HYDROXYPROGESTERONE CAPROATE
LOE ApproachingNDAINJECTIONINJECTABLE
Approved
Dec 1974
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
HYDROXYPROGESTERONE CAPROATE by AbbVie is clinical pharmacology hydroxyprogesterone is a potent, long-acting, progestational steroid ester which transforms proliferative endothelium into secretory endothelium, induces mammary gland duct development, and inhibits the production and/or release of gonadotropic hormone; it also shows slight estrogenic, androgenic, or corticoid effects as well, but should not be relied upon for these effects. Approved for non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (stage iii. First approved in 1974.
Drug data last refreshed 1h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Hydroxyprogesterone caproate is a long-acting progestational steroid ester administered by intramuscular injection. It is indicated for treatment of advanced adenocarcinoma of the uterine corpus (Stage III) in non-pregnant women, where it induces regressive changes in tumor tissue. The drug works by transforming proliferative endometrium into secretory endometrium and inhibiting gonadotropic hormone production.
LOE Approaching
This legacy product is approaching loss of exclusivity with minimal competitive pressure (30%), signaling a small, focused brand team managing wind-down activities.
Mechanism of Action
CLINICAL PHARMACOLOGY Hydroxyprogesterone is a potent, long-acting, progestational steroid ester which transforms proliferative endothelium into secretory endothelium, induces mammary gland duct development, and inhibits the production and/or release of gonadotropic hormone; it also shows slight…
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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.