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Serving leading biopharmaceutical companies globally:

Cerilliant
US Army
Queensland Health
McKesson
Novartis
Boehringer Ingelheim
Chubb
Daiichi Sankyo
US Department of Justice
Baxter

Generated: January 20, 2018

DrugPatentWatch Database Preview

Niacin - Generic Drug Details

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What are the generic drug sources for niacin and what is the scope of niacin freedom to operate?

Niacin
is the generic ingredient in seven branded drugs marketed by Medpointe Pharm Hlc, Amneal Pharms, Barr, Lannett, Lupin Ltd, Sun Pharma Global, Abbvie, Everylife, Halsey, Hikma Pharms, 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 twenty-eight NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Niacin has twenty-nine patent family members in ten countries.

There are fourteen drug master file entries for niacin. Twenty-two suppliers are listed for this compound.
Pharmacology for niacin
Ingredient-typeNicotinic Acids
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
Halsey NIACIN niacin TABLET;ORAL 083453-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Lupin Ltd NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 090446-001 Mar 20, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us NICOLAR niacin TABLET;ORAL 083823-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-004 Jul 28, 1997 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Everylife NIACIN niacin TABLET;ORAL 083203-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Lannett NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 203899-002 Jun 16, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Purepac Pharm NIACIN niacin TABLET;ORAL 083271-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Amneal Pharms NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 203578-001 Jul 24, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Avondale Pharms NIACOR niacin TABLET;ORAL 040378-001 May 3, 2000 AA RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Lupin Ltd NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 090892-001 Mar 20, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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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Expired US Patents for niacin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-001 Jul 28, 1997 ➤ Subscribe ➤ Subscribe
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-003 Jul 28, 1997 ➤ Subscribe ➤ Subscribe
Abbvie NIASPAN TITRATION STARTER PACK niacin TABLET, EXTENDED RELEASE;ORAL 020381-005 Jul 28, 1997 ➤ Subscribe ➤ Subscribe
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-003 Jul 28, 1997 ➤ Subscribe ➤ Subscribe
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-004 Jul 28, 1997 ➤ Subscribe ➤ Subscribe
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-004 Jul 28, 1997 ➤ Subscribe ➤ Subscribe
Abbvie NIASPAN TITRATION STARTER PACK niacin TABLET, EXTENDED RELEASE;ORAL 020381-005 Jul 28, 1997 ➤ Subscribe ➤ Subscribe
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-003 Jul 28, 1997 ➤ Subscribe ➤ Subscribe
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-001 Jul 28, 1997 ➤ Subscribe ➤ Subscribe
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-001 Jul 28, 1997 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for niacin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,818,229 Intermediate release nicotinic acid compositions for treating hyperlipidemia ➤ Subscribe
6,129,930 Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night ➤ Subscribe
6,406,715 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique urinary metabolite profiles ➤ Subscribe
7,011,848 Hydrophobic component free sustained release nicotinic acid compositions for treating hyperlipidemia and related methods therefor ➤ Subscribe
6,746,691 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics ➤ Subscribe
6,676,967 Methods for reducing flushing in individuals being treated with nicotinic acid for hyperlipidemia ➤ Subscribe
7,998,506 Nicotinic acid compositions for treating hyperlipidemia and related methods therefor ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for niacin

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
US Army
Fuji
McKesson
QuintilesIMS
Covington
Farmers Insurance
Julphar

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