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
Sponsor | Phase |
---|---|
The Affiliated Hospital of Qingdao University | Phase 1 |
Qilu Pharmaceutical (Hainan) Co., Ltd. | Phase 3 |
Amicus CD LLC | Phase 2/Phase 3 |
Pharmacology for amisulpride
Drug Class | Dopamine-2 Receptor Antagonist |
Mechanism of Action | Dopamine D2 Antagonists |
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 |
International Patents for amisulpride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 201905212 | RESCUE TREATMENT OF POST OPERATIVE NAUSEA AND VOMITING | ⤷ Sign Up |
Spain | 2665418 | ⤷ Sign Up | |
Brazil | 112012022746 | uso de amissulprida como anti-emético | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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