REXULTI Drug Patent Profile
✉ Email this page to a colleague
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® Litigation and Generic Entry Outlook for Rexulti
A generic version of REXULTI was approved as brexpiprazole by AJANTA PHARMA LTD on February 3rd, 2023.
Summary for REXULTI
International Patents: | 74 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 79 |
Clinical Trials: | 11 |
Patent Applications: | 93 |
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 |
---|---|
McGill University | Phase 4 |
University of Ottawa | Phase 4 |
Baycrest | Phase 4 |
Pharmacology for REXULTI
Drug Class | Atypical Antipsychotic |
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 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA
Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA
Piperazine-substituted benzothiophenes for treatment of mental disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting REXULTI
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Otsuka | REXULTI | brexpiprazole | TABLET;ORAL | 205422-003 | Jul 10, 2015 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Otsuka | REXULTI | brexpiprazole | TABLET;ORAL | 205422-005 | Jul 10, 2015 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
>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: ⤷ Try a Trial
Australia
Patent: 12321723
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2014008603
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 51588
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 14000909
Estimated Expiration: ⤷ Try a Trial
China
Patent: 3889425
Estimated Expiration: ⤷ Try a Trial
Patent: 7397730
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 50480
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0200037
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 22460
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 67285
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 2930
Estimated Expiration: ⤷ Try a Trial
Patent: 1490783
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 67285
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 47493
Estimated Expiration: ⤷ Try a Trial
India
Patent: 55DEN2014
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 1513
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 2013054872
Estimated Expiration: ⤷ Try a Trial
Patent: 84161
Estimated Expiration: ⤷ Try a Trial
Patent: 17088610
Estimated Expiration: ⤷ Try a Trial
Jordan
Patent: 53
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 67285
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 3370
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 14004135
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 2639
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 67285
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 67285
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 14013783
Estimated Expiration: ⤷ Try a Trial
Patent: 201608412S
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 67285
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1402333
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2072371
Estimated Expiration: ⤷ Try a Trial
Patent: 140075754
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 62479
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 34908
Estimated Expiration: ⤷ Try a Trial
Patent: 1318651
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 4411
Estimated Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | |
Japan | 4315393 | ⤷ Try a Trial | |
Germany | 602006019838 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for REXULTI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1869025 | C 2018 036 | Romania | ⤷ Try a Trial | PRODUCT NAME: BREXPIPRAZOL SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1294; DATE OF NATIONAL AUTHORISATION: 20180726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1294; DATE OF FIRST AUTHORISATION IN EEA: 20180726 |
1869025 | CA 2018 00028 | Denmark | ⤷ Try a Trial | PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727 |
1869025 | LUC00086 | Luxembourg | ⤷ Try a Trial | 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 |