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:	67
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^: ⤷ Sign Up* 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
The Affiliated Hospital of Qingdao University	Phase 1
Qilu Pharmaceutical (Hainan) Co., Ltd.	Phase 3
Amicus CD LLC	Phase 2/Phase 3

See all amisulpride clinical trials

Pharmacology for amisulpride

Drug Class	Dopamine-2 Receptor Antagonist
Mechanism of Action	Dopamine D2 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for amisulpride

N05AL	Benzamides
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for amisulpride

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Glossary

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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	⤷ 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	209510-001	Feb 26, 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

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Country	Patent Number	Title	Estimated Expiration
Japan	2013522181		⤷ Sign Up
San Marino	T201400126	Uso di amisulpride per il trattamento di nausea e vomito post-operatori	⤷ Sign Up
Denmark	2567690		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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