Nicotine Patent Expiration
Nicotine was first introduced by Pfizer Inc
Nicotine Patents
Given below is the list of patents protecting Nicotine, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Nicoderm Cq | US8075911 | Transparent transdermal nicotine delivery devices |
May 22, 2021
(Expired) | Chattem Sanofi |
| Nicoderm Cq | US8663680 | Transparent transdermal nicotine delivery devices |
Feb 13, 2020
(Expired) | Chattem Sanofi |
| Nicoderm Cq | US8999379 | Transparent transdermal nicotine delivery devices |
Feb 13, 2020
(Expired) | Chattem Sanofi |
| Nicoderm Cq | US9205059 | Transparent transdermal nicotine delivery devices |
Dec 15, 2019
(Expired) | Chattem Sanofi |
| Nicotrol | US5656255 | Composition to help stop smoking |
Aug 12, 2014
(Expired) | Pfizer Inc |
| Nicoderm Cq | US5508038 | Polyisobutylene adhesives for transdermal devices |
Apr 16, 2013
(Expired) | Chattem Sanofi |
Nicotine's Family Patents
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Clinical Trials
Recent Clinical Trials on Nicotine:
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 |