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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 one branded drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brexpiprazole has seventy patent family members in thirty-six countries.

There are eight drug master file entries for brexpiprazole. One supplier is listed for this compound.

Summary for brexpiprazole

International Patents:	70
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	8
Suppliers / Packagers:	1
Bulk Api Vendors:	62
Clinical Trials:	65
Patent Applications:	322
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for brexpiprazole
DailyMed Link:	brexpiprazole at DailyMed

Recent Clinical Trials for brexpiprazole

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

Sponsor	Phase
Douglas Mental Health University Institute	Phase 3
Jewish General Hospital	Phase 3
University of Colorado, Denver	Phase 2

See all brexpiprazole clinical trials

Pharmacology for brexpiprazole

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for BREXPIPRAZOLE

Tradename	Dosage	Ingredient	NDA	Submissiondate
REXULTI	TABLET;ORAL	brexpiprazole	205422	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
Otsuka Pharm Co Ltd	REXULTI	brexpiprazole	TABLET;ORAL	205422-006	Jul 10, 2015		RX	Yes	No			Y
Otsuka Pharm Co Ltd	REXULTI	brexpiprazole	TABLET;ORAL	205422-002	Jul 10, 2015		RX	Yes	No
Otsuka Pharm Co Ltd	REXULTI	brexpiprazole	TABLET;ORAL	205422-002	Jul 10, 2015		RX	Yes	No				Y	Y
Otsuka Pharm Co Ltd	REXULTI	brexpiprazole	TABLET;ORAL	205422-003	Jul 10, 2015		RX	Yes	No				Y
Otsuka Pharm Co Ltd	REXULTI	brexpiprazole	TABLET;ORAL	205422-005	Jul 10, 2015		RX	Yes	No			Y
Otsuka Pharm Co Ltd	REXULTI	brexpiprazole	TABLET;ORAL	205422-003	Jul 10, 2015		RX	Yes	No

International Patents for brexpiprazole

Country	Patent Number	Estimated Expiration
Slovenia	1869025
World Intellectual Property Organization (WIPO)	2013054872
Hong Kong	1112236
South Korea	100937623
European Patent Office	2767285
Denmark	2767285

Supplementary Protection Certificates for brexpiprazole

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1869025	18C0004	France		PRODUCT NAME: BREXPIPRAZOLE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1869025	1890028-2	Sweden		PRODUCT NAME: BREXPIPRAZOLE, OR A SALT THEREOF; REG. NO/DATE: EU/1/18/1294 20180730
1869025	PA2018509,C1869025	Lithuania		PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025	2018C/037	Belgium		PRODUCT NAME: BREXPIPRAZOL OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1869025	C01869025/01	Switzerland		PRODUCT NAME: BREXPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66475 17.07.2018
1869025	LUC00086	Luxembourg		PRODUCT NAME: BREXPIPRAZOLE OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730