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-five patent family members in twenty-six countries.

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

Summary for amisulpride

International Patents:	65
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	132
Clinical Trials:	65
Patent Applications:	6,272
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
Amicus CD LLC	Phase 2/Phase 3
Acacia Pharma Ltd	Phase 2/Phase 3
Premier Research Group plc	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	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-002	Sep 1, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-002	Sep 1, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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
Hungary	E037088		See Plans and Pricing
Hong Kong	1179152	氨磺必利用於製備治療噁心、嘔吐和反胃的病症的藥劑的用途 (THE USE OF AMISULPRIDE FOR PRODUCING AN AGENT IN THE THERAPY OF NAUSEA, VOMITING AND RETCHES)	See Plans and Pricing
Serbia	57032	UPOTREBA AMISULPRIDA ZA TRETIRANJE OPIJATOM INDUKOVANE MUČNINE I POVRAĆANJA (USE OF AMISULPRIDE FOR TREATING OPIATED-INDUCED NAUSEA AND VOMITING)	See Plans and Pricing
Croatia	P20140745		See Plans and Pricing
European Patent Office	2796171	Utilisation de l'amisulpride pour le traitement des nausées et vomissements induits par les opiacés (Use of amisulpride for treating opiated-induced nausea and vomiting)	See Plans and Pricing
Japan	2020506209	術後悪心嘔吐の救急治療	See Plans and Pricing
Spain	2496099		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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