CETROTIDE Drug Patent Profile

Which patents cover Cetrotide, and what generic alternatives are available?

Cetrotide is a drug marketed by Emd Serono Inc and is included in one NDA.

The generic ingredient in CETROTIDE is cetrorelix acetate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the cetrorelix acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cetrotide

A generic version of CETROTIDE was approved as cetrorelix acetate by TEVA PHARMS INC on August 12^th, 2022.

Summary for CETROTIDE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	55
Patent Applications:	4,690
Drug Prices:	Drug price information for CETROTIDE
What excipients (inactive ingredients) are in CETROTIDE?	CETROTIDE excipients list
DailyMed Link:	CETROTIDE at DailyMed

See drug prices for CETROTIDE

Recent Clinical Trials for CETROTIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Beni-Suef University	Phase 2/Phase 3
Bezmialem Vakif University	N/A
Zagazig University	N/A

See all CETROTIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CETROTIDE

H01CC	Anti-gonadotropin-releasing hormones
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for CETROTIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-001	Aug 11, 2000	AP	RX	Yes	Yes
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000		DISCN	Yes	No

Expired US Patents for CETROTIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-001	Aug 11, 2000

EU/EMA Drug Approvals for CETROTIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Europe B.V.	Cetrotide	cetrorelix	EMEA/H/C/000233 Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte-pick-up and assisted-reproductive techniques.In clinical trials, Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicule-stimulating hormone (FSH) suggested similar efficacy.	Authorised	no	no	no	1999-04-12

International Patents for CETROTIDE

See the table below for patents covering CETROTIDE around the world.

Country	Patent Number	Title	Estimated Expiration
Czech Republic	284314	Nový způsob výroby lyofilizátu cetrorelixu (PROCESS FOR PREPARING STERILE LYOPHILIZATE OF CETRORELIX)
Ukraine	66850	СПОСОБ ЛЕЧЕНИЯ БЕСПЛОДИЯ;СПОСІБ ЛІКУВАННЯ БЕЗПЛІДДЯ (METHOD FOR TREATING INFERTILITY)
Hungary	T67117
Slovenia	1082129

Supplementary Protection Certificates for CETROTIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0299402	C990029	Netherlands		PRODUCT NAME: CETRORELIX, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZUUR ADDITIEZOUT, IN HET BIJZONDER CETRORELIX ACETAAT; REGISTRATION NO/DATE: EU/1/99/100/001-003 19990413
0299402	31/1999	Austria		PRODUCT NAME: CETRORELIX UND PHARMAZEUTISCH ANNEHMBARE SAEUREADDITIONSSALZE DAVON, INSBESONDERE CETRORELIXACETAT; REGISTRATION NO/DATE: EU/1/99/100/001- EU/1/99/100/003 19990413
0299402	099C0031	Belgium		PRODUCT NAME: ACETATE DE CETRORELIX; REGISTRATION NO/DATE: EU/1/99/100/001 19990413