NDAORALTROCHE/LOZENGE
Approved
May 2009
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
9
Data completeness
4/8 — Partial
NICORETTE (nicotine polacrilex) by GSK. Approved for nicotine dependence, cigarette smoking behavior. First approved in 2009.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NICORETTE (nicotine polacrilex) is an oral lozenge formulation of nicotine, a cholinergic nicotinic agonist approved for nicotine dependence and smoking cessation. It delivers nicotine through the oral mucosa to reduce withdrawal symptoms and cravings in smokers attempting to quit. The drug binds to nicotinic receptors in the brain, providing both stimulant effects and reward reinforcement that help manage addiction.
Peak3.1 years to LOE
Product is in peak commercial phase with strong patent protection through 2029; brand teams should expect stable-to-declining headcount as LOE approaches in 3.2 years.
Mechanism of Action
Pharmacologic Class:
Cholinergic Nicotinic Agonist
Indications (2)
Clinical Trials (9)
To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product (Nicorette) in Healthy Smokers
Started Jun 2018
37 enrolled
Tobacco Use Disorder
Clinical Study to Assess Bioequivalence Between Nicorette Extra Mint Gum and Nicorette® Mint Gum in Healthy Smokers
Started Aug 2017
76 enrolled
Tobacco Dependence
"EASY EFFECTIVE SMOKELESS" With NICORETTE®
Started Apr 2011
184 enrolled
Stereotyped BehaviorTobacco Smoking Behavior
Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum
Started Dec 2009
76 enrolled
Tobacco Dependence
Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment
Started Feb 2009
300 enrolled
Tobacco Dependence
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.