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Last Updated: September 25, 2020

DrugPatentWatch Database Preview

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, Jubilant Generics, Lannett Co Inc, Lupin Ltd, Mylan, 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-two NDAs. Additional information is available in the individual branded drug profile pages.

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

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 University Medical CenterEarly Phase 1
Vanderbilt UniversityEarly 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 TITRATION STARTER PACK TABLET, EXTENDED RELEASE;ORAL niacin 020381
NIASPAN 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
Aurobindo Pharma Ltd NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 209236-001 Feb 1, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Tablicaps NIACIN niacin TABLET;ORAL 084237-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Wockhardt NIACIN niacin TABLET;ORAL 081134-001 Apr 28, 1992 AA RX No No   Start Trial   Start Trial   Start Trial
Intl Minerals TPN niacinamide; pyridoxine hydrochloride; tyrosine SUSPENSION;ORAL 008378-003 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Lupin Ltd NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 090860-001 Mar 20, 2014 AB RX 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

Expired US Patents for niacin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-003 Jul 28, 1997   Start Trial   Start Trial
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-002 Jul 28, 1997   Start Trial   Start Trial
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-001 Jul 28, 1997   Start Trial   Start Trial
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-004 Jul 28, 1997   Start Trial   Start Trial
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-003 Jul 28, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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