NDATRANSDERMALFILM, EXTENDED RELEASE
Approved
Nov 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
HABITROL (nicotine) by Dr. Reddy's Laboratories is pharmacologic action nicotine, the chief alkaloid in tobacco products, binds stereo-selectively to nicotinic-cholinergic receptors at the autonomic ganglia, in the adrenal medulla, at neuromuscular junctions, and in the brain. First approved in 1991.
Drug data last refreshed 19h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HABITROL is a transdermal nicotine patch (extended-release film) approved in 1991 for smoking cessation and tobacco use disorder. It works by binding stereo-selectively to nicotinic-cholinergic receptors in the brain, autonomic ganglia, and adrenal medulla, producing stimulant effects at low doses and reward effects at high doses to reduce nicotine craving and withdrawal. The product is a first-line nicotine replacement therapy widely used as an adjunct to behavioral interventions.
LOE Approaching
Approaching loss of exclusivity with moderate competitive pressure (30), indicating a contracting brand team and focus on cost management rather than growth initiatives.
Mechanism of Action
Pharmacologic Action Nicotine, the chief alkaloid in tobacco products, binds stereo-selectively to nicotinic-cholinergic receptors at the autonomic ganglia, in the adrenal medulla, at neuromuscular junctions, and in the brain. Two types of central nervous system effects are believed to be the basis…
Pharmacologic Class:
Cholinergic Nicotinic Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes
Started May 2026
800 enrolled
Vaping Cessation
Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation
Started Apr 2025
150 enrolled
Tobacco
Pilot Study of the YES-CAN! Program to Prevent Youth Nicotine Vaping
Started Aug 2024
1,166 enrolled
Nicotine Vaping
Nicotine Influence on the Retina Following the Use of Electronic Cigarette
Started Aug 2022
44 enrolled
Electronic Cigarette UseRetina; Change
Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy
Started Jan 2022
1,307 enrolled
Nicotine Addiction
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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.