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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Chubb
Fuji
Boehringer Ingelheim
Daiichi Sankyo
Moodys
Argus Health
Deloitte
Healthtrust
QuintilesIMS

Generated: November 19, 2017

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 Everylife, Watson Labs, Sandoz, Impax Labs, Hikma Pharms, Sanofi Aventis Us, Mk Labs, Wockhardt, Tablicaps, Lupin Ltd, Barr, Halsey, Purepac Pharm, Medpointe Pharm Hlc, Sun Pharma Global, Amneal Pharms, Upsher-smith Labs, Ivax Sub Teva Pharms, Abbvie, Lannett, 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

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;ORAL204178-001Dec 11, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-003Jul 28, 1997ABRXYesYes► Subscribe► Subscribe ► Subscribe
Barr
NIACIN
niacin
TABLET, EXTENDED RELEASE;ORAL076250-001Apr 14, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Impax Labs
NIACIN
niacin
TABLET;ORAL083115-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-002Jul 28, 1997ABRXYesNo► Subscribe► Subscribe ► Subscribe
Sun Pharma Global
NIACIN
niacin
TABLET, EXTENDED RELEASE;ORAL201273-001Apr 23, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Upsher-smith Labs
NIACOR
niacin
TABLET;ORAL040378-001May 3, 2000AARXNoYes► Subscribe► Subscribe► Subscribe
Intl Minerals
TPN
niacinamide; pyridoxine hydrochloride; tyrosine
SUSPENSION;ORAL008378-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms
NIACIN
niacin
TABLET, EXTENDED RELEASE;ORAL203578-002Jul 24, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
NIACIN
niacin
TABLET;ORAL085172-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: niacin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-004Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN TITRATION STARTER PACK
niacin
TABLET, EXTENDED RELEASE;ORAL020381-005Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-002Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-003Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-002Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-002Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-003Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-002Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN TITRATION STARTER PACK
niacin
TABLET, EXTENDED RELEASE;ORAL020381-005Jul 28, 1997► Subscribe► Subscribe
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-004Jul 28, 1997► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
7,998,506Nicotinic acid compositions for treating hyperlipidemia and related methods therefor► Subscribe
6,129,930 Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night► Subscribe
6,746,691 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics► Subscribe
7,011,848Hydrophobic component free sustained release nicotinic acid compositions for treating hyperlipidemia and related methods therefor► Subscribe
6,676,967 Methods for reducing flushing in individuals being treated with nicotinic acid for hyperlipidemia► Subscribe
6,406,715 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique urinary metabolite profiles► Subscribe
6,818,229 Intermediate release nicotinic acid compositions for treating hyperlipidemia► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: niacin

Country Document Number Estimated Expiration
European Patent Office2319513► Subscribe
Canada2574987► Subscribe
Australia6454598► Subscribe
European Patent Office0966284► Subscribe
Finland991895► Subscribe
European Patent Office0999844► Subscribe
European Patent Office0643965► Subscribe
Australia4751802► Subscribe
Brazil9815454► Subscribe
Canada2283322► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Cantor Fitzgerald
McKinsey
Dow
Novartis
Cipla
Covington
Julphar
Teva

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 verifification 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.

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