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Last Updated: February 27, 2020

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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

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Drug patent expirations by year for REXULTI
Drug Prices for REXULTI

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Generic Entry Opportunity Date for REXULTI
Generic Entry Date for REXULTI*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Otsuka Pharmaceutical Development & Commercialization, Inc.Phase 2/Phase 3
Queen's UniversityPhase 3
BaycrestPhase 3

See all REXULTI clinical trials

Recent Litigation for REXULTI

Identify potential future generic entrants

District Court Litigation
Case NameDate
Otsuka Pharmaceutical Co., Ltd. v. Ajanta Pharma Ltd.2019-10-11

See all REXULTI litigation

Pharmacology for REXULTI
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   Start Trial   Start Trial Y   Start Trial
Otsuka Pharm Co Ltd REXULTI brexpiprazole TABLET;ORAL 205422-004 Jul 10, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Otsuka Pharm Co Ltd REXULTI brexpiprazole TABLET;ORAL 205422-006 Jul 10, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Otsuka Pharm Co Ltd REXULTI brexpiprazole TABLET;ORAL 205422-004 Jul 10, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Otsuka Pharm Co Ltd REXULTI brexpiprazole TABLET;ORAL 205422-005 Jul 10, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Otsuka Pharm Co Ltd REXULTI brexpiprazole TABLET;ORAL 205422-004 Jul 10, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Otsuka Pharm Co Ltd REXULTI brexpiprazole TABLET;ORAL 205422-001 Jul 10, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for REXULTI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1869025 1890028-2 Sweden   Start Trial PRODUCT NAME: BREXPIPRAZOLE, OR A SALT THEREOF; REG. NO/DATE: EU/1/18/1294 20180730
1869025 PA2018509,C1869025 Lithuania   Start Trial PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025 2018C/037 Belgium   Start Trial PRODUCT NAME: BREXPIPRAZOL OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1869025 C01869025/01 Switzerland   Start Trial PRODUCT NAME: BREXPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66475 17.07.2018
1869025 LUC00086 Luxembourg   Start Trial PRODUCT NAME: BREXPIPRAZOLE OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1869025 PA2018509 Lithuania   Start Trial PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025 300946 Netherlands   Start Trial PRODUCT NAME: BREXPIPRAZOLE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/18/1294 20180727
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
McKinsey
Boehringer Ingelheim
Harvard Business School
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.