NDABUCCALGUM, CHEWINGPriority Review
Approved
Jan 1984
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
9
Data completeness
4/8 — Partial
Priority Review
NICORETTE (nicotine polacrilex) by GSK. Approved for nicotine dependence, cigarette smoking cessation. First approved in 1984.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NICORETTE (nicotine polacrilex) is a buccal chewing gum formulation that delivers nicotine to treat nicotine dependence and support cigarette smoking cessation. The drug works as a cholinergic nicotinic agonist, binding to nicotinic receptors in the brain to reduce cravings and withdrawal symptoms. It is an OTC product approved in 1984 and remains a cornerstone of nicotine replacement therapy.
LOE Approaching2.0 years to LOE
NICORETTE faces accelerating generic competition and patent expiry in 2028; brand team focus is expected to shift toward line extensions, OTC category defense, and cost management.
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.