NDAINJECTIONINJECTABLE
Approved
May 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
ETOPOPHOS PRESERVATIVE FREE (etoposide phosphate) by Bristol Myers Squibb is 12. First approved in 1996.
Drug data last refreshed 39m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ETOPOPHOS PRESERVATIVE FREE is an intravenous chemotherapy agent containing etoposide phosphate, a prodrug that converts to the active topoisomerase II inhibitor etoposide. It induces DNA strand breaks leading to cell cycle arrest primarily at G2 phase and apoptosis in rapidly dividing cells. The preservative-free formulation addresses safety concerns in vulnerable patient populations requiring injectable cancer therapy.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); commercial team likely consolidating and focused on defending existing market share rather than expansion.
Mechanism of Action
12.1 Mechanism of Action Etoposide phosphate is a prodrug that is converted to its active moiety, etoposide, by dephosphorylation. Etoposide causes the induction of DNA strand breaks by an interaction with DNA-topoisomerase II or the formation of free radicals, leading to cell cycle arrest,…
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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.