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REXULTI Drug Profile

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Which patents cover Rexulti, and when can generic versions of Rexulti launch?

Rexulti is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. There are five patents protecting this drug.

This drug has fifty-nine patent family members in thirty-three countries.

The generic ingredient in REXULTI is brexpiprazole. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the brexpiprazole profile page.

Summary for REXULTI

International Patents:	59
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	55
Clinical Trials:	5
Patent Applications:	64
Drug Prices:	Drug price information for REXULTI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REXULTI
DailyMed Link:	REXULTI at DailyMed

See drug prices for REXULTI

Generic Entry Opportunity Date for REXULTI

NDA:

205422

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 REXULTI

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

Sponsor	Phase
Otsuka Pharmaceutical Co., Ltd.	Phase 2/Phase 3
Astellas Pharma Global Development, Inc.	Phase 2
University of Chicago	Phase 2

See all REXULTI clinical trials

Recent Litigation for REXULTI

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Otsuka Pharmaceutical Co., Ltd. v. Ajanta Pharma Ltd.	2019-10-11

See all REXULTI litigation

Pharmacology for REXULTI

Drug Class

Atypical Antipsychotic

Synonyms for REXULTI

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

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 (TN)

Rxulti

s4639

SB16735

SCHEMBL1037592

SCHEMBL14772509

UNII-2J3YBM1K8C

ZINC84758479

ZKIAIYBUSXZPLP-UHFFFAOYSA-N

Paragraph IV (Patent) Challenges for REXULTI

Tradename	Dosage	Ingredient	NDA	Submissiondate
REXULTI	TABLET;ORAL	brexpiprazole	205422	2019-07-10

US Patents and Regulatory Information for REXULTI

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	205422-004	Jul 10, 2015		RX	Yes	Yes
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	205422-004	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	205422-001	Jul 10, 2015		RX	Yes	No				Y
Otsuka Pharm Co Ltd	REXULTI	brexpiprazole	TABLET;ORAL	205422-003	Jul 10, 2015		RX	Yes	No				Y

International Patents for REXULTI

Country	Patent Number	Estimated Expiration
Mexico	2014004135
Singapore	10201608412S
Malaysia	142746
Brazil	112014008603
India	855DEN2012
South Korea	20140075754
South Korea	100937623

Supplementary Protection Certificates for REXULTI

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	PA2018509	Lithuania		PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025	CR 2018 00028	Denmark		PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727
1869025	1890028-2	Sweden		PRODUCT NAME: BREXPIPRAZOLE, OR A SALT THEREOF; REG. 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	122018000088	Germany		PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025	303 50013-2018	Slovakia		PRODUCT NAME: BREXPIPRAZOL VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1294 20180730