NDAINJECTIONINJECTABLE
Approved
Mar 1975
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
LIDOPEN (lidocaine hydrochloride) by CooperSurgical is 12. First approved in 1975.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LIDOPEN (lidocaine hydrochloride) is a local anesthetic injectable that stabilizes neuronal membranes by inhibiting ionic flux, preventing initiation and conduction of nerve impulses. It is used for local and regional anesthesia across diverse surgical and procedural settings. The drug crosses blood-brain and placental barriers and is rapidly metabolized by the liver with an elimination half-life of 1.5–2 hours.
LOE Approaching
As a nearly 50-year-old generic with approaching loss of exclusivity, LIDOPEN operates in a mature, competitive market with minimal team expansion expected.
Mechanism of Action
12.1 Mechanism of Action Lidocaine hydrochloride stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses thereby effecting local anesthetic action. 12.2 Pharmacodynamics Excessive blood levels may cause changes in cardiac output, total…
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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.