CETROTIDE Drug Patent Profile
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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. Seven 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 12th, 2022.
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Questions you can ask:
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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: | 4,270 |
| Drug Prices: | Drug price information for CETROTIDE |
| What excipients (inactive ingredients) are in CETROTIDE? | CETROTIDE excipients list |
| DailyMed Link: | CETROTIDE at DailyMed |
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 |
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 | ⤷ 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 CETROTIDE
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for CETROTIDE
See the table below for patents covering CETROTIDE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 0947200 | Compositions comprennant l'acĂ©tate de cetrorelix pour le traitement de l'infertilitĂ© chez les femmes et la protection des gonades (Compositions comprising Cetrorelix acetate for the treatment of female infertility and gonadal protection) | ⤷ Sign Up |
| Slovenia | 9400087 | NOVEL PROCESS FOR THE PREPARATION OF CETRORELIX LYOPHILISATE | ⤷ Sign Up |
| European Patent Office | 0299402 | LHRH ANTAGONISTS, THEIR MANUFACTURE AND PHARMACEUTICAL COMPOSITIONS THEREOF | ⤷ Sign Up |
| Russian Federation | 2145234 | PEPTIDE-BASED LYOPHILIZATE AND METHOD OF PREPARATION THEREOF | ⤷ Sign Up |
| Finland | 110059 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CETROTIDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0299402 | 099C0031 | Belgium | ⤷ Sign Up | PRODUCT NAME: ACETATE DE CETRORELIX; REGISTRATION NO/DATE: EU/1/99/100/001 19990413 |
| 0299402 | 31/1999 | Austria | ⤷ Sign Up | 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 | C990029 | Netherlands | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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