NDAINJECTIONINJECTABLE
Approved
Oct 1990
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
12
Data completeness
5/8 — Partial
LUPRON DEPOT (leuprolide acetate) by AbbVie is long-acting gnrh analog. First approved in 1990.
Drug data last refreshed 56m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LUPRON DEPOT (leuprolide acetate) is a long-acting GnRH agonist administered as a monthly injection that suppresses pituitary gonadotropins and reduces gonadal steroid secretion. It is indicated for conditions where prolonged androgen or estrogen suppression is therapeutically beneficial, including prostate cancer, endometriosis, and uterine fibroids. The drug's effects are reversible upon discontinuation.
$129MPart D
LOE ApproachingProduct approaching loss of exclusivity with stable Medicare utilization; commercial teams should prepare for generic transition and market consolidation.
Mechanism of Action
long-acting GnRH analog. A single monthly injection of LUPRON DEPOT 3.75 mg results in an initial stimulation followed by a prolonged suppression of pituitary gonadotropins. Repeated dosing of LUPRON DEPOT 3.75 mg at monthly intervals results in decreased secretion of gonadal steroid. Consequently,…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
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.