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Profile for Tradename: NICODERM CQ

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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-eight drug master file entries for this compound. Sixteen 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 list23

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, 19965,004,610<disabled>
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-006Aug 2, 19965,004,610<disabled>
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-004Aug 2, 19966,165,497<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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International Patent Family for Tradename: NICODERM CQ

Country Document Number Publication Date
Norway332084Jun 18, 2012
European Patent Office2158903Apr 14, 2010
Israel143778Apr 21, 2002
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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