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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

Patents:2
Applicants:1
NDAs:1
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

Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients
Status: Recruiting Condition: Chronic Renal Failure; Hemodialysis

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

Courtesy of ClinicalTrials.org
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
Abbvie
NIASPAN TITRATION STARTER PACK
niacin
TABLET, EXTENDED RELEASE;ORAL020381-005Jul 28, 1997DISCNNo6,080,428<disabled><disabled>
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-004Jul 28, 1997RXYes6,080,428<disabled><disabled>
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-002Jul 28, 1997RXNo6,080,428<disabled><disabled>
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-003Jul 28, 1997RXYes6,469,035<disabled><disabled>
Abbvie
NIASPAN
niacin
TABLET, EXTENDED RELEASE;ORAL020381-004Jul 28, 1997RXYes6,469,035<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
7,011,848Hydrophobic component free sustained release nicotinic 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>
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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International Patent Family for Tradename: NIASPAN

Country Document Number Publication Date
European Patent Office0966284Dec 29, 1999
Brazil9815454Oct 23, 2001
World Intellectual Property Organization (WIPO)9906052Feb 11, 1999
Finland991895Sep 22, 1999
Norway994275Sep 02, 1999
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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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