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Last Updated: August 8, 2022

REXULTI Drug Patent Profile


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When do Rexulti patents expire, and when can generic versions of Rexulti launch?

Rexulti is a drug marketed by Otsuka and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-two patent family members in thirty-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.

DrugPatentWatch® 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 have been twenty-one patent litigation cases 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.

There are four tentative approvals for the generic drug (brexpiprazole), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for REXULTI
Drug Prices for REXULTI

See drug prices for REXULTI

DrugPatentWatch® Estimated 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
Simon Fraser UniversityPhase 4
McGill UniversityPhase 4
University of OttawaPhase 4

See all REXULTI clinical trials

Pharmacology for REXULTI
Anatomical Therapeutic Chemical (ATC) Classes for REXULTI
Paragraph IV (Patent) Challenges for REXULTI
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
REXULTI Tablets brexpiprazole 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg 205422 18 2019-07-10

US Patents and Regulatory Information for REXULTI

REXULTI is protected by nine US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of REXULTI is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting REXULTI

Tablet comprising 7-[4-(4-benzo[b]thiopen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA IN ADULTS AND PEDIATRIC PATIENTS AGES 13 YEARS AND OLDER

Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA IN ADULTS AND PEDIATRIC PATIENTS AGES 13 YEARS AND OLDER

Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting REXULTI

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-005 Jul 10, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-004 Jul 10, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-005 Jul 10, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for REXULTI

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Otsuka Pharmaceutical Netherlands B.V. Rxulti brexpiprazole EMEA/H/C/003841
Treatment of schizophrenia.
Authorised no no no 2018-07-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for REXULTI

When does loss-of-exclusivity occur for REXULTI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 8319
Estimated Expiration: See Plans and Pricing

Australia

Patent: 12321723
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2014008603
Estimated Expiration: See Plans and Pricing

Canada

Patent: 51588
Estimated Expiration: See Plans and Pricing

Chile

Patent: 14000909
Estimated Expiration: See Plans and Pricing

China

Patent: 3889425
Estimated Expiration: See Plans and Pricing

Patent: 7397730
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 50480
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0200037
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 67285
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 2930
Estimated Expiration: See Plans and Pricing

Patent: 1490783
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 67285
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 47493
Estimated Expiration: See Plans and Pricing

India

Patent: 55DEN2014
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1513
Estimated Expiration: See Plans and Pricing

Japan

Patent: 2013054872
Estimated Expiration: See Plans and Pricing

Patent: 84161
Estimated Expiration: See Plans and Pricing

Patent: 17088610
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 53
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 67285
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 3370
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 14004135
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2639
Estimated Expiration: See Plans and Pricing

Poland

Patent: 67285
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 67285
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 14013783
Estimated Expiration: See Plans and Pricing

Patent: 201608412S
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 67285
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1402333
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2072371
Estimated Expiration: See Plans and Pricing

Patent: 140075754
Estimated Expiration: See Plans and Pricing

Spain

Patent: 62479
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 34908
Estimated Expiration: See Plans and Pricing

Patent: 1318651
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 4411
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering REXULTI around the world.

Country Patent Number Title Estimated Expiration
Singapore 2014013783 TABLET COMPRISING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF See Plans and Pricing
European Patent Office 2767285 COMPRIMÉ COMPRENANT DE LA 7-[4-(4-BENZO[b]THIOPHÉN-4-YL-PIPÉRAZIN-1-YL) BUTOXY]-1H-QUINOLÉIN-2-ONE OU UN SEL DE CELLE-CI (TABLET COMPRISING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR A SALT THEREOF) See Plans and Pricing
Mexico 2007012626 BENZOTIOFENOS SUSTITUIDOS CON PIPERAZINA PARA EL TRATAMIENTO DE TRASTORNOS MENTALES. (PIPERAZINE-SUBSTITUTED BENZOTHIOPHENES FOR TREATMENT OF MENTAL DISORDERS.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for REXULTI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1869025 18C0004 France See Plans and Pricing PRODUCT NAME: BREXPIPRAZOLE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1869025 LUC00086 Luxembourg See Plans and Pricing PRODUCT NAME: BREXPIPRAZOLE OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1869025 CR 2018 00028 Denmark See Plans and Pricing PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.