NDAINJECTIONINJECTABLE
Approved
Oct 1969
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
XYLOCAINE PRESERVATIVE FREE (lidocaine hydrochloride) by Fresenius Kabi is 12. Approved for pain. First approved in 1969.
Drug data last refreshed 1w ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XYLOCAINE PRESERVATIVE FREE is a lidocaine hydrochloride injectable local anesthetic that stabilizes neuronal membranes to inhibit ionic fluxes required for impulse initiation and conduction. It is indicated for pain management via injection across multiple routes and administration sites. The preservative-free formulation is critical for intrathecal and epidural use where preservative toxicity is a safety concern.
LOE Approaching
Product approaching loss of exclusivity with modest competitive pressure (30%); brand team likely focused on defending market share and managing generic transition rather than growth.
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.