Relieves nicotine withdrawal symptoms. Sold as Prostep, Habitrol, Nicoderm Cq, Nicotrol. Every FDA application for this active ingredient: 6 branded and 1 generic.
As of Nov 13, 2026, FDA lists 7 applications for Nicotine (sold as Prostep, Habitrol, Nicoderm Cq and others), first approved Nov 7, 1991, with 4 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Nicotrol Ns | Part D | $8.4M | +10% | 4,557 |
| Nicotrol | Part D | $79K | -89% | 96 |
| Study | Phase | Status | Posted |
|---|---|---|---|
| Digital ACT Psychological Support for Primary Caregivers of Older Adults With Severe Mental IllnessSevere Mental Disorders, Caregiver · Harbin Medical University | Not applicable | Not yet recruiting | Nov 12, 2026 |
| Alberta Cancer Exercise Dose in Colorectal CancerCancer, Colorectal Cancer · University of Calgary | Phase 2 | Not yet recruiting | Nov 3, 2026 |
| Examining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among AdolescentsSelf Injurious Behavior, Self Injurious Behavior Without Suicidal Intent · University of Haifa | Not applicable | Not yet recruiting | Nov 3, 2026 |
| §SMOKE Nicotine and Tobacco Youth CohortTobacco Use Behavior, Nicotine Dependence Tobacco Product · University of Southern Denmark | — | Recruiting | Nov 2, 2026 |
| Neurostructural and Biochemical Signatures of Tobacco Smoking in Mood DisordersMajor Depressive Disorder, Bipolar Disorder · Assiut University | — | Not yet recruiting | Nov 2, 2026 |
| Studying Different Ways of Using Oral Nicotine Pouches to Understand the Effect on Nicotine Delivery, Appeal, and Side Effects Among Adult Cigarette SmokersCigarette Smoking-Related Carcinoma · Ohio State University Comprehensive Cancer Center | Not applicable | Not yet recruiting | Oct 28, 2026 |
| Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT TrialTobacco Cessation, Electronic Nicotine Delivery Systems · Roswell Park Cancer Institute | Not applicable | Not yet recruiting | Oct 27, 2026 |
| Phase 1: Thrive TogetherAttention-Deficit/Hyperactivity Disorder (ADHD) · Boston Children's Hospital | — | Not yet recruiting | Oct 26, 2026 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Nov 7, 1991 | Nicoderm CqNDA 20165 · New dosage form | Chattem Sanofi | 29 | Marketed |
| Nov 27, 1991 | HabitrolNDA 20076 · New dosage form | Dr Reddys Labs SA | 32 | Marketed |
| Jan 28, 1992 | ProstepNDA 19983 · New dosage form | Aveva | 11 | Discontinued |
| Mar 22, 1996 | NicotrolNDA 20385 · New dosage form | Pfizer Inc | 8 | Marketed |
| Jul 3, 1996 | NicotrolNDA 20536 · TYPE 8 | Mcneil Cons | 7 | Discontinued |
| May 2, 1997 | NicotrolNDA 20714 · New dosage form | Pfizer | 14 | Discontinued |
| Oct 20, 1997 | NicotineANDA 74612 | Difgen Pharms | 10 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Pfizer