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Brexpiprazole - Generic Drug Details

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What are the generic drug sources for brexpiprazole and what is the scope of brexpiprazole patent protection?

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

Brexpiprazole has thirty-two patent family members in twenty-seven countries.

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

Summary for brexpiprazole

International Patents:	32
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	8
Suppliers / Packagers:	1
Bulk Api Vendors:	52
Clinical Trials:	51
Patent Applications:	76
DailyMed Link:	brexpiprazole at DailyMed

Pharmacology for brexpiprazole

Drug Class

Atypical Antipsychotic

Synonyms for brexpiprazole

2(1H)-Quinolinone, 7-(4-(4-benzo(b)thien-4-yl-1-piperazinyl)butoxy)-

2J3YBM1K8C

7-(4-(4-(1-Benzothiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2(1H)-one

7-(4-(4-(Benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2(1H)-one

7-[4-(4-benzo[b]thien-4-yl-1-piperazinyl)butoxy]- 2(1H)-Quinolinone

7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)-butoxy]-1H-quinolin-2-one

7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one

7-[4-(4-Benzo[b]thiophen-4-ylpiperazin-1-yl)butoxy]-1H-quinolin-2-one

7-[4-[4-(1-benzothiophen-4-yl)piperazin-1-yl]butoxy]-1H-quinolin-2-one

913611-97-9

AC-30404

AK171366

AKOS025291100

AX8306230

BC600277

BCP10218

BCP24077

Brexpiprazole (JAN/USAN/INN)

Brexpiprazole [USAN:INN]

Brexpiprazole; OPC-34712

Brexpiprazole.2H2O

Brexpiprazole(OPC34712)

CHEBI:134716

CHEMBL2105760

CS-2108

D10309

DB09128

DTXSID40238527

EX-A2639

FT-0712292

GTPL7672

HY-15780

KS-0000063N

MolPort-039-063-477

MolPort-046-033-502

NCGC00378574-02

OPC 34712

OPC-34712

OPC34712

Rexulti

Rexulti (TN)

Rxulti

s4639

SB16735

SCHEMBL1037592

SCHEMBL14772509

UNII-2J3YBM1K8C

ZINC84758479

ZKIAIYBUSXZPLP-UHFFFAOYSA-N

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	205422-005	Jul 10, 2015		RX	Yes	No			Y
Otsuka Pharm Co Ltd	REXULTI	brexpiprazole	TABLET;ORAL	205422-004	Jul 10, 2015		RX	Yes	Yes			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	205422-004	Jul 10, 2015		RX	Yes	Yes

International Patents for brexpiprazole

Country	Patent Number	Estimated Expiration
Cyprus	1111206
Taiwan	200716619
Lithuania	PA2018509
Israel	185909
Mexico	2007012626

Supplementary Protection Certificates for brexpiprazole

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1869025	LUC00086	Luxembourg		PRODUCT NAME: BREXPIPRAZOLE OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1869025	300946	Netherlands		PRODUCT NAME: BREXPIPRAZOLE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/18/1294 20180727
1869025	PA2018509	Lithuania		PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025	CA 2018 00028	Denmark		PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727
1869025	2018C/037	Belgium		PRODUCT NAME: BREXPIPRAZOL OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730