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Last Updated: September 27, 2020

DrugPatentWatch Database Preview

NIACIN Drug 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, Jubilant Generics, Lannett Co Inc, Lupin Ltd, Mylan, 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-seven NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Niacin

A generic version of NIACIN was approved as niacin by WOCKHARDT on April 28th, 1992.

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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
University of MinnesotaPhase 1
Vanderbilt UniversityEarly Phase 1
Vanderbilt University Medical CenterEarly Phase 1

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Pharmacology for NIACIN
Drug ClassNicotinic Acid
Medical Subject Heading (MeSH) Categories for NIACIN
Paragraph IV (Patent) Challenges for NIACIN
Tradename Dosage Ingredient NDA Submissiondate
NIASPAN TABLET, EXTENDED RELEASE;ORAL niacin 020381
NIASPAN TITRATION STARTER PACK TABLET, EXTENDED RELEASE;ORAL niacin 020381

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
Mk Labs NIACIN niacin TABLET;ORAL 083525-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Halsey NIACIN niacin TABLET;ORAL 083453-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Purepac Pharm NIACIN niacin TABLET;ORAL 083271-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma NIACIN niacin TABLET;ORAL 083718-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Amneal Pharms NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 203578-002 Jul 24, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 203742-003 Feb 22, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Yichang Humanwell NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 212017-003 Jun 10, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
>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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