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Niacin - Generic Drug Details

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Niacin is the generic ingredient in seven branded drugs marketed by Everylife, Watson Labs, Sandoz, Impax Labs, Hikma Pharms Llc, Sanofi Aventis Us, Mk Labs, Wockhardt, Tablicaps, Lupin Ltd, Barr, Halsey, Purepac Pharm, Medpointe Pharm Hlc, Sun Pharma Global, Amneal Pharms, Upsher Smith, Ivax Sub Teva Pharms, Abbvie, and Intl Minerals, and is included in twenty-seven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-nine patent family members in ten countries.

There are twelve drug master file entries for niacin. Nineteen suppliers are listed for this compound.

Summary for Generic Name: niacin

Tradenames:7
Patents:2
Applicants:20
NDAs:27
Drug Master File Entries: see list12
Suppliers / Packaging: see list19
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: niacin

Ingredient-typeNicotinic Acids
Drug ClassNicotinic Acid

Clinical Trials for: niacin

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upsher Smith
NIACOR
niacin
TABLET;ORAL040378-001May 3, 2000RXYes
Ivax Sub Teva Pharms
NIACIN
niacin
TABLET;ORAL083180-001Approved Prior to Jan 1, 1982DISCNNo
Abbvie
NIASPAN TITRATION STARTER PACK
niacin
TABLET, EXTENDED RELEASE;ORAL020381-005Jul 28, 1997DISCNNo6,080,428May 27, 2017
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Expired Orange Book Patents for Generic Ingredient: niacin

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-004Jul 28, 19976,406,715<disabled>
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-002Jul 28, 19977,011,848<disabled>
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-002Jul 28, 19976,406,715<disabled>
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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<disabled in preview>
6,676,967 Methods for reducing flushing in individuals being treated with nicotinic acid for hyperlipidemia<disabled in preview>
6,746,691 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics<disabled in preview>
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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
Finland991895<disabled in preview>
Finland991896<disabled in preview>
Australia6454598<disabled in preview>
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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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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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