NDAINTRAMUSCULARPOWDER
Approved
Apr 1993
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
7
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.
Clinical Trials (5)
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
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)
Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
Started Sep 2014
Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation
Started Dec 2012
82 enrolled
LeukemiaMultiple MyelomaMyelodysplastic Syndrome+1 more
Loss of Exclusivity
LOE Date
Feb 5, 2031
59 months away
Patent Expiry
Feb 5, 2031
Exclusivity Expiry
Apr 14, 2026