NDABUCCALFILM, EXTENDED RELEASE
Approved
May 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
DENTIPATCH (lidocaine) by Noven Pharmaceuticals is clinical pharmacology mechanism of action: lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. First approved in 1996.
Drug data last refreshed 32m ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DENTIPATCH is a buccal film formulation of lidocaine 5% approved in 1996 for topical anesthesia of oral mucous membranes. It works by stabilizing neuronal membranes to inhibit ionic fluxes required for impulse initiation and conduction, producing local anesthetic effects with onset in 3–5 minutes. The extended-release film delivery system enables sustained anesthesia at the site of application.
LOE Approaching
As a legacy topical anesthetic approaching loss of exclusivity with moderate competitive pressure (30), brand teams face declining revenues and rightsizing, limiting growth opportunities.
Mechanism of Action
CLINICAL PHARMACOLOGY Mechanism of action: Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Onset of anesthesia: Lidocaine Ointment 5% effects local, topical anesthesia. The…
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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.