NDAINJECTIONINJECTABLE
Approved
Aug 1976
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
DURANEST (epinephrine bitartrate; etidocaine hydrochloride) by AstraZeneca is 12. Approved for regional anesthesia, analgesia for surgery, dental and 4 more indications. First approved in 1976.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DURANEST is a combination injectable local anesthetic containing etidocaine hydrochloride and epinephrine bitartrate, approved in 1976 for regional anesthesia and pain management. It works by blocking nerve impulse generation and conduction, with epinephrine added as a vasoconstrictor to prolong duration of action. The drug is indicated for dental, oral surgery, obstetrical, and diagnostic/therapeutic procedures requiring local anesthesia.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand teams should anticipate transition planning and focus on defending market position against incoming generics.
Mechanism of Action
12.1 Mechanism of Action Bupivacaine blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, 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.