Cetrotide Injectable Product — Competitive Intelligence Brief

Cetrotide Injectable Product (Cetrotide Injectable Product) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: GnRH antagonist. Area: Reproductive/Fertility.

phase 3 GnRH antagonist GnRH receptor Reproductive/Fertility Small molecule

Target snapshot

Cetrotide Injectable Product (Cetrotide Injectable Product) — El Shatby University Hospital for Obstetrics and Gynecology. Cetrotide is a gonadotropin-releasing hormone (GnRH) antagonist that blocks GnRH receptors to suppress luteinizing hormone and follicle-stimulating hormone secretion.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Cetrotide Injectable Product TARGET	Cetrotide Injectable Product	El Shatby University Hospital for Obstetrics and Gynecology	phase 3	GnRH antagonist	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
cetrorelix (cetrotide)	cetrorelix (cetrotide)	Eugonia	marketed	GnRH antagonist	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)
Gonadotropin-releasing Hormone Analog	Gonadotropin-releasing Hormone Analog	Rutgers, The State University of New Jersey	marketed	GnRH agonist	GnRH receptor
Lupron Depot	Lupron Depot	University of Michigan Rogel Cancer Center	marketed	GnRH agonist	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 antagonist class)

1. Jiangsu HengRui Medicine Co., Ltd. · 2 drugs in this class
2. Instituto Valenciano de Infertilidad, IVI VALENCIA · 2 drugs in this class
3. AEterna Zentaris · 2 drugs in this class
4. El Shatby University Hospital for Obstetrics and Gynecology · 1 drug in this class
5. Eugonia · 1 drug in this class
6. Instituto de Investigacion Sanitaria La Fe · 1 drug in this class
7. Merck KGaA, Darmstadt, Germany · 1 drug in this class
8. Rabin Medical Center · 1 drug in this class
9. Sumitomo Pharma Switzerland GmbH · 1 drug in this class
10. University of Edinburgh · 1 drug in this class