Leuprolide Acetate for Injectable Suspension — Competitive Intelligence Brief

Leuprolide Acetate for Injectable Suspension (Leuprolide Acetate for Injectable Suspension) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: GnRH agonist. Area: Oncology.

phase 3 GnRH agonist GnRH receptor Oncology Small molecule

Target snapshot

Leuprolide Acetate for Injectable Suspension (Leuprolide Acetate for Injectable Suspension) — Oakwood Laboratories, LLC. Leuprolide acetate is a gonadotropin-releasing hormone (GnRH) agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased testosterone and estrogen production.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Leuprolide Acetate for Injectable Suspension TARGET	Leuprolide Acetate for Injectable Suspension	Oakwood Laboratories, LLC	phase 3	GnRH agonist	GnRH receptor
Lupron	leuprorelin	Accord Healthcare S.L.U.	marketed	Gonadotropin Releasing Hormone Receptor Agonist	GnRH receptors	1985-01-01
Micronor	norethisterone	Johnson & Johnson	marketed	Progestin	GnRH receptors	1962-01-01
GnRH agonist trigger	GnRH agonist trigger	Rambam Health Care Campus	marketed	GnRH agonist	GnRH receptor
Gonadotropin-releasing Hormone Analog	Gonadotropin-releasing Hormone Analog	Rutgers, The State University of New Jersey	marketed	GnRH agonist	GnRH receptor
Relugolix + Estradiol + Norethindrone Acetate	Relugolix + Estradiol + Norethindrone Acetate	Sumitomo Pharma Switzerland GmbH	marketed	GnRH antagonist combination with hormone replacement therapy	GnRH receptor (relugolix component)
LHRHa	LHRHa	Imperial College London	marketed	LHRH agonist	LHRH receptor (GnRH receptor)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

• 2028-03-22 — Lupron · 9617303 · US
• 2031-02-05 — Lupron · 8921326 · US

Sponsor landscape (GnRH agonist class)

1. Takeda · 4 drugs in this class
2. Abbott · 3 drugs in this class
3. Ipsen · 3 drugs in this class
4. Changchun GeneScience Pharmaceutical Co., Ltd. · 3 drugs in this class
5. University of Pisa · 2 drugs in this class
6. Chong Qing Reproducive and Genetic Institute · 1 drug in this class
7. Chesapeake Urology Research Associates · 1 drug in this class
8. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · 1 drug in this class
9. Enteris BioPharma Inc. · 1 drug in this class
10. Colorado Center for Reproductive Medicine · 1 drug in this class