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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. Eighteen 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 list18
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

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
Hikma Pharms Llc
NIACIN
niacin
TABLET;ORAL083718-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Mk Labs
NIACIN
niacin
TABLET;ORAL083525-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Watson Labs
NIACIN
niacin
TABLET;ORAL083305-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
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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;ORAL020381-002Jul 28, 19976,129,930<disabled>
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-003Jul 28, 19977,011,848<disabled>
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-003Jul 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
6,406,715 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique urinary metabolite profiles<disabled in preview>
7,998,506Nicotinic acid compositions for treating hyperlipidemia and related methods therefor<disabled in preview>
6,818,229 Intermediate release nicotinic acid compositions for treating hyperlipidemia<disabled in preview>
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International Patent Family for Ingredient: niacin

Country Document Number Estimated Expiration
Australia775967<disabled in preview>
Brazil9815457<disabled in preview>
Australia4751802<disabled in preview>
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