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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 sixty patent family members in thirty-four 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.

US ANDA Litigation and Generic Entry Outlook for Rexulti

Rexulti was eligible for patent challenges on July 10, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 12, 2032. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for REXULTI

International Patents:	60
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	57
Clinical Trials:	9
Patent Applications:	66
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 Development & Commercialization, Inc.	Phase 2/Phase 3
Queen's University	Phase 3
Baycrest	Phase 3

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
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	205422-001	Jul 10, 2015		RX	Yes	No			Y

International Patents for REXULTI

Country	Patent Number	Estimated Expiration
China	101155804
Lithuania	PA2018509
Russian Federation	2402549
Eurasian Patent Organization	032930
Japan	6084161
Brazil	PI0609785
Mexico	2014004135

Supplementary Protection Certificates for REXULTI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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