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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 four patents protecting this drug.

This drug has thirty-two patent family members in twenty-seven 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:	32
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	52
Clinical Trials:	4
Patent Applications:	54
Drug Prices:	Drug price information for REXULTI
Prior Art and Litigation Support	Order Prior Art and Litigation support for REXULTI
DailyMed Link:	REXULTI at DailyMed

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.

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

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

International Patents for REXULTI

Country	Patent Number	Estimated Expiration
Lithuania	PA2018509
Japan	4315393
Australia	2006237905

Supplementary Protection Certificates for REXULTI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1869025	PA2018509	Lithuania		PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025	300946	Netherlands		PRODUCT NAME: BREXPIPRAZOLE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/18/1294 20180727
1869025	CA 2018 00028	Denmark		PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727