NDASUBCUTANEOUSPOWDER1 Generic Approved
Approved
Feb 2003
Lifecycle
Peak
Competitive Pressure
15/100
Clinical Trials
9
Data completeness
4/8 — Partial
Drug data last refreshed 2d ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ELIGARD KIT is a subcutaneous powder formulation of leuprolide acetate, a GnRH agonist approved in 2003 for hormone-responsive cancers and benign prostatic hyperplasia. It works by suppressing luteinizing hormone and follicle-stimulating hormone, leading to reduced sex hormone production. The product is currently in peak lifecycle stage with 15.5 years of patent protection remaining.
Peak15.5 years to LOE
Established product in peak revenue stage with 15 competitors creating moderate pricing pressure; expect stable team size focused on market maintenance and account management rather than growth initiatives.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
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.