Nicotrol Patent Expiration

Nicotrol is a drug owned by Pfizer Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 12, 2014. Details of Nicotrol'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).
US5656255 Composition to help stop smoking
Aug, 2014

(12 years ago)

Expired

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US patents provide insights into the exclusivity only within the United States, but Nicotrol 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 Nicotrol's family patents as well as insights into ongoing legal events on those patents.

Nicotrol's Family Patents


Family Patents

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Clinical Trials

Recent Clinical Trials on Nicotrol:

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:

Nicotrol's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 12, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Nicotrol Generic API suppliers:

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

Alternative Brands for Nicotrol

There are several other brand drugs using the same active ingredient (Nicotine) as Nicotrol. 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
Chattem Sanofi
Nicoderm Cq
Haleon Us Holdings
Nicorette


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





About Nicotrol

Nicotrol is a drug owned by Pfizer Inc. Nicotrol uses Nicotine as an active ingredient. Nicotrol was launched by Pfizer in 1996.

Approval Date:

Nicotrol was approved by FDA for market use on 22 March, 1996.

Active Ingredient:

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

Dosage:

Nicotrol is available in spray, metered form for nasal use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.5MG/SPRAY SPRAY, METERED Prescription NASAL