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Last Updated: April 13, 2024

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 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: 66
Patent Applications: 6,356
What excipients (inactive ingredients) are in amisulpride?amisulpride excipients list
DailyMed Link:amisulpride at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for amisulpride
Generic Entry Date for amisulpride*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for amisulpride

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

SponsorPhase
Qilu Pharmaceutical (Hainan) Co., Ltd.Phase 3
Premier Research Group plcPhase 2/Phase 3
Amicus CD LLCPhase 2/Phase 3

See all amisulpride clinical trials

Pharmacology 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 209510-002 Sep 1, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Acacia BARHEMSYS amisulpride SOLUTION;INTRAVENOUS 209510-002 Sep 1, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Acacia BARHEMSYS amisulpride SOLUTION;INTRAVENOUS 209510-002 Sep 1, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Acacia BARHEMSYS amisulpride SOLUTION;INTRAVENOUS 209510-001 Feb 26, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Acacia BARHEMSYS amisulpride SOLUTION;INTRAVENOUS 209510-002 Sep 1, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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

International Patents for amisulpride

Country Patent Number Title Estimated Expiration
Japan 7333269 ⤷  Try a Trial
Japan 2023027213 術後悪心嘔吐の救援治療 ⤷  Try a Trial
Serbia 53466 UPOTREBA AMISULPRIDA ZA TRETIRANJE POSTOPERATIVNE MUČNINE I POVRAĆANJA (USE OF AMISULPRIDE FOR TREATING POST-OPERATIVE NAUSEA AND VOMITING) ⤷  Try a Trial
Spain 2496092 ⤷  Try a Trial
European Patent Office 2544657 Utilisation de l'amisulpride pour le traitement des nausées et vomissements postopératoires (Use of amisulpride for treating post-operative nausea and vomiting) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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