AMISULPRIDE - Generic Drug Details
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What are the generic 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
| Sponsor | Phase |
|---|---|
| Qilu Pharmaceutical (Hainan) Co., Ltd. | Phase 3 |
| Premier Research Group plc | Phase 2/Phase 3 |
| Amicus CD LLC | Phase 2/Phase 3 |
Pharmacology for AMISULPRIDE
| Drug Class | Dopamine-2 Receptor Antagonist |
| Mechanism of Action | Dopamine D2 Antagonists |
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 | 209510-001 | Feb 26, 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 | ⤷ Try a Trial | ||||
| Acacia | BARHEMSYS | amisulpride | SOLUTION;INTRAVENOUS | 209510-001 | Feb 26, 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 |
|---|---|---|---|
| Denmark | 2544657 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2011110854 | ⤷ Try a Trial | |
| Lithuania | 2796171 | ⤷ Try a Trial | |
| Brazil | 112019016565 | tratamento de emergência de náuseas e vômitos pós-operatórios | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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