Gynodian® Depot (BAY86-5032) — Competitive Intelligence Brief

Gynodian® Depot (BAY86-5032) (Gynodian® Depot (BAY86-5032)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: GnRH agonist. Area: Endocrinology / Gynecology.

phase 3 GnRH agonist GnRH receptor Endocrinology / Gynecology Small molecule

Target snapshot

Gynodian® Depot (BAY86-5032) (Gynodian® Depot (BAY86-5032)) — Bayer. Gynodian Depot is a long-acting gonadotropin-releasing hormone (GnRH) agonist that suppresses luteinizing hormone and follicle-stimulating hormone to reduce estrogen levels.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Gynodian® Depot (BAY86-5032) TARGET	Gynodian® Depot (BAY86-5032)	Bayer	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
TRIPTORELIN ACETATE, hCG	TRIPTORELIN ACETATE, hCG	HaEmek Medical Center, Israel	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)
triptorelin, recombinant LH	triptorelin, recombinant LH	IVI Madrid	marketed	GnRH agonist with recombinant LH supplementation	GnRH receptor; LH receptor
COS with GnRH antagonists and HP-HMG	COS with GnRH antagonists and HP-HMG	Instituto Valenciano de Infertilidad, IVI VALENCIA	marketed	Gonadotropin protocol / Assisted reproductive technology regimen	GnRH receptor (antagonism); FSH receptor and LH receptor (agonism via exogenous gonadotropins)

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