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NIASPAN TITRATION STARTER PACK Drug Profile

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Niaspan Titration Starter Pack is a drug marketed by Abbvie and is included in one NDA. It is available from nine suppliers. There is one patent protecting this drug.

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

The generic ingredient in NIASPAN TITRATION STARTER PACK 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 TITRATION STARTER PACK

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list9

Pharmacology for Tradename: NIASPAN TITRATION STARTER PACK

Ingredient-typeNicotinic Acids
Drug ClassNicotinic Acid

Clinical Trials for: NIASPAN TITRATION STARTER PACK

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>
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Expired Patents for Tradename: NIASPAN TITRATION STARTER PACK

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
NIASPAN TITRATION STARTER PACK
niacin
TABLET, EXTENDED RELEASE;ORAL020381-005Jul 28, 19977,011,848<disabled>
Abbvie
NIASPAN TITRATION STARTER PACK
niacin
TABLET, EXTENDED RELEASE;ORAL020381-005Jul 28, 19976,129,930<disabled>
Abbvie
NIASPAN TITRATION STARTER PACK
niacin
TABLET, EXTENDED RELEASE;ORAL020381-005Jul 28, 19976,746,691<disabled>
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Non-Orange Book Patents for Tradename: NIASPAN TITRATION STARTER PACK

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
6,746,691 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics<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>
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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 Tradename: NIASPAN TITRATION STARTER PACK

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