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Last Updated: November 21, 2024

NIACIN Drug Patent Profile

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Which patents cover Niacin, and what generic alternatives are available?

Niacin is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Barr, Beijing, Chartwell Rx, Hibrow Hlthcare, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Rising, Sun Pharm, Yichang Humanwell, Everylife, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mk Labs, Purepac Pharm, Sandoz, Tablicaps, Watson Labs, and Wockhardt. and is included in thirty NDAs.

The generic ingredient in NIACIN is niacin. There are fourteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the niacin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Niacin

A generic version of NIACIN was approved as niacin by BARR on April 14^th, 2005.

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Summary for NIACIN

US Patents:	0
Applicants:	23
NDAs:	30
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	211
Clinical Trials:	171
Patent Applications:	4,151
Drug Prices:	Drug price information for NIACIN
Drug Sales Revenues:	Drug sales revenues for NIACIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NIACIN
DailyMed Link:	NIACIN at DailyMed

Drug patent expirations by year for NIACIN

Drug Prices for NIACIN

Recent Clinical Trials for NIACIN

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

Sponsor	Phase
Centre de recherche du Centre hospitalier universitaire de Sherbrooke	N/A
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval	N/A
Rhode Island Hospital	Early Phase 1

See all NIACIN clinical trials

Pharmacology for NIACIN

Drug Class	Nicotinic Acid

Medical Subject Heading (MeSH) Categories for NIACIN

Hypolipidemic Agents
Vasodilator Agents
Vitamin B Complex

US Patents and Regulatory Information for NIACIN

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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
Sandoz	NIACIN	niacin	TABLET;ORAL	083306-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Yichang Humanwell	NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	212017-001	Jun 10, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	NIACIN	niacin	TABLET;ORAL	085172-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	200484-002	Apr 23, 2014	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Yichang Humanwell	NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	212017-002	Jun 10, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	200484-001	Apr 23, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	203578-002	Jul 24, 2015	AB	RX	No	No	⤷ 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

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