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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 three patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-seven patent family members in twenty-two countries.

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

Summary for Tradename: NICODERM CQ

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list23

Clinical Trials for: NICODERM CQ

Neural Mechanisms Underlying Nicotine and Alcohol Combinations
Status: Active, not recruiting Condition: Focus: Effects of Nicotine and Alcohol on Brain Circuits

Transdermal Patch CVD 1000: The Effect of Heat on Nicotine Release From Nicotine Patches in Adult Smokers
Status: Active, not recruiting Condition: Smoking

Pilot Pharmacokinetic Study of Investigational Sublingual Nicotine Tablet Versus COMMIT Nicotine Lozenge
Status: Completed Condition: Nicotine Pharmacokinetic Study

Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes
Status: Completed Condition: Nicotine Dependence

Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product
Status: Completed Condition: Tobacco Dependence

Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations
Status: Completed Condition: Smoking Cessation

Nicotine Vaccination and Nicotinic Receptor Occupancy
Status: Completed Condition: Nicotine Dependence

Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.
Status: Completed Condition: Tobacco Dependence

Pharmacogenetics of Nicotine Addiction Treatment
Status: Active, not recruiting Condition: Nicotine Addiction

Electronic Nicotine Delivery Systems as a Smoking Cessation Treatment
Status: Not yet recruiting Condition: Nicotine Dependence

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
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;TRANSDERMAL020165-004Aug 2, 1996OTCYes8,999,379<disabled><disabled>
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-005Aug 2, 1996OTCYes8,999,379<disabled><disabled>
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-004Aug 2, 1996OTCYes8,075,911<disabled>Y<disabled>
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-006Aug 2, 1996OTCYes8,075,911<disabled>Y<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
World Intellectual Property Organization (WIPO)0037058Jun 29, 2000
European Patent Office1140039Oct 10, 2001
Brazil9916214Sep 11, 2001
Denmark1140039Mar 22, 2010
Austria447398Nov 15, 2009
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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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