NDAINJECTIONINJECTABLE
Approved
Nov 1965
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
CITANEST FORTE DENTAL (epinephrine bitartrate; prilocaine hydrochloride) by AstraZeneca is mechanism of action prilocaine 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 1965.
Drug data last refreshed 1w ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CITANEST FORTE DENTAL is a combination local anesthetic injectable containing prilocaine hydrochloride and epinephrine bitartrate, approved for dental anesthesia in 1965. Prilocaine blocks neuronal sodium channels to inhibit impulse initiation and conduction, while epinephrine provides vasoconstriction to prolong anesthetic duration and reduce systemic absorption. The product is indicated for infiltration and nerve block anesthesia in dental procedures.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), indicating defensive positioning and potential team restructuring or consolidation efforts.
Mechanism of Action
Mechanism of Action Prilocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on CITANEST FORTE DENTAL offers limited growth opportunities given the approaching LOE and mature market position, making it most suitable for professionals seeking stability in a legacy product or interested in generic/OTC transition strategy. Career value lies in defensive commercial strategy, cost optimization, and maintaining market share rather than launching or expanding a growing franchise.
Product Manager
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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.