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 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ETOPOPHOS PRESERVATIVE FREE is an injectable etoposide phosphate prodrug approved in 1996 for intravenous use in oncology. It is converted in plasma to etoposide, which induces DNA strand breaks via topoisomerase II inhibition, causing cell cycle arrest primarily at G2 phase and cell death. The preservative-free formulation addresses patient safety by eliminating potential irritants in injectable oncology regimens.
LOE Approaching
Product is approaching loss of exclusivity, signaling potential team consolidation or transition planning at Bristol Myers Squibb oncology division.
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.