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.
| 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
|
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
Explore Our Curated Drug Screens
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 |
|---|---|---|---|---|
| ||||
| 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 |
| |
| Haleon Us Holdings |
|
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 |
