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Last Updated: October 7, 2022

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, 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-four 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
New York UniversityPhase 2
Johns Hopkins UniversityPhase 2
National Institute on Drug Abuse (NIDA)Phase 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
Amneal Pharms NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 203578-001 Jul 24, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-004 Jul 28, 1997 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 209236-002 Feb 1, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 201273-001 Apr 23, 2014 AB RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Barr NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 076378-002 Apr 26, 2005 AB RX 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
>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 020381-004 Jul 28, 1997 See Plans and Pricing See Plans and Pricing
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-003 Jul 28, 1997 See Plans and Pricing See Plans and Pricing
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-003 Jul 28, 1997 See Plans and Pricing See Plans and Pricing
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-002 Jul 28, 1997 See Plans and Pricing See Plans and Pricing
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-004 Jul 28, 1997 See Plans and Pricing See Plans and Pricing
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-002 Jul 28, 1997 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.