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. Three suppliers are 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.
There have been twenty-four 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 five tentative approvals for the generic drug (brexpiprazole), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
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Summary for REXULTI
| International Patents: | 74 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 80 |
| Clinical Trials: | 11 |
| Patent Applications: | 319 |
| Drug Prices: | Drug price information for REXULTI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for REXULTI |
| What excipients (inactive ingredients) are in REXULTI? | REXULTI excipients list |
| DailyMed Link: | REXULTI at DailyMed |
Recent Clinical Trials for REXULTI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Simon Fraser University | Phase 4 |
| McGill University | Phase 4 |
| University of Ottawa | Phase 4 |
Pharmacology for REXULTI
| Drug Class | Atypical Antipsychotic |
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 six US patents and five 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
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
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
ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
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 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Otsuka | REXULTI | brexpiprazole | TABLET;ORAL | 205422-003 | Jul 10, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Otsuka | REXULTI | brexpiprazole | TABLET;ORAL | 205422-005 | Jul 10, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 |
|---|---|---|---|
| Lithuania | PA2018509 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2013054872 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2006112464 | ⤷ 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 | C20180022 00264 | Estonia | ⤷ Sign Up | PRODUCT NAME: BREKSPIPRASOOL;REG NO/DATE: EU/1/18/1294 30.07.2018 |
| 1869025 | 303 50013-2018 | Slovakia | ⤷ Sign Up | PRODUCT NAME: BREXPIPRAZOL VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1294 20180730 |
| 1869025 | 32/2018 | Austria | ⤷ Sign Up | PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 (MITTEILUNG) 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.
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