NDAINTRAMUSCULARFOR SUSPENSION
Approved
Aug 2018
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
9
Data completeness
4/8 — Partial
LEUPROLIDE ACETATE FOR DEPOT SUSPENSION (leuprolide acetate) by Gen Pharmaceuticals is acetate, a gnrh agonist, acts as an inhibitor of gonadotropin secretion. First approved in 2018.
Drug data last refreshed 17h ago · AI intelligence enriched 1w 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 reduces ovarian and testicular steroidogenesis. It is indicated for hormone-dependent conditions including prostate cancer, endometriosis, and uterine fibroids. The drug works through initial stimulation followed by continuous suppression of sex hormone production, reversible upon discontinuation.
Peak
Product is at peak commercial maturity with moderate competitive pressure (30%), suggesting stable team size but potential for defensive market strategies.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty
Started Mar 2023
80 enrolled
Central Precocious Puberty
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
Started Jul 2021
250 enrolled
Breast Cancer
Leuprolide Acetate 3.75 mg Depot Injection for Patients With Advanced Prostate Cancer
Started Jul 2021
155 enrolled
Advanced Prostate Adenocarcinoma
A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
Started Oct 2018
45 enrolled
Central Precocious Puberty (CPP)
Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
Started Aug 2015
64 enrolled
Precocious Puberty, Central
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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.