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NIASPAN Drug Profile

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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. Eighteen 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 list9

Pharmacology for Tradename: NIASPAN

Ingredient-typeNicotinic Acids
Drug ClassNicotinic Acid

Clinical Trials for: NIASPAN

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>
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Expired Patents for Tradename: NIASPAN

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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 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>
6,676,967 Methods for reducing flushing in individuals being treated with nicotinic acid for hyperlipidemia<disabled in preview>
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International Patent Family for Tradename: NIASPAN

Country Document Number Estimated Expiration
Canada2283322<disabled in preview>
Finland119910<disabled in preview>
Finland991895<disabled in preview>
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