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Last Updated: October 7, 2022

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, Jubilant Generics, Lannett Co Inc, Lupin Ltd, 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 twenty-nine 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 14th, 2005.

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Drug patent expirations by year for NIACIN
Drug Prices for NIACIN

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Drug Sales Revenue Trends for NIACIN

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Recent Clinical Trials for NIACIN

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SponsorPhase
National Institute on Drug Abuse (NIDA)Phase 2
University of Alabama at BirminghamPhase 2
New York UniversityPhase 2

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Pharmacology for NIACIN
Drug ClassNicotinic Acid
Medical Subject Heading (MeSH) Categories for NIACIN

US Patents and Regulatory Information for NIACIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs NIACIN niacin TABLET;ORAL 083305-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Halsey NIACIN niacin TABLET;ORAL 083453-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Yichang Humanwell NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 212017-003 Jun 10, 2019 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma NIACIN niacin TABLET;ORAL 083718-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Yichang Humanwell NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 212017-001 Jun 10, 2019 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal Pharms NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 203578-002 Jul 24, 2015 AB RX No No 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

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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.