BREXPIPRAZOLE - Generic Drug Details

What are the generic drug 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. Three 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:	3
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	73
Patent Applications:	641
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
Unity Health Toronto	Phase 4

See all BREXPIPRAZOLE clinical trials

Generic filers with tentative approvals for BREXPIPRAZOLE

Applicant	Application No.	Strength	Dosage Form
		2MG	TABLET;ORAL
		1MG	TABLET;ORAL
		0.5MG	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

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	213782-004	Nov 28, 2023		DISCN	No	No
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-002	Jul 10, 2015		RX	Yes	No					Y
Sandoz	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213570-001	Sep 26, 2022		DISCN	No	No
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-003	Jul 10, 2015		RX	Yes	No
Lupin Ltd	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213512-006	Mar 17, 2023		DISCN	No	No
Teva Pharms Usa Inc	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213692-006	Aug 11, 2022		DISCN	No	No

EU/EMA Drug Approvals for BREXPIPRAZOLE

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

International Patents for BREXPIPRAZOLE

Country	Patent Number	Title	Estimated Expiration
Lithuania	PA2018509
World Intellectual Property Organization (WIPO)	2013054872
World Intellectual Property Organization (WIPO)	2006112464
Ukraine	114411	ТАБЛЕТКА, ЩО МІСТИТЬ 7-[4-(4-БЕНЗО[b]ТІОФЕН-4-ІЛ-ПІПЕРАЗИН-1-ІЛ)БУТОКСИ]-1H-ХІНОЛІН-2-ОН АБО ЙОГО СІЛЬ (TABLET INCLUDING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF)
China	103889425	TABLET INCLUDING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF
Hong Kong	1112236	PIPERAZINE-SUBSTITUTED BENZOTHIOPHENES FOR TREATMENT OF MENTAL DISORDERS

Supplementary Protection Certificates for BREXPIPRAZOLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1869025	C20180022 00264	Estonia		PRODUCT NAME: BREKSPIPRASOOL;REG NO/DATE: EU/1/18/1294 30.07.2018
1869025	303 50013-2018	Slovakia		PRODUCT NAME: BREXPIPRAZOL VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1869025	32/2018	Austria		PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 (MITTEILUNG) 20180727
1869025	CR 2018 00028	Denmark		PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727
1869025	122018000088	Germany		PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025	PA2018509	Lithuania		PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726