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NICODERM CQ Drug Profile

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Nicoderm Cq is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from five suppliers. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in twenty-three countries.

The generic ingredient in NICODERM CQ is nicotine. There are twenty-nine drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the nicotine profile page.

Summary for Tradename: NICODERM CQ

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list5

Clinical Trials for: NICODERM CQ

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-006Aug 2, 1996OTCYes8,999,379<disabled> <disabled>
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-005Aug 2, 1996OTCYes8,663,680<disabled>Y <disabled>
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-006Aug 2, 1996OTCYes8,663,680<disabled>Y <disabled>
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Expired Patents for Tradename: NICODERM CQ

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-004Aug 2, 19965,344,656<disabled>
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-006Aug 2, 19965,364,630<disabled>
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-004Aug 2, 19965,004,610<disabled>
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Paragraph IV activity for: NICODERM CQ

Drugname Dosage Strength RLD Submissiondate
nicotineTransdermal System7 mg/24 hrs, 14 mg/24 hrs, and 21 mg/24 hrsNicoderm CQ5/30/2014

Non-Orange Book Patents for Tradename: NICODERM CQ

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
7,622,136Transparent transdermal nicotine delivery devices<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: NICODERM CQ

Country Document Number Estimated Expiration
Czech Republic302035<disabled in preview>
Poland195871<disabled in preview>
Hungary0104728<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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