NDAINTRAMUSCULARPOWDER
Approved
Apr 1993
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
9
Data completeness
6/8 — Strong
LUPRON DEPOT-PED KIT (leuprolide acetate) by AbbVie is acetate, a gnrh agonist, acts as a potent inhibitor of gonadotropin secretion (lh and follicle stimulating hormone (fsh)) when given continuously in therapeutic doses. Approved for central precocious puberty, prostate cancer. First approved in 1993.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LUPRON DEPOT-PED KIT is a leuprolide acetate intramuscular powder formulation that functions as a GnRH agonist, suppressing gonadotropin secretion (LH and FSH) to treat central precocious puberty and prostate cancer. The drug works by initial stimulation followed by continuous suppression of ovarian and testicular steroidogenesis, leading to tumor growth inhibition in hormone-dependent cancers.
Peak4.8 years to LOE
Product is at peak commercial maturity with significant competitive pressure (8/10) but approaching loss of exclusivity in 4.8 years, signaling likely team consolidation and transition planning.
Mechanism of Action
acetate, a GnRH agonist, acts as a potent inhibitor of gonadotropin secretion (LH and follicle stimulating hormone (FSH)) when given continuously in therapeutic doses.
Indications (2)
Clinical Trials (9)
A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty
Started Mar 2023
80 enrolled
Central Precocious Puberty
Leuprolide Acetate 3.75 mg Depot Injection for Patients With Advanced Prostate Cancer
Started Jul 2021
155 enrolled
Advanced Prostate Adenocarcinoma
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
Started Jul 2021
250 enrolled
Breast Cancer
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.