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:	59
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
Trust Fertility Clinic	PHASE4
Beni-Suef University	PHASE3
Mỹ Đức Hospital	NA

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	021197-001	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-001	Aug 11, 2000

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
Poland	177177
Hungary	206376	PROCESS FOR PRODUCING LH-RH ANTAGONISTS AND PHARMACEUTICAL COMPOSITIONS COMPRISING SAME
Poland	343609
Slovenia	1082129
Hungary	228736	USE OF LHRH ATNAGONISTS IN THE PRODUCTION OF PHARMACEUTICAL COMPOSTION FOR THE TREATMENT OF FERTILITY DISORDERS
Austria	193653

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	099C0031	Belgium		PRODUCT NAME: ACETATE DE CETRORELIX; REGISTRATION NO/DATE: EU/1/99/100/001 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

CETROTIDE: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

What is CETROTIDE and Its Therapeutic Role?

CETROTIDE (cetrorelix acetate) is a synthetic decapeptide analog of gonadotropin-releasing hormone (GnRH) antagonist. It is marketed as a prescription medication for use in assisted reproductive technology (ART). Its primary function is to prevent premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation. By antagonizing GnRH receptors in the pituitary gland, CETROTIDE suppresses the pulsatile release of LH, which is critical for preventing premature ovulation and allowing for the optimal maturation of multiple follicles. This mechanism directly contributes to improved outcomes in in vitro fertilization (IVF) and other ART procedures. The drug is administered subcutaneously.

What is the Current Market Landscape for CETROTIDE?

The market for GnRH antagonists, including CETROTIDE, is driven by the growing global demand for ART. This demand is influenced by increasing infertility rates, delayed childbearing, and the broader acceptance of fertility treatments. The competitive landscape includes other GnRH antagonists and GnRH agonists, which can be used as alternatives or in different protocols.

Key players in the GnRH antagonist market include:

• Merck KGaA (for Gonal-f®, which is used in conjunction with GnRH antagonists like CETROTIDE)
• Merck & Co. (marketed as Ganirelix® in some regions, a direct competitor)
• AbbVie Inc. (marketed as Lupron Depot®, a GnRH agonist often used in ART)
• Ferring Pharmaceuticals (manufacturer of CETROTIDE)
• Various generic manufacturers are also entering or have entered the market, increasing price competition.

The market is characterized by significant patent protections, followed by the eventual emergence of generic alternatives. The regulatory environment, governed by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), plays a crucial role in market access and product approval.

What is the Development and Patent History of CETROTIDE?

CETROTIDE was developed by Ares Serono, which was later acquired by Serono Group. Serono Group was then acquired by Merck KGaA in 2007. The development focused on creating a GnRH antagonist with a favorable pharmacokinetic profile for ART protocols.

Key Patent Information:

• Composition of Matter Patents: These patents would have covered the specific chemical structure of cetrorelix acetate. The initial patent filings and grants for the core compound would have expired decades ago. For example, foundational patents related to GnRH antagonists were filed in the late 1980s and early 1990s.
• Formulation Patents: Patents protecting specific formulations, dosages, or delivery methods of CETROTIDE. These extend market exclusivity beyond the original composition of matter patents.
• Method of Use Patents: Patents covering specific treatment protocols or patient populations for which CETROTIDE is indicated.
• Manufacturing Process Patents: Patents protecting the methods used to synthesize or purify cetrorelix acetate.

Exclusivity and Generic Entry:

The original patents for CETROTIDE have largely expired, paving the way for generic competition. Ferring Pharmaceuticals, the current marketer, faces competition from generic versions of cetrorelix acetate. For instance, reports indicate generic versions became available in the U.S. around 2017-2018 and in Europe shortly thereafter. The expiration of key patents allows other pharmaceutical companies to manufacture and market their own versions of cetrorelix acetate, leading to price erosion.

What is the Historical Financial Performance of CETROTIDE?

Analyzing the precise historical financial performance of CETROTIDE as a standalone product is challenging due to reporting practices. Pharmaceutical companies often report sales for therapeutic categories or larger drug portfolios rather than individual drug revenues, especially for mature products. However, trends in the ART market and competitor performance can provide indirect insights.

General Market Trends and Implied Performance:

• Growth in ART Market: The global ART market has shown consistent year-over-year growth. The World Health Organization (WHO) estimates that approximately 2-3% of all births globally are conceived through ART. This expanding market base directly benefits drugs like CETROTIDE.
• Competition: The introduction of generic cetrorelix acetate has likely impacted the revenue generated by brand-name CETROTIDE. However, the overall volume of GnRH antagonist usage may have increased due to lower generic prices, potentially stabilizing or even growing the total market value for the drug class.
• Portfolio Contribution: For Ferring Pharmaceuticals, CETROTIDE (and its generic competitors) contributes to their reproductive health and fertility portfolio, which is a significant area of focus for the company. While specific revenue figures for CETROTIDE are not publicly disclosed, it remains a standard treatment option in ART cycles.

Estimated Market Size for GnRH Antagonists:

While precise figures for CETROTIDE are not available, the broader GnRH antagonists market, which includes CETROTIDE and its direct competitors like ganirelix, is estimated to be in the hundreds of millions of dollars globally. The market for fertility drugs, including GnRH modulators, is projected to continue growing. For example, some market research reports estimated the global fertility drugs market at USD 2.5 billion in 2022, with a compound annual growth rate (CAGR) of approximately 4-5% expected through 2030. GnRH antagonists are a significant segment within this market.

What are the Current and Projected Financial Projections for CETROTIDE?

Current financial projections for CETROTIDE are largely influenced by the dynamics of generic competition and the sustained growth of the ART market.

Key Financial Drivers:

• Generic Competition: The presence of multiple generic manufacturers has led to significant price reductions for cetrorelix acetate. This impacts the revenue of the original brand and puts pressure on pricing for all manufacturers.
• Market Penetration: Despite generic entry, CETROTIDE (both branded and generic forms) continues to be a widely prescribed option due to its established efficacy and inclusion in many ART protocols.
• ART Market Expansion: The underlying growth in ART cycles globally provides a constant demand base. Factors such as increasing awareness of infertility, advancements in ART technology, and improved success rates contribute to this growth.
• Geographic Expansion: While mature markets like the U.S. and Europe have established generic competition, emerging markets may still represent opportunities for both branded and generic CETROTIDE.
• Regulatory Landscape: Changes in reimbursement policies or regulatory approvals for new ART techniques could indirectly affect demand.

Financial Outlook:

The financial outlook for CETROTIDE is characterized by stable but potentially declining brand revenue due to generic erosion, offset by increasing volume of generic sales. The overall market for cetrorelix acetate is expected to maintain modest growth, driven by the ART market expansion.

• Year-over-Year Revenue: Branded CETROTIDE revenue is likely experiencing a decline. However, the aggregate revenue for all cetrorelix acetate products (branded and generic) is projected to remain robust due to volume increases.
• Profitability: Profit margins for generic manufacturers are typically lower than for the innovator but are offset by higher sales volumes. Ferring Pharmaceuticals’ profitability from CETROTIDE will depend on its strategy regarding branded versus authorized generic sales and its overall market share.

Projected Market Value:

The market value for cetrorelix acetate is difficult to isolate from the broader GnRH antagonist segment. However, given its established position and the continued growth of ART, the combined market for cetrorelix acetate is likely to remain a significant contributor to the fertility drug sector. Projections for the broader fertility drugs market suggest continued growth, implying sustained demand for effective treatments like cetrorelix acetate.

What are the Risks and Opportunities Associated with CETROTIDE?

Risks:

• Intensifying Generic Competition: The market for cetrorelix acetate is highly competitive with numerous generic manufacturers. This can lead to aggressive price wars, further compressing profit margins and reducing overall market value for the drug class.
• Development of New ART Technologies: Advancements in ART, such as alternative stimulation protocols or entirely new drug classes, could potentially reduce the reliance on GnRH antagonists like CETROTIDE.
• Reimbursement Challenges: In some healthcare systems, reimbursement for fertility treatments and associated medications can be variable or subject to restrictions, impacting patient access and demand.
• Regulatory Scrutiny: Like all pharmaceuticals, CETROTIDE is subject to ongoing regulatory oversight, including post-market surveillance for safety and efficacy.
• Patent Expirations of Ancillary Products: While CETROTIDE patents have expired, any patents on its co-administered companion drugs could indirectly impact its use if those companion drugs become more expensive or unavailable.

Opportunities:

• Growing ART Market: The persistent increase in global infertility rates and the demand for fertility treatments present a consistent and growing market opportunity for CETROTIDE.
• Emerging Markets: Developing countries with increasing access to healthcare and a growing middle class represent expansion opportunities for both branded and generic versions of CETROTIDE.
• Combination Therapies and Protocol Optimization: Research into optimizing ART protocols may identify new ways to use CETROTIDE in combination with other drugs, potentially enhancing its clinical utility and market position.
• Cost-Effectiveness of Generics: The availability of affordable generic cetrorelix acetate can increase its adoption in cost-sensitive markets and within public healthcare systems.
• Focus on Reproductive Health: Pharmaceutical companies with a strong focus on reproductive health, like Ferring Pharmaceuticals, can leverage their expertise and existing market presence to maintain or grow their share in the cetrorelix acetate market.

Key Takeaways

• CETROTIDE is a critical GnRH antagonist used in assisted reproductive technology (ART) to prevent premature LH surges.
• The market for CETROTIDE is directly tied to the growing global demand for ART, driven by increasing infertility rates and acceptance of fertility treatments.
• Original composition of matter patents for cetrorelix acetate have expired, leading to significant generic competition and price erosion for the branded product.
• While branded CETROTIDE revenue is likely declining, the overall market volume for cetrorelix acetate (including generics) is sustained by ART market growth.
• Key risks include intensified generic competition and the potential emergence of new ART technologies.
• Opportunities lie in the expanding ART market, particularly in emerging economies, and in optimizing its use within ART protocols.

Frequently Asked Questions

1. What is the primary mechanism of action for CETROTIDE in ART cycles? CETROTIDE acts as a GnRH antagonist, blocking GnRH receptors in the pituitary gland to suppress LH release, thereby preventing premature ovulation.

2. How has the introduction of generic CETROTIDE impacted its market? The introduction of generic cetrorelix acetate has led to substantial price reductions and increased competition, affecting the revenue of branded CETROTIDE but potentially increasing overall usage volume.

3. Which pharmaceutical companies are key players in the GnRH antagonist market, and how do they relate to CETROTIDE? Ferring Pharmaceuticals manufactures CETROTIDE. Merck & Co. markets ganirelix (a direct competitor), and AbbVie markets Lupron Depot (a GnRH agonist used in ART).

4. What are the major factors driving the growth of the market for drugs like CETROTIDE? The primary drivers are increasing global infertility rates, delayed childbearing, advancements in ART technology, and growing acceptance of fertility treatments.

5. What is the projected future outlook for the market specifically for cetrorelix acetate? The market for cetrorelix acetate is projected for stable but modest growth, largely driven by the expanding ART market, with generic versions continuing to capture significant market share.