Nicoderm Cq Patent Expiration

Nicoderm Cq is a drug owned by Chattem Inc Dba Sanofi Consumer Healthcare. It is protected by 5 US drug patents filed from 2013 to 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 22, 2021. Details of Nicoderm Cq's patents and their expiration are given in the table below.

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Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8075911 Transparent transdermal nicotine delivery devices
May, 2021

(5 years ago)

Expired
US8999379 Transparent transdermal nicotine delivery devices
Feb, 2020

(6 years ago)

Expired
US8663680 Transparent transdermal nicotine delivery devices
Feb, 2020

(6 years ago)

Expired
US9205059 Transparent transdermal nicotine delivery devices
Dec, 2019

(6 years ago)

Expired
US5508038 Polyisobutylene adhesives for transdermal devices
Apr, 2013

(13 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Nicoderm Cq's patents.

Given below is the list of recent legal activities going on the following patents of Nicoderm Cq.

Activity Date Patent Number
Patent litigations
Expire Patent 15 Jan, 2024 US8075911
Expire Patent 15 Jan, 2024 US9205059
Maintenance Fee Reminder Mailed 31 Jul, 2023 US8075911
Maintenance Fee Reminder Mailed 31 Jul, 2023 US9205059
Expire Patent 15 May, 2023 US8999379
Maintenance Fee Reminder Mailed 28 Nov, 2022 US8999379
Expire Patent 11 Apr, 2022 US8663680
Maintenance Fee Reminder Mailed 25 Oct, 2021 US8663680
Payment of Maintenance Fee, 8th Year, Large Entity 30 May, 2019 US8075911
Payment of Maintenance Fee, 4th Year, Large Entity 23 May, 2019 US9205059


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Nicoderm Cq and ongoing litigations to help you estimate the early arrival of Nicoderm Cq generic.

Nicoderm Cq's Litigations

Nicoderm Cq been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 28, 2010, against patent number US8075911. The petitioner , challenged the validity of this patent, with Robert M. Gale as the respondent. Click below to track the latest information on how companies are challenging Nicoderm Cq's patents.

Last updated on October 6, 2026
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8075911 June, 2010 Decision
(25 May, 2011)
Robert M. Gale

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US patents provide insights into the exclusivity only within the United States, but Nicoderm Cq is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Nicoderm Cq's family patents as well as insights into ongoing legal events on those patents.

Nicoderm Cq's Family Patents


Family Patents

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Clinical Trials

Recent Clinical Trials on Nicoderm Cq:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Memory Improvement Through Nicotine Dosing (MIND) Study University of Southern California NA COMPLETED
(Sep 1, 2026)
PHASE2
Imaging Sex Differences in Smoking-Induced Pulmonary Inflammation University of Pennsylvania NA RECRUITING
(Sep 1, 2026)
PHASE1
Targeting Orexin to Treat Nicotine Dependence Mclean Hospital NA COMPLETED
(Sep 1, 2026)
PHASE1
Optimizing Tobacco Use Treatment for PLWHA Abramson Cancer Center at Penn Medicine NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
Overcoming Nicotine Dependence to Enable Quitting Rush University Medical Center NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Smoking (Trial 1) State University of New York at Buffalo NA COMPLETED
(Sep 1, 2026)
PHASE2, PHASE3
Acute Nicotine Gum and Tinnitus Loudness in Non-Smoking Adults San Diego State University NA COMPLETED
(Sep 1, 2026)
PHASE1, PHASE2
Understanding Oral Nicotine Pouch Use in Healthy Volunteers University of California, San Francisco NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1
Depressed Mood Improvement Through Nicotine Dosing 3 Vanderbilt University Medical Center NA COMPLETED
(Aug 1, 2026)
PHASE2
Depressed Mood Improvement Through Nicotine Dosing-3 (Depressed MIND3) Extension Vanderbilt University Medical Center NA COMPLETED
(Aug 1, 2026)
PHASE2
Informing Oral Nicotine Pouch Regulations to Promote Public Health Ohio State University Comprehensive Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE2
Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention for Smoking Cessation University of Oklahoma NA RECRUITING
(Aug 1, 2026)
PHASE2
Nicotine Pouch Pharmacokinetics Abuse Liability JT International SA NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder University of Illinois at Chicago NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
THCV Treatment for Smokers University of California, Los Angeles NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
DOSE-UP: Dose Optimization for Smoking and E-Cigarette Use Pharmacotherapy Medical University of South Carolina NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Evaluation of PAN-90806 Eye Drops in Healthy Subjects Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Impact of Sweeteners on the Addictive Threshold of Nicotine Yale University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement Rutgers, The State University of New Jersey NA RECRUITING
(Jul 1, 2026)
PHASE3
Exploration of Synaptotrophic Effects of Psilocybin in Opioid Use Disorder (OUD) Yale University NA RECRUITING
(Jul 1, 2026)
PHASE1
Kick-Nic! Youth Quit Vaping App Yale University NA RECRUITING
(Jul 1, 2026)
PHASE2
Enhancing Smoking Cessation for African American People Everywhere University of Houston NA RECRUITING
(Jul 1, 2026)
PHASE2
Multi-Site Trial of Tirzepatide for Smoking Cessation University of Southern California NA RECRUITING
(Jul 1, 2026)
PHASE2
Nicotinic Receptor Genetic Variation and Alcohol Reward National Institute on Alcohol Abuse and Alcoholism (NIAAA) NA RECRUITING
(Jun 25, 2026)
PHASE1
Smoking Cessation for Depressed Smokers M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Omega-3 Fatty Acids for Smoking Cessation in Pregnancy Vanderbilt University Medical Center NA COMPLETED
(Jun 1, 2026)
PHASE2
Effects of Menthol in E-cigarettes on Smoking Behaviors Yale University NA COMPLETED
(Jun 1, 2026)
PHASE1
Acute Pharmacokinetic and Pharmacodynamic Effects of "Tobacco-Free" Oral Nicotine Pouches in Smokers Johns Hopkins University NA COMPLETED
(Jun 1, 2026)
PHASE1
Evaluating Smoking Cessation Interventions for PWH in South Africa Johns Hopkins University NA RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
Free Samples for Health Sandra Japuntich NA COMPLETED
(Jun 1, 2026)
PHASE2
E-cigarette Harm Reduction Among PLWHA in South Africa NYU Langone Health NA COMPLETED
(Jun 1, 2026)
PHASE1
Effects of Ketones on Brain Energetics and Alcohol Consumption in Alcohol Use Disorder University of Pennsylvania NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
iCanQuit Smoking Cessation Among Hispanic Adults Fred Hutchinson Cancer Center NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE3
A Study Of Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation Mayo Clinic NA RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
Comparative Evaluation of Nicotine Analogs Ohio State University Comprehensive Cancer Center NA RECRUITING
(Jun 1, 2026)
PHASE1
Biomarkers of Exposure and Effect in Standardized Research E-cigarette (SREC) Users Masonic Cancer Center, University of Minnesota NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1
Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women University of Vermont NA COMPLETED
(May 1, 2026)
PHASE1, PHASE2
Community-based Smoking Cessation Treatment for Adults With High Stress Sensitivity. Jasper A. Smits NA RECRUITING
(May 1, 2026)
PHASE3
Empowering Cessation ACS South Region University of Oklahoma NA RECRUITING
(May 1, 2026)
PHASE2, PHASE3
Acute Effects of Cannabis on Cognition and Affect Washington State University NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Ketamine Alcohol (in Treatment-Resistant Depression) Mark Niciu NA RECRUITING
(Apr 1, 2026)
PHASE2
Mobile App for Smoking Cessation and Mental Health University of Oklahoma NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Integrating Financial Coaching and Smoking Cessation Coaching NYU Langone Health NA RECRUITING
(Apr 1, 2026)
PHASE3
Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors Washington University School of Medicine NA RECRUITING
(Apr 1, 2026)
PHASE1
Dyadic Financial Incentive Treatments for Dual Smoker Couples University of Oklahoma NA RECRUITING
(Apr 1, 2026)
PHASE2
Effect of Cannabis on E-Cigarette Use Behavior Johns Hopkins University NA RECRUITING
(Apr 1, 2026)
PHASE1
COMP-4 Supplementation and Brachial Artery FMD University of California, Los Angeles NA COMPLETED
(Mar 1, 2026)
PHASE1, PHASE2
Exenatide for Smoking Cessation and Prevention of Weight Gain The University of Texas Health Science Center, Houston NA COMPLETED
(Mar 1, 2026)
PHASE2
Mindfulness-Based Ecological Momentary Intervention For Smoking Cessation Among Cancer Survivors H. Lee Moffitt Cancer Center and Research Institute NA COMPLETED
(Mar 1, 2026)
PHASE1




Generic Launch

Generic Release Date:

Nicoderm Cq's generic launch date based on the expiry of its last outstanding patent is estimated to be May 22, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Nicoderm Cq Generic API suppliers:

Nicotine is the generic name for the brand Nicoderm Cq. 1 company has already filed for the generic of Nicoderm Cq. Check out the entire list of companies who have already received approval for Nicoderm Cq's generic

How can I launch a generic of Nicoderm Cq before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Nicoderm Cq's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nicoderm Cq's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Nicoderm Cq -

Strength Submission Date Expiration Date of Last Qualifying Patent 180-Day Status First Applicant Approval Generic Competition Status
25 mg / 5 mL
🔒 Unlock
30 May, 2014 22 May, 2021 Extinguished Less


Alternative Brands for Nicoderm Cq

Nicoderm Cq which is used for reducing withdrawal symptoms and nicotine cravings during smoking cessation., has several other brand drugs using the same active ingredient (Nicotine). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name
Haleon Us Holdings
Nicorette
Pfizer Inc
Nicotrol


Apart from brand drugs containing the same ingredient, some generics have also been filed for Nicotine, Nicoderm Cq's active ingredient. Check the complete list of approved generic manufacturers for Nicoderm Cq





About Nicoderm Cq

Nicoderm Cq is a drug owned by Chattem Inc Dba Sanofi Consumer Healthcare. It is used for reducing withdrawal symptoms and nicotine cravings during smoking cessation. Nicoderm Cq uses Nicotine as an active ingredient. Nicoderm Cq was launched by Chattem Sanofi in 1996.

Approval Date:

Nicoderm Cq was approved by FDA for market use on 02 August, 1996.

Active Ingredient:

Nicoderm Cq uses Nicotine as the active ingredient. Check out other Drugs and Companies using Nicotine ingredient

Treatment:

Nicoderm Cq is used for reducing withdrawal symptoms and nicotine cravings during smoking cessation.

Dosage:

Nicoderm Cq is available in film, extended release form for transdermal use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
14MG/24HR FILM, EXTENDED RELEASE Over the counter TRANSDERMAL
7MG/24HR FILM, EXTENDED RELEASE Over the counter TRANSDERMAL
21MG/24HR FILM, EXTENDED RELEASE Over the counter TRANSDERMAL