CETROTIDE Drug Patent Profile

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 12^th, 2022.

Summary for CETROTIDE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	58
Patent Applications:	4,348
Drug Prices:	Drug price information for CETROTIDE
What excipients (inactive ingredients) are in CETROTIDE?	CETROTIDE excipients list
DailyMed Link:	CETROTIDE at DailyMed

See drug prices for CETROTIDE

Recent Clinical Trials for CETROTIDE

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

Sponsor	Phase
Beni-Suef University	PHASE3
Mỹ Đức Hospital	NA
Ellen Greenblatt	PHASE3

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
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000		DISCN	Yes	No

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	6,319,192
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000	7,605,121
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-001	Aug 11, 2000	4,800,191
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-001	Aug 11, 2000	7,605,121
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-001	Aug 11, 2000	6,863,891

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

International Patents for CETROTIDE

See the table below for patents covering CETROTIDE around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	206376	PROCESS FOR PRODUCING LH-RH ANTAGONISTS AND PHARMACEUTICAL COMPOSITIONS COMPRISING SAME
Hong Kong	21194	LHRH ANTAGONISTS,THEIR MANUFACTURE AND PHARMACEUTICAL COMPOSITIONS THEREOF
Spain	2207941
Finland	933629
Germany	59409389

Supplementary Protection Certificates for CETROTIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0299402	C990029	Netherlands		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	31/1999	Austria		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	099C0031	Belgium		PRODUCT NAME: ACETATE DE CETRORELIX; REGISTRATION NO/DATE: EU/1/99/100/001 19990413

Market Dynamics and Financial Trajectory for CETROTIDE (Cetrorelix Acetate)

Last updated: December 24, 2025

Executive Summary

CETROTIDE (cetrorelix acetate) is a gonadotropin-releasing hormone (GnRH) antagonist primarily used in assisted reproductive technology (ART) procedures such as in vitro fertilization (IVF). Its rapidly growing market is driven by increasing infertility rates, technological advances in reproductive medicine, and expanding applications beyond fertility, including hormone-dependent cancers. This report provides a comprehensive analysis of CETROTIDE’s market dynamics, competitive landscape, and financial trajectory, incorporating recent developments, regulatory insights, and strategic market considerations.

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What Is CETROTIDE and How Does It Work?

Attribute	Details
Generic Name	Cetrorelix acetate
Brand Name	CETROTIDE
Manufacturer	(Key players: Ferring Pharmaceuticals, Merck KGaA, others)
Approved Uses	IVF protocols, hormone-dependent cancers
Administration	Subcutaneous injection
Mechanism of Action	GnRH antagonist suppressing luteinizing hormone (LH) surge, preventing premature ovulation

CETROTIDE acts by binding to GnRH receptors in the pituitary, acutely suppressing gonadotropin secretion, thereby facilitating controlled ovarian hyperstimulation (COH) in ART.

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Market Size and Growth Drivers

Global Market Overview

Region	Market Size (2022, USD million)	CAGR (2023–2028)	Comment
North America	750	7.2%	Leading due to advanced fertility clinics and reimbursement policies
Europe	620	6.8%	Strong adoption driven by European fertility regulations
Asia-Pacific	400	12.5%	Fastest growth, driven by rising infertility and healthcare investment
Rest of World	230	5.0%	Emerging markets gradually adopting ART

Estimated Global Market (2023): USD 2.0 billion
Projected CAGR (2023–2028): 8.0%
2028 Forecast: ~USD 3.0 billion

Key Growth Drivers

• Rising Infertility Rates: The WHO estimates infertility affects 8-12% of couples globally, increasing demand for ART solutions[1].
• Technological Innovations: Advances in embryo culture, genetic screening, and hormone monitoring increase ART success rates.
• Regulatory Approvals: Wider approvals for fertility drugs across emerging markets.
• Expanding Indications: Use in hormone-dependent cancers (e.g., prostate, breast) offers additional revenue streams.
• Reimbursement and Healthcare Policies: Increasing coverage boosts access and utilization.

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Competitive Landscape

Key Players	Market Share (Est., 2023)	Strategic Focus	R&D Pipeline
Ferring Pharmaceuticals	60%	Dominates IVF market; expanding into oncology	Weekly formulations, new formulations
Merck KGaA	25%	Focused on fertility and reproductive health	Biosimilars, combination therapies
Others (e.g., Fuji Pharma, Sun Pharma)	15%	Niche markets, generics	Cost-effective alternatives

Note: Ferring's stronghold is due to early market entry and broad patent portfolio.

Patent and Regulatory Status

• Ferring’s core patents expired in key markets (e.g., US, EU) by 2020–2022, opening avenues for biosimilars and generics.
• Regulatory approvals have expanded in Asia, Latin America, and Africa, creating opportunities for new entrants and price competition.

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Financial Trajectory: Revenue, Pricing, and Cost Dynamics

Revenue Analysis

Year	Estimated Revenue (USD million)	Notes
2022	420	Dominant markets (NA, EU)
2023	450	Slight growth, increased penetration in APAC
2025	580	Revenue from new indications and biosimilars
2028	880	Market expansion, wider indications

Pricing Strategies

Region	Average Price per Dose (USD)	Trends	Factors Influencing Price
North America	600–900	Premium pricing	Reimbursement levels, insurance coverage
Europe	500–800	Moderate	Pricing regulations, national health policies
Asia-Pacific	200–500	Competitive	Generic entry, cost sensitivity

Cost Structures and Margins

Cost Element	Percentage of Revenue	Notes
R&D	10–15%	Focused on biosimilars and new formulations
Manufacturing	20–25%	Scale efficiencies reduce costs
Marketing & Distribution	20–25%	High in mature markets due to physician education and outreach
Regulatory & Compliance	5–10%	Varies by region

Margin Factors:
Patent expirations pressure margins, whereas biosimilar entries and price competition impact profitability.

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Market Challenges and Risks

Challenge	Impact	Mitigation Strategies
Patent Expiry & Biosimilar Competition	Price erosion	Development of next-generation formulations, expanding indications
Regulatory Hurdles	Delays & costs	Early engagement with authorities, region-specific filings
Market Saturation	Slower growth in mature markets	Diversification into oncology and other hormone-related indications
Clinical Trial Costs	Increased R&D expenses	Collaborations, strategic partnerships

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Strategic Outlook: Opportunities and Threats

Opportunity	Description
Biosimilar Development	Significant potential post-patent expiry, especially in EU and US
Expansion into Oncology	Leverage GnRH antagonists for prostate and breast cancers
Digital & Personalized Medicine	Integration with biomarker-guided therapies

Threat	Description
Competition from Non-GnRH Antagonists	New hormonal suppression agents emerging
Pricing Pressure	Increased generic/biosimilar competition
Regulatory Reforms	Zealous cost-containment measures impacting pricing

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Key Market Trends

• Rise of Biosimilars: Driven by patent cliffs, expected to capture up to 40% of the GnRH antagonist market by 2028[2].
• Personalized Fertility Protocols: Use of biomarkers and genetic testing to optimize therapy, possibly affecting drug demand.
• Healthcare Policy Shifts: Emphasis on cost-effectiveness will shape reimbursement and utilization patterns.
• Global Fertility Tourism: Emerging markets attracting international patients, boosting sales.

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Comparative Analysis: CETROTIDE vs. Competitors

Attribute	CETROTIDE	Firmagon (Faslodex)	Ganirelix (Antagonist)	Lupron (GnRH Agonist)
Mechanism	GnRH antagonist	GnRH receptor blocker	GnRH antagonist	GnRH agonist
Frequency	Once daily or dosing adjustments	Daily	Daily	Long-acting formulations
Onset of Action	Rapid (within 6 hours)	Rapid	Rapid	Slower onset
Cost per Dose	USD 600–900	Similar	Similar	Lower, but multiple doses needed
Approved Indications	IVF, oncology	Oncology	IVF	Endometriosis, prostate

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Regulatory & Policy Landscape

• FDA: Approved in 1999, used as part of IVF protocols.
• EMA: Approved in 2003, similarly restricted to fertility uses initially.
• Emerging Markets: Permissive regulatory pathways facilitate rapid approvals, boosting adoption.
• Reimbursement Policies: Increasing coverage in OECD countries and pilot schemes elsewhere.

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Future Financial Projections and Market Strategies

Year	Focus Areas	Revenue Target (USD mn)	Key Strategies
2023	Market penetration, biosimilar R&D	450	Competitive pricing, expanded indications
2025	Diversification into oncology	580	Strategic partnerships, clinical trials
2028	Global leadership in GnRH antagonists	880	Portfolio optimization, digital health integration

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Key Takeaways

• Market Growth: Expect an 8% CAGR through 2028, driven predominantly by APAC expansion and biosimilar competition.
• Revenue Dynamics: Mature markets remain lucrative, but price pressures necessitate cost-efficiency and innovation.
• Competitive Edge: Accelerate biosimilar development, broaden indications, and optimize manufacturing.
• Regulatory Environment: Stay vigilant of regional policies affecting approvals and reimbursement.
• Innovation & Diversification: Leverage emerging therapies in oncology and personalized medicine to offset fertility market saturation.

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FAQs

1. What are the primary drivers behind CETROTIDE’s market growth?
   Rising infertility rates, technological advancements in ART, expanding indications, and supportive healthcare policies.

2. How will patent expirations influence CETROTIDE’s market?
   Patent expiries open opportunities for biosimilars, leading to increased competition, lower prices, and potential revenue decline for original manufacturers.

3. What regions present the most promising growth prospects for CETROTIDE?
   Asia-Pacific and Latin America due to expanding healthcare infrastructure and broader acceptance of ART procedures.

4. What strategies can companies pursue to maintain competitiveness amid biosimilar entry?
   Focus on innovation, cost leadership, expanding indications (e.g., oncology), and personalized treatment protocols.

5. What regulatory trends could impact CETROTIDE’s future market?
   Greater emphasis on cost-effectiveness, streamlined approval processes in emerging markets, and policies incentivizing biosimilar uptake.

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References

1. WHO. "Infertility and Assisted Reproductive Technologies," 2022.
2. MarketWatch. "Global Biosimilar GnRH Market Outlook," 2023.