Data updated: Mar 10, 2026
NICORETTE (MINT)
NICOTINE POLACRILEX
Approved 1984-01-13
5
Indications
--
Phase 3 Trials
1
Priority Reviews
42
Years on Market
Details
- Status
- Over-the-counter
- First Approved
- 1984-01-13
- Routes
- BUCCAL
- Dosage Forms
- GUM, CHEWING
NICORETTE (MINT) Approval History
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What NICORETTE (MINT) Treats
5 FDA approvalsOriginally approved for its first indication in 1984 . Covers 5 distinct patient populations.
- Other (5)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NICORETTE (MINT) FDA Label Details
ProNICORETTE (MINT) Patents & Exclusivity
Latest Patent: Apr 2028
Patents (2 active)
US8323683
Expires Apr 30, 2028
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.