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Last Updated: March 3, 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, Eywa, Jubilant Generics, Lannett Co Inc, Lupin Ltd, 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.

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
Rhode Island HospitalEarly Phase 1
Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshPhase 2
New York UniversityPhase 2

See all niacin clinical trials

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
Aurobindo Pharma Ltd NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 209236-001 Feb 1, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us NICOLAR niacin TABLET;ORAL 083823-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-002 Jul 28, 1997 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 090892-001 Mar 20, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Beijing NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 214428-001 Nov 22, 2021 DISCN No No ⤷  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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-002 Jul 28, 1997 ⤷  Try a Trial ⤷  Try a Trial
Abbvie NIASPAN TITRATION STARTER PACK niacin TABLET, EXTENDED RELEASE;ORAL 020381-005 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 020381-001 Jul 28, 1997 ⤷  Try a Trial ⤷  Try a Trial
Abbvie NIASPAN TITRATION STARTER PACK niacin TABLET, EXTENDED RELEASE;ORAL 020381-005 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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