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Brexpiprazole - Generic Drug Details
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What are the generic sources for brexpiprazole and what is the scope of freedom to operate?
Brexpiprazole
is the generic ingredient in one branded drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Brexpiprazole has seventy patent family members in thirty-six countries.
There are eight drug master file entries for brexpiprazole. One supplier is listed for this compound.
Summary for brexpiprazole
International Patents: | 70 |
US Patents: | 6 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 8 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 62 |
Clinical Trials: | 65 |
Patent Applications: | 322 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for brexpiprazole |
DailyMed Link: | brexpiprazole at DailyMed |
Recent Clinical Trials for brexpiprazole
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Douglas Mental Health University Institute | Phase 3 |
Jewish General Hospital | Phase 3 |
University of Colorado, Denver | Phase 2 |
Pharmacology for brexpiprazole
Drug Class | Atypical Antipsychotic |
Paragraph IV (Patent) Challenges for BREXPIPRAZOLE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
REXULTI | TABLET;ORAL | brexpiprazole | 205422 | 2019-07-10 |
US Patents and Regulatory Information for brexpiprazole
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Otsuka Pharm Co Ltd | REXULTI | brexpiprazole | TABLET;ORAL | 205422-006 | Jul 10, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Otsuka Pharm Co Ltd | REXULTI | brexpiprazole | TABLET;ORAL | 205422-002 | Jul 10, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Otsuka Pharm Co Ltd | REXULTI | brexpiprazole | TABLET;ORAL | 205422-002 | Jul 10, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Otsuka Pharm Co Ltd | REXULTI | brexpiprazole | TABLET;ORAL | 205422-003 | Jul 10, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Otsuka Pharm Co Ltd | REXULTI | brexpiprazole | TABLET;ORAL | 205422-005 | Jul 10, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Otsuka Pharm Co Ltd | REXULTI | brexpiprazole | TABLET;ORAL | 205422-003 | Jul 10, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for brexpiprazole
Country | Patent Number | Estimated Expiration |
---|---|---|
Slovenia | 1869025 | Start Trial |
World Intellectual Property Organization (WIPO) | 2013054872 | Start Trial |
Hong Kong | 1112236 | Start Trial |
South Korea | 100937623 | Start Trial |
European Patent Office | 2767285 | Start Trial |
Denmark | 2767285 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for brexpiprazole
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1869025 | 18C0004 | France | Start Trial | PRODUCT NAME: BREXPIPRAZOLE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/18/1294 20180730 |
1869025 | 1890028-2 | Sweden | Start Trial | PRODUCT NAME: BREXPIPRAZOLE, OR A SALT THEREOF; REG. NO/DATE: EU/1/18/1294 20180730 |
1869025 | PA2018509,C1869025 | Lithuania | Start Trial | PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726 |
1869025 | 2018C/037 | Belgium | Start Trial | PRODUCT NAME: BREXPIPRAZOL OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730 |
1869025 | C01869025/01 | Switzerland | Start Trial | PRODUCT NAME: BREXPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66475 17.07.2018 |
1869025 | LUC00086 | Luxembourg | Start 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 |
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