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Last Updated: November 21, 2024

Cetrorelix acetate - Generic Drug Details


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What are the generic drug sources for cetrorelix acetate and what is the scope of freedom to operate?

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
Drug Prices for cetrorelix acetate

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Recent Clinical Trials for cetrorelix acetate

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

SponsorPhase
Northwest Women's and Children's Hospital, Xi'an, ShaanxiN/A
Bezmialem Vakif UniversityN/A
Bio Genuine (Shanghai) Biotech Co., Ltd.Phase 2

See all cetrorelix acetate clinical trials

US Patents and Regulatory Information for cetrorelix acetate

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 021197-002 Aug 11, 2000 DISCN Yes 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
Qilu CETRORELIX ACETATE cetrorelix acetate POWDER;SUBCUTANEOUS 217776-001 Apr 16, 2024 AP RX No No ⤷  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
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
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 021197-001 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 021197-002 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 021197-002 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

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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