Brexpiprazole - Generic Drug Details

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What are the generic sources for brexpiprazole and what is the scope of freedom to operate?

Brexpiprazole is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Anda Repository, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Lupin Ltd, Sandoz, Teva Pharms Usa Inc, Zydus Pharms, and Otsuka, and is included in eleven NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brexpiprazole has seventy-four patent family members in thirty-seven countries.

There are eight drug master file entries for brexpiprazole. Four suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for brexpiprazole

International Patents:	74
US Patents:	6
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	73
Patent Applications:	647
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for brexpiprazole
What excipients (inactive ingredients) are in brexpiprazole?	brexpiprazole excipients list
DailyMed Link:	brexpiprazole at DailyMed

Recent Clinical Trials for brexpiprazole

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

Sponsor	Phase
H. Lundbeck A/S	Phase 4
Iqvia Pty Ltd	Phase 1
Baycrest	Phase 4

See all brexpiprazole clinical trials

Generic filers with tentative approvals for BREXPIPRAZOLE

Applicant	Application No.	Strength	Dosage Form
⤷ Subscribe	⤷ Subscribe	4MG	TABLET;ORAL
⤷ Subscribe	⤷ Subscribe	3MG	TABLET;ORAL
⤷ Subscribe	⤷ Subscribe	2MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for brexpiprazole

Drug Class	Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for brexpiprazole

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for BREXPIPRAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REXULTI	Tablets	brexpiprazole	0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg	205422	18	2019-07-10

US Patents and Regulatory Information for brexpiprazole

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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
Alkem Labs Ltd	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213782-002	Nov 28, 2023		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-004	Jul 10, 2015		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Alkem Labs Ltd	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213782-003	Nov 28, 2023		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Alkem Labs Ltd	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213782-001	Nov 28, 2023		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Teva Pharms Usa Inc	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213692-005	Aug 11, 2022		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Ajanta Pharma Ltd	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213718-006	Feb 3, 2023		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Lupin Ltd	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213512-002	Mar 17, 2023		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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 brexpiprazole

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Otsuka Pharmaceutical Netherlands B.V.	Rxulti	brexpiprazole	EMEA/H/C/003841 Treatment of schizophrenia.	Authorised	no	no	no	2018-07-26
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for brexpiprazole

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Country	Patent Number	Title	Estimated Expiration
Chile	2014000909	Una tableta que comprende 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoxi]-1h-quinolin-2-ona o una sal de ella como ingrediente activo; y metodo para producirla.	⤷ Subscribe
China	103889425	TABLET INCLUDING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF	⤷ Subscribe
Canada	2602247	BENZOTHIOPHENES A SUBSTITUANT PIPERAZINE POUR LE TRAITEMENT DE TROUBLES MENTAUX (PIPERAZINE-SUBSTITUTED BENZOTHIOPHENES FOR TREATMENT OF MENTAL DISORDERS)	⤷ Subscribe
Canada	2851588	COMPRIME COMPRENANT DE LA 7-[4-(4-BENZO[B]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OU UN SEL DE CELLE-CI (TABLET COMPRISING 7-[4-(4-BENZO[B]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXYL)-1H-QUINOLIN-2-ONE OR A SALT THEREOF)	⤷ Subscribe
Singapore	2014013783	TABLET COMPRISING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF	⤷ Subscribe
Brazil	112014008603	tablete, e, método para produzir um tablete	⤷ Subscribe
Spain	2358631		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for brexpiprazole

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1869025	CR 2018 00028	Denmark	⤷ Subscribe	PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727
1869025	303 50013-2018	Slovakia	⤷ Subscribe	PRODUCT NAME: BREXPIPRAZOL VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1869025	2018C/037	Belgium	⤷ Subscribe	PRODUCT NAME: BREXPIPRAZOL OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1869025	32/2018	Austria	⤷ Subscribe	PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 (MITTEILUNG) 20180727
1869025	C20180022 00264	Estonia	⤷ Subscribe	PRODUCT NAME: BREKSPIPRASOOL;REG NO/DATE: EU/1/18/1294 30.07.2018
1869025	LUC00086	Luxembourg	⤷ Subscribe	PRODUCT NAME: BREXPIPRAZOLE OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1869025	122018000088	Germany	⤷ Subscribe	PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 20180726
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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