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
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 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for cetrorelix acetate
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
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 |