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Last Updated: September 28, 2020

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Amisulpride - Generic Drug Details

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What are the generic drug sources for amisulpride and what is the scope of freedom to operate?

Amisulpride is the generic ingredient in one branded drug marketed by Acacia and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amisulpride has fifty-one patent family members in twenty-six countries.

There are four drug master file entries for amisulpride.

Summary for amisulpride
International Patents:51
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 4
Bulk Api Vendors: 107
Clinical Trials: 56
Patent Applications: 3,568
DailyMed Link:amisulpride at DailyMed
Recent Clinical Trials for amisulpride

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

SponsorPhase
Shanghai Jiao Tong University School of MedicinePhase 4
Tianjin Anding HospitalN/A
Central South UniversityN/A

See all amisulpride clinical trials

US Patents and Regulatory Information for amisulpride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acacia BARHEMSYS amisulpride SOLUTION;INTRAVENOUS 209510-001 Feb 26, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
Acacia BARHEMSYS amisulpride SOLUTION;INTRAVENOUS 209510-001 Feb 26, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
Acacia BARHEMSYS amisulpride SOLUTION;INTRAVENOUS 209510-001 Feb 26, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Acacia BARHEMSYS amisulpride SOLUTION;INTRAVENOUS 209510-001 Feb 26, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
Acacia BARHEMSYS amisulpride SOLUTION;INTRAVENOUS 209510-001 Feb 26, 2020 RX Yes Yes   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

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Mallinckrodt
AstraZeneca
Moodys
Harvard Business School

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