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Last Updated: November 5, 2024

Amisulpride - Generic Drug Details


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What are the generic sources for amisulpride and what is the scope of patent protection?

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

Amisulpride has sixty-eight patent family members in twenty-seven countries.

There are four drug master file entries for amisulpride. One supplier is listed for this compound.

Summary for amisulpride
International Patents:68
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 4
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 141
Clinical Trials: 67
Patent Applications: 6,356
What excipients (inactive ingredients) are in amisulpride?amisulpride excipients list
DailyMed Link:amisulpride at DailyMed
Recent Clinical Trials for amisulpride

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

SponsorPhase
The Affiliated Hospital of Qingdao UniversityPhase 1
Qilu Pharmaceutical (Hainan) Co., Ltd.Phase 3
Amicus CD LLCPhase 2/Phase 3

See all amisulpride clinical trials

Pharmacology for amisulpride
Anatomical Therapeutic Chemical (ATC) Classes for amisulpride

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Acacia BARHEMSYS amisulpride SOLUTION;INTRAVENOUS 209510-002 Sep 1, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Acacia BARHEMSYS amisulpride SOLUTION;INTRAVENOUS 209510-002 Sep 1, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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