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Last Updated: April 17, 2024

Niacin - Generic Drug Details

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What are the generic sources for niacin and what is the scope of patent protection?

Niacin is the generic ingredient in seven branded drugs marketed by Medpointe Pharm Hlc, Amneal Pharms, Aurobindo Pharma Ltd, Barr, Beijing, Chartwell Rx, Eywa, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Rising, Sun Pharm, Yichang Humanwell, Abbvie, Everylife, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mk Labs, Purepac Pharm, Sandoz, Tablicaps, Watson Labs, Wockhardt, Avondale Pharms, Sanofi Aventis Us, and Intl Minerals, and is included in thirty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for niacin. Eleven suppliers are listed for this compound.

Summary for niacin

US Patents:	0
Tradenames:	7
Applicants:	28
NDAs:	35
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	211
Clinical Trials:	169
Patent Applications:	3,500
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for niacin
Drug Sales Revenues:	Drug sales revenues for niacin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for niacin
What excipients (inactive ingredients) are in niacin?	niacin excipients list
DailyMed Link:	niacin at DailyMed

See drug prices for niacin

See drug sales revenues for niacin

Recent Clinical Trials for niacin

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

Sponsor	Phase
Rhode Island Hospital	Early Phase 1
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Phase 2
University of Alabama at Birmingham	Phase 2

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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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
Rising	NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	203742-002	Feb 22, 2019		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm	NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	200484-001	Apr 23, 2014	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amneal Pharms	NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	204178-001	Dec 11, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Barr	NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	076378-001	Apr 26, 2005	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Avondale Pharms	NIACOR	niacin	TABLET;ORAL	040378-001	May 3, 2000		RX	No	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

Expired US Patents for niacin

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-004	Jul 28, 1997	⤷ Try a Trial	⤷ Try a Trial
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-004	Jul 28, 1997	⤷ Try a Trial	⤷ Try a Trial
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-002	Jul 28, 1997	⤷ Try a Trial	⤷ Try a Trial
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-004	Jul 28, 1997	⤷ Try a Trial	⤷ Try a Trial
Abbvie	NIASPAN	niacin	TABLET, EXTENDED RELEASE;ORAL	020381-002	Jul 28, 1997	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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