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Last Updated: July 16, 2024

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-four patent family members in thirty-seven countries.

The generic ingredient in REXULTI is brexpiprazole. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the brexpiprazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Rexulti

A generic version of REXULTI was approved as brexpiprazole by OPTIMUS on October 25th, 2023.

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Drug patent expirations by year for REXULTI
Drug Prices for REXULTI

See drug prices for REXULTI

Recent Clinical Trials for REXULTI

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

SponsorPhase
Dalhousie UniversityPhase 4
University of MichiganPhase 4
Unity Health TorontoPhase 4

See all REXULTI clinical trials

Pharmacology 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 two FDA Regulatory Exclusivities.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA

Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA

Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting REXULTI

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
Exclusivity Expiration: ⤷  Sign Up

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 205422-004 Jul 10, 2015 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-003 Jul 10, 2015 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-005 Jul 10, 2015 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-005 Jul 10, 2015 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-003 Jul 10, 2015 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Patent: COMPRIMIDO QUE COMPRENDE 7-[4-(4-BENZO[B]TIOFEN-4-IL-PIPERACIN-1-IL)BUTOXI]-1H-QUINOLIN-2-ONA O UNA DE SUS SALES
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 12321723
Patent: Tablet including 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl) butoxy]-1H-quinolin-2-one or salt thereof
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2014008603
Patent: tablete, e, método para produzir um tablete
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 51588
Patent: COMPRIME COMPRENANT DE LA 7-[4-(4-BENZO[B]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OU UN SEL DE CELLE-CI (TABLET COMPRISING 7-[4-(4-BENZO[B]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXYL)-1H-QUINOLIN-2-ONE OR A SALT THEREOF)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 14000909
Patent: Una tableta que comprende 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoxi]-1h-quinolin-2-ona o una sal de ella como ingrediente activo; y metodo para producirla.
Estimated Expiration: ⤷  Sign Up

China

Patent: 3889425
Patent: TABLET INCLUDING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF
Estimated Expiration: ⤷  Sign Up

Patent: 7397730
Patent: 含有7‑[4‑(4‑苯并[b]噻吩‑4‑基‑哌嗪‑1‑基)丁氧基]‑1H‑喹啉‑2‑酮或其盐的片剂 (TABLET INCLUDING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF)
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 50480
Patent: Tableta que contiene 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoxi]-1h-quinolin-2-ona o una de sus sales
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0200037
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 22460
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 67285
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 2930
Patent: ТАБЛЕТКА, ВКЛЮЧАЮЩАЯ В СЕБЯ 7-[4-(4-БЕНЗО[b]ТИОФЕН-4-ИЛ-ПИПЕРАЗИН-1-ИЛ)БУТОКСИ]-1Н-ХИНОЛИН-2-ОН ИЛИ ЕГО СОЛЬ (TABLET COMPRISING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR A SALT THEREOF)
Estimated Expiration: ⤷  Sign Up

Patent: 1490783
Patent: ТАБЛЕТКА, ВКЛЮЧАЮЩАЯ В СЕБЯ 7-[4-(4-БЕНЗО[b]ТИОФЕН-4-ИЛ-ПИПЕРАЗИН-1-ИЛ)БУТОКСИ]-1Н-ХИНОЛИН-2-ОН ИЛИ ЕГО СОЛЬ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 67285
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 47493
Estimated Expiration: ⤷  Sign Up

India

Patent: 55DEN2014
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 1513
Patent: טבליה הכוללת 7-[4-(4-בנזו[b]תיאופן-4-איל-פיפראזין-1-איל)בוטוקסי]-1h-קינולין-2-און או מלח שלו (Tablet comprising 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1h-quinolin-2-one or salt thereof)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 2013054872
Patent: 7−[4−(4−ベンゾ[b]チオフェン−4−イル−ピペラジン−1−イル)ブトキシ]−1H−キノリン−2−オン又はその塩を含む錠剤
Estimated Expiration: ⤷  Sign Up

Patent: 84161
Estimated Expiration: ⤷  Sign Up

Patent: 17088610
Patent: 7−[4−(4−ベンゾ[b]チオフェン−4−イル−ピペラジン−1−イル)ブトキシ]−1H−キノリン−2−オン又はその塩を含む錠剤 (TABLET CONTAINING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF)
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 53
Patent: قرص يتألف من 7-[4-(4-بينزو[بي]ثيوفين-4-ايل-ببرازين-1-1ايل)بوتكسيل]-1اتش-كوينولين-2-وان أو ملح منه (Tablet comprising 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 67285
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 3370
Patent: TABLET COMPRISING 7-[4-(4-BENZO[B]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR A SALT THEREOF
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 14004135
Patent: TABLETA QUE COMPRENDE 7-[4-(4-BENZO[B]TIOFEN-4-IL-PIPERAZIN-1-IL)B UTOXI]-1H-QUINOLIN-2-ONA O SAL DE LA MISMA. (TABLET INCLUDING 7-[4-(4-BENZO[ï1⁄2 ]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 2639
Patent: Tablet comprising 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl) butoxy]-1h-quinolin-2-one or a salt thereof
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 67285
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 67285
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 14013783
Patent: TABLET COMPRISING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF
Estimated Expiration: ⤷  Sign Up

Patent: 201608412S
Patent: TABLET COMPRISING 7-[4-(4-BENZO[ b ]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR A SALT THEREOF
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 67285
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1402333
Patent: TABLET INCLUDING 7-[4-(4-BENZO[B]THIOPHEN-4-YL-PIPERAZIN -1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2072371
Estimated Expiration: ⤷  Sign Up

Patent: 140075754
Patent: TABLET INCLUDING 7-[4-(4-BENZO[B]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 62479
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 34908
Estimated Expiration: ⤷  Sign Up

Patent: 1318651
Patent: Tablet comprising 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 4411
Patent: ТАБЛЕТКА, ЩО МІСТИТЬ 7-[4-(4-БЕНЗО[b]ТІОФЕН-4-ІЛ-ПІПЕРАЗИН-1-ІЛ)БУТОКСИ]-1H-ХІНОЛІН-2-ОН АБО ЙОГО СІЛЬ (TABLET INCLUDING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF)
Estimated Expiration: ⤷  Sign Up

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
Australia 2012321723 Tablet including 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl) butoxy]-1H-quinolin-2-one or salt thereof ⤷  Sign Up
Malaysia 173370 TABLET COMPRISING 7-[4-(4-BENZO[B]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR A SALT THEREOF ⤷  Sign Up
Lithuania C1869025 ⤷  Sign Up
Mexico 2014004135 TABLETA QUE COMPRENDE 7-[4-(4-BENZO[B]TIOFEN-4-IL-PIPERAZIN-1-IL)B UTOXI]-1H-QUINOLIN-2-ONA O SAL DE LA MISMA. (TABLET INCLUDING 7-[4-(4-BENZO[ï1⁄2 ]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF.) ⤷  Sign Up
India 855DEN2012 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for REXULTI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1869025 122018000088 Germany ⤷  Sign Up PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025 PA2018509,C1869025 Lithuania ⤷  Sign Up PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025 SPC/GB18/038 United Kingdom ⤷  Sign Up PRODUCT NAME: BREXPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/18/1294/001(NI) 20180730; UK PLGB 506970019 20180730; UK PLGB 506970020 20180730; UK PLGB 506970021 20180730; UK PLGB 506970022 20180730; UK PLGB 506970023 20180730; UK EU/1/18/1294/007(NI) 20180730; UK EU/1/18/1294/008(NI) 20180730; UK EU/1/18/1294/009(NI) 20180730; UK EU/1/18/1294/010(NI) 20180730; UK EU/1/18/1294/011(NI) 20180730; UK PLGB 506970024 20180730; UK EU/1/18/1294/002(NI) 20180730; UK EU/1/18/1294/003(NI) 20180730; UK EU/1/18/1294/004(NI) 20180730; UK EU/1/18/1294/005(NI) 20180730; UK EU/1/18/1294/006(NI) 20180730
1869025 2018C/037 Belgium ⤷  Sign Up PRODUCT NAME: BREXPIPRAZOL OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1869025 LUC00086 Luxembourg ⤷  Sign Up PRODUCT NAME: BREXPIPRAZOLE OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
>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.