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. Four 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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Questions you can ask:
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Summary for REXULTI
International Patents: | 74 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 80 |
Clinical Trials: | 11 |
Patent Applications: | 322 |
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 |
---|---|
University of Ottawa | Phase 4 |
McGill University | Phase 4 |
University of British Columbia | 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.
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 | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Otsuka | REXULTI | brexpiprazole | TABLET;ORAL | 205422-003 | Jul 10, 2015 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Otsuka | REXULTI | brexpiprazole | TABLET;ORAL | 205422-005 | Jul 10, 2015 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Otsuka | REXULTI | brexpiprazole | TABLET;ORAL | 205422-006 | Jul 10, 2015 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Otsuka | REXULTI | brexpiprazole | TABLET;ORAL | 205422-005 | Jul 10, 2015 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Otsuka | REXULTI | brexpiprazole | TABLET;ORAL | 205422-005 | Jul 10, 2015 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
>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: ⤷ Subscribe
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: ⤷ Subscribe
Brazil
Patent: 2014008603
Patent: tablete, e, método para produzir um tablete
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Croatia
Patent: 0200037
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 22460
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 67285
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Hungary
Patent: 47493
Estimated Expiration: ⤷ Subscribe
India
Patent: 55DEN2014
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Patent: 84161
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Lithuania
Patent: 67285
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Poland
Patent: 67285
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 67285
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Slovenia
Patent: 67285
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
South Korea
Patent: 2072371
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Spain
Patent: 62479
Estimated Expiration: ⤷ Subscribe
Taiwan
Patent: 34908
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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 |
---|---|---|---|
Canada | 2851588 | 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) | ⤷ Subscribe |
Cyprus | 1122460 | ⤷ Subscribe | |
Malaysia | 173370 | TABLET COMPRISING 7-[4-(4-BENZO[B]THIOPHEN-4-YL-PIPERAZIN-1-YL)BUTOXY]-1H-QUINOLIN-2-ONE OR A SALT THEREOF | ⤷ Subscribe |
Poland | 1869025 | ⤷ Subscribe | |
Denmark | 2767285 | ⤷ Subscribe | |
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.) | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for REXULTI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1869025 | 32/2018 | Austria | ⤷ Subscribe | PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 (MITTEILUNG) 20180727 |
1869025 | 1890028-2 | Sweden | ⤷ Subscribe | PRODUCT NAME: BREXPIPRAZOLE, OR A SALT THEREOF; REG. NO/DATE: EU/1/18/1294 20180730 |
1869025 | 2018/034 | Ireland | ⤷ Subscribe | PRODUCT NAME: BREXPIPRAZOLE OR A SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/18/1294 20180726; FIRST REGISTRATION NO/DATE: JOURNAL OF THE INTELLECTUAL PROPERTY OFFICE OF IRELAND (NO. 2402) |
1869025 | 122018000088 | Germany | ⤷ Subscribe | PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 20180726 |
1869025 | PA2018509 | Lithuania | ⤷ Subscribe | PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726 |
1869025 | C201830050 | Spain | ⤷ Subscribe | PRODUCT NAME: BREXPIPRAZOL O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1294; DATE OF AUTHORISATION: 20180726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1294; DATE OF FIRST AUTHORISATION IN EEA: 20180726 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
REXULTI Market Analysis and Financial Projection Experimental
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