NDAINTRAMUSCULARFOR SUSPENSION
Approved
Aug 2018
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
9
Data completeness
5/8 — Partial
LEUPROLIDE ACETATE FOR DEPOT SUSPENSION (leuprolide acetate) by Gen Pharmaceuticals is acetate, a gnrh agonist, acts as an inhibitor of gonadotropin secretion. Approved for prostate cancer, central precocious puberty, endometriosis. First approved in 2018.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Leuprolide acetate is a GnRH agonist administered as an intramuscular depot suspension that suppresses gonadotropin secretion and steroid hormone production. It is indicated for prostate cancer, endometriosis, central precocious puberty, infertility, and off-label use in breast cancer, lymphoma, PCOS, and menopause management. The drug works through initial stimulation followed by sustained suppression of ovarian and testicular function, leading to atrophy of reproductive organs and inhibition of hormone-dependent tumor growth.
Peak
Product is at peak commercial maturity with moderate competitive pressure (30/100); team focus is on market maintenance and indication expansion rather than primary growth.
Mechanism of Action
acetate, a GnRH agonist, acts as an inhibitor of gonadotropin secretion. Animal studies indicate that following an initial stimulation, continuous administration of leuprolide acetate results in suppression of ovarian and testicular steroidogenesis. This effect was reversible upon discontinuation…
Indications (3)
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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.