CETRORELIX ACETATE - Generic Drug Details

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What are the generic sources for cetrorelix acetate and what is the scope of patent protection?

Cetrorelix acetate is the generic ingredient in two branded drugs marketed by Gland, Livzon Grp, Qilu, Teva Pharms Inc, and Emd Serono Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for cetrorelix acetate. Seven suppliers are listed for this compound.

Summary for CETRORELIX ACETATE

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	23
Patent Applications:	6,979
Drug Prices:	Drug price trends for CETRORELIX ACETATE
What excipients (inactive ingredients) are in CETRORELIX ACETATE?	CETRORELIX ACETATE excipients list
DailyMed Link:	CETRORELIX ACETATE at DailyMed

See drug prices for CETRORELIX ACETATE

Recent Clinical Trials for CETRORELIX ACETATE

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

Sponsor	Phase
Northwest Women's and Children's Hospital, Xi'an, Shaanxi	N/A
Bezmialem Vakif University	N/A
Bio Genuine (Shanghai) Biotech Co., Ltd.	Phase 2

See all CETRORELIX ACETATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CETRORELIX ACETATE

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 CETRORELIX ACETATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gland	CETRORELIX ACETATE	cetrorelix acetate	POWDER;SUBCUTANEOUS	218150-001	Apr 25, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-001	Aug 11, 2000	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Inc	CETRORELIX ACETATE	cetrorelix acetate	POWDER;SUBCUTANEOUS	215737-001	Aug 12, 2022	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Qilu	CETRORELIX ACETATE	cetrorelix acetate	POWDER;SUBCUTANEOUS	217776-001	Apr 16, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Livzon Grp	CETRORELIX ACETATE	cetrorelix acetate	POWDER;SUBCUTANEOUS	214540-001	Apr 24, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for CETRORELIX ACETATE

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

EU/EMA Drug Approvals for CETRORELIX ACETATE

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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