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Profile for Tradename: NIASPAN

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Niaspan is a drug marketed by Abbvie and is included in one NDA. It is available from nine suppliers. There are two patents protecting this drug.

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

The generic ingredient in NIASPAN is niacin. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the niacin profile page.

Summary for Tradename: NIASPAN

Suppliers / Packagers: see list38

Pharmacology for Tradename: NIASPAN

Ingredient-typeNicotinic Acids
Drug ClassNicotinic Acid

Clinical Trials for: NIASPAN

Assessment of Interaction Between Vytorin and Niaspan in Healthy Subjects (P04955AM2)
Status: Completed Condition: Hypercholesterolemia; Hyperlipidemia

Biosynthesis of PGD2 in Vivo
Status: Completed Condition: Healthy Volunteer

Niacin on Immune Activation : a Proof-of-concept Study
Status: Active, not recruiting Condition: HIV

Comparison of TRIA-662 500 mg and Niaspan 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions
Status: Completed Condition: Healthy

Randomized, Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery
Status: Completed Condition: Ischemic Stroke

Effect of Niacin on Transport of HDL and Relationship to Atherogenic Lipoproteins and Lipolysis
Status: Completed Condition: Healthy Volunteers

Study of the Effectiveness and Safety of Niaspan ® in the Treatment of Lipid Abnormalities in Latin America
Status: Completed Condition: Cardiovascular Diseases

Short-term Effect of Extended-release Niacin on Endothelial Function.
Status: Completed Condition: Hypoalphalipoproteinemia

Niacin, N-3 Fatty Acids and Insulin Resistance
Status: Completed Condition: Metabolic Syndrome; Hypertriglyceridemia

Effects of Niaspan™ on High-density Lipoprotein (HDL) in Healthy Male Subjects (0000-069)
Status: Completed Condition: Dyslipidemia

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
TABLET, EXTENDED RELEASE;ORAL020381-005Jul 28, 1997DISCNNo6,080,428<disabled> <disabled>
TABLET, EXTENDED RELEASE;ORAL020381-004Jul 28, 1997RXYes6,080,428<disabled> <disabled>
TABLET, EXTENDED RELEASE;ORAL020381-002Jul 28, 1997RXNo6,080,428<disabled> <disabled>
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Non-Orange Book Patents for Tradename: NIASPAN

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>
6,129,930 Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night<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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International Patent Family for Tradename: NIASPAN

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)9839002Sep 11, 1998
Canada2283322Sep 11, 1998
Brazil9815457Oct 16, 2001
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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