Last Updated: August 9, 2026

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. Six 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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Summary for CETROTIDE
Recent Clinical Trials for CETROTIDE

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

SponsorPhase
Trust Fertility ClinicPHASE4
Beni-Suef UniversityPHASE3
Mỹ Đức HospitalNA

See all CETROTIDE clinical trials

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Emd Serono Inc CETROTIDE cetrorelix acetate POWDER;SUBCUTANEOUS 021197-002 Aug 11, 2000 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 021197-002 Aug 11, 2000 4,800,191 ⤷  Start Trial
Emd Serono Inc CETROTIDE cetrorelix acetate POWDER;SUBCUTANEOUS 021197-001 Aug 11, 2000 4,800,191 ⤷  Start Trial
Emd Serono Inc CETROTIDE cetrorelix acetate POWDER;SUBCUTANEOUS 021197-001 Aug 11, 2000 6,319,192 ⤷  Start Trial
Emd Serono Inc CETROTIDE cetrorelix acetate POWDER;SUBCUTANEOUS 021197-001 Aug 11, 2000 7,605,121 ⤷  Start Trial
Emd Serono Inc CETROTIDE cetrorelix acetate POWDER;SUBCUTANEOUS 021197-002 Aug 11, 2000 7,605,121 ⤷  Start Trial
Emd Serono Inc CETROTIDE cetrorelix acetate POWDER;SUBCUTANEOUS 021197-001 Aug 11, 2000 6,863,891 ⤷  Start Trial
Emd Serono Inc CETROTIDE cetrorelix acetate POWDER;SUBCUTANEOUS 021197-002 Aug 11, 2000 5,198,533 ⤷  Start Trial
>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/000233Prevention 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
Austria 90362 ⤷  Start Trial
Brazil 1100478 ⤷  Start Trial
Canada 1339623 ANTAGONISTE DE LA LUBERINE (LHRH ANTAGONISTS) ⤷  Start Trial
Germany 19975052 ⤷  Start Trial
Germany 3823590 ⤷  Start Trial
Germany 3881592 ⤷  Start Trial
Denmark 173375 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CETROTIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0299402 C990029 Netherlands ⤷  Start Trial 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 099C0031 Belgium ⤷  Start Trial PRODUCT NAME: ACETATE DE CETRORELIX; REGISTRATION NO/DATE: EU/1/99/100/001 19990413
0299402 31/1999 Austria ⤷  Start Trial PRODUCT NAME: CETRORELIX UND PHARMAZEUTISCH ANNEHMBARE SAEUREADDITIONSSALZE DAVON, INSBESONDERE CETRORELIXACETAT; REGISTRATION NO/DATE: EU/1/99/100/001- EU/1/99/100/003 19990413
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Last updated: July 30, 2026

CETROTIDE (cetrotide/cetrotide?) market dynamics and financial trajectory: sales trends, exclusivity overhang, and competitive pressure

No complete, reliable market-and-financial dataset for “CETROTIDE” could be produced from the available information.

What is CETROTIDE and which indication drives sales?

Answer: Not available.

Which active ingredient and dosage forms are marketed under the name “CETROTIDE”?

Not available.

Does CETROTIDE have multiple presentations that change unit economics?

Not available.

How has CETROTIDE’s revenue trended over time (US, EU, and ex-US)?

Answer: Not available.

What are the reported sales by year and by geography?

Not available.

What is the revenue mix across dose strengths and pack sizes?

Not available.

What market dynamics are shaping CETROTIDE demand (IVF stimulation, payer mix, and channel behavior)?

Answer: Not available.

How do IVF cycle volumes and prescribing patterns affect CETROTIDE volumes?

Not available.

What tendering, formulary placement, and reimbursement levers affect net price?

Not available.

Is CETROTIDE facing substitution to competing gonadotropin-releasing hormone (GnRH) antagonists?

Not available.

What does the competitive landscape look like for CETROTIDE (brands, generics, and authorized substitutes)?

Answer: Not available.

Which competitors drive cross-price elasticity in IVF protocols?

Not available.

Are there biosimilar-style dynamics or small-molecule generic substitution risks?

Not available.

How strong is CETROTIDE’s patent and exclusivity moat, and when does it erode?

Answer: Not available.

When does CETROTIDE lose regulatory exclusivity (if applicable)?

Not available.

What is the expected timeline for generic entry risk?

Not available.

What does FDA and European regulatory status imply for launch/competition timing?

Answer: Not available.

What is the FDA approval pathway and labeling scope?

Not available.

What is the EMA approval status and any major label changes?

Not available.

What Orange Book status applies to CETROTIDE, and what Paragraph IV threats exist?

Answer: Not available.

Is CETROTIDE listed with patents that would constrain generic entry?

Not available.

Have any Paragraph IV certifications been filed (or settlements announced)?

Not available.

How does CETROTIDE compare with alternative IVF drug classes in cost and utilization (clinical-adjacent market economics)?

Answer: Not available.

How does total treatment cost differ versus competing antagonist or agonist protocols?

Not available.

What is the financial trajectory under realistic scenarios (base, downside, upside)?

Answer: Not available.

Base case drivers

Not available.

Downside case drivers (price erosion, supply shocks, lost formulary placement)

Not available.

Upside case drivers (indication expansion, protocol adoption, payer coverage gains)

Not available.

Key Takeaways

Not available.

FAQs

Not available.

References (APA)

Not available.

More… ↓

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