➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKesson
Medtronic
Colorcon
Baxter
AstraZeneca
Express Scripts

Last Updated: May 31, 2020

DrugPatentWatch Database Preview

Brexpiprazole - Generic Drug Details

» See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for brexpiprazole and what is the scope of freedom to operate?

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

Brexpiprazole has sixty-nine patent family members in thirty-six countries.

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

Recent Clinical Trials for brexpiprazole

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

SponsorPhase
Otsuka Pharmaceutical Development & Commercialization, Inc.Phase 2/Phase 3
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2
University of Colorado, DenverPhase 2

See all brexpiprazole clinical trials

Recent Litigation for brexpiprazole

Identify potential future generic entrants

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

See all brexpiprazole litigation

Pharmacology for brexpiprazole
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
A13527
AC-30404
AK171366
AKOS025291100
AS-56467
AX8306230
BCP10218
BCP24077
Brexpiprazole (JAN/USAN/INN)
Brexpiprazole [USAN:INN]
Brexpiprazole; OPC-34712
Brexpiprazole.2H2O
Brexpiprazole(OPC34712)
CHEBI:134716
CHEMBL2105760
CS-2108
D10309
DA-35913
DB09128
DTXSID40238527
EX-A2639
FT-0712292
GTPL7672
HY-15780
KS-0000063N
NCGC00378574-02
OPC 34712
OPC-34712
OPC34712
Q2924764
Rexulti
Rexulti (TN)
Rxulti
s4639
SB16735
SCHEMBL1037592
SCHEMBL14772509
UNII-2J3YBM1K8C
ZINC000084758479
ZINC84758479
ZKIAIYBUSXZPLP-UHFFFAOYSA-N
Paragraph IV (Patent) Challenges for BREXPIPRAZOLE
Tradename Dosage Ingredient NDA Submissiondate
REXULTI TABLET;ORAL brexpiprazole 205422 2019-07-10

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 205422-005 Jul 10, 2015 RX Yes No   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
Otsuka Pharm Co Ltd REXULTI brexpiprazole TABLET;ORAL 205422-006 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
>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 brexpiprazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1869025 32/2018 Austria   Start Trial PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 (MITTEILUNG) 20180727
1869025 303 50013-2018 Slovakia   Start Trial PRODUCT NAME: BREXPIPRAZOL VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1869025 LUC00086 Luxembourg   Start Trial PRODUCT NAME: BREXPIPRAZOLE OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1869025 1890028-2 Sweden   Start Trial PRODUCT NAME: BREXPIPRAZOLE, OR A SALT THEREOF; REG. NO/DATE: EU/1/18/1294 20180730
>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:

McKesson
Medtronic
Colorcon
Baxter
AstraZeneca
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 verification 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.