATINIB

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2300013	2019024	Norway	⤷ Sign Up	PRODUCT NAME: BRIGATINIB ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/18/1264 20181218
2300013	PA2019510,C2300013	Lithuania	⤷ Sign Up	PRODUCT NAME: BRIGATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1264 20181122
2300013	132019000000069	Italy	⤷ Sign Up	PRODUCT NAME: BRIGATINIB, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ALUNBRIG); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1264, 20181126
2300013	C20190026 00287	Estonia	⤷ Sign Up	PRODUCT NAME: BRIGATINIIB;REG NO/DATE: EU/1/18/1264 26.11.2018
2300013	2019/031	Ireland	⤷ Sign Up	PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/18/1264 20181122
2300013	1990030-7	Sweden	⤷ Sign Up	PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1264 20181126
2300013	300990	Netherlands	⤷ Sign Up	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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