NDAINJECTIONINJECTABLE
Approved
Jun 1980
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
DEPO-TESTADIOL (estradiol cypionate; testosterone cypionate) by Pfizer is clinical pharmacology endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Approved for the treatment of: 1. First approved in 1980.
Drug data last refreshed 22h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DEPO-TESTADIOL is a fixed-dose combination injectable containing estradiol cypionate and testosterone cypionate, designed for hormone replacement or hormonal management. The estradiol component acts through nuclear receptor binding to modulate reproductive function and secondary sexual characteristics, while the testosterone provides androgenic effects. This parenteral formulation uses cypionate esters to achieve prolonged absorption over several weeks from a single intramuscular injection.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand team focus likely shifting toward generic transition planning and niche positioning.
Mechanism of Action
CLINICAL PHARMACOLOGY Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal…
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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.