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:	48
Clinical Trials:	55
Patent Applications:	5,367
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	Phase 2/Phase 3
Bezmialem Vakif University	N/A
Zagazig University	N/A

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	7,605,121
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-001	Aug 11, 2000	7,605,121
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	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/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

International Patents for CETROTIDE

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0611572	Procédé de préparation d'une composition lyophilisée de cetrorelix (Process to prepare a cetrorelix lyophilised composition)
Hungary	T67117
Portugal	1082129

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

CETROTIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cetrotide

Introduction

Cetrotide, also known as cetrorelix acetate, is a synthetic decapeptide and a gonadotropin-releasing hormone (GnRH) antagonist. It is primarily used in the prevention of premature ovulation in patients undergoing controlled ovarian stimulation (COS) followed by assisted reproductive techniques (ART). Here, we delve into the market dynamics and financial trajectory of this drug.

Clinical Use and Efficacy

Cetrotide is a crucial component in fertility treatments, particularly in IVF procedures. It works by binding to GnRH receptors on the pituitary gland, thereby suppressing the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This suppression is dose-dependent and reversible, ensuring that ovulation is delayed until the optimal time for egg retrieval[1].

Market Size and Growth

The global market for Cetrotide is experiencing substantial growth, driven by increasing demand for fertility treatments and advancements in assisted reproductive technologies. The market is estimated to continue growing at a significant rate over the coming years, fueled by rising infertility rates and the expanding availability of fertility services[4].

Regulatory Approvals

A key milestone in the market dynamics of Cetrotide was the FDA approval of a generic version by Calyptus Pharmaceuticals in 2022. This approval for an Abbreviated New Drug Application (ANDA) for a 0.25 mg/vial formulation has broadened accessibility to the medication, potentially increasing market penetration and competition[3].

Financial Performance

The financial trajectory of Cetrotide is closely tied to its market performance and the overall demand for fertility treatments. As of 2022, U.S. sales of Cetrotide were approximately $63 million, with full-year projections indicating continued growth. The entry of generic versions is expected to impact pricing and market share, but the overall demand for the drug is likely to remain strong due to its critical role in fertility treatments[3].

Competitive Landscape

The market for GnRH antagonists, including Cetrotide, is competitive, with several players involved in the development and distribution of these drugs. The approval of generic versions, such as the one by Calyptus Pharmaceuticals, introduces new competitors and can lead to price competition, which may affect the financial performance of the original brand[3].

Pharmaceutical Company Strategies

Companies like Merck KGaA, which has been involved in the development and distribution of Cetrotide, have robust strategies to manage market dynamics. Merck focuses on innovation, mergers and acquisitions, and expanding its portfolio to maintain market leadership. The company's financial framework emphasizes disciplined capital allocation, strong free cash flow generation, and a focus on high-growth markets, including the fertility sector[2][5].

Market Trends and Drivers

Several trends drive the market for Cetrotide:

• Increasing Infertility Rates: Rising infertility rates globally are driving the demand for fertility treatments, including IVF and other assisted reproductive technologies.
• Advancements in Technology: Improvements in fertility treatments and the development of new technologies are making these procedures more accessible and effective.
• Regulatory Environment: Favorable regulatory approvals, such as the FDA approval of generic versions, are expanding market access and competition.
• Demographic Changes: Changes in family planning and delayed childbearing are contributing to the growing demand for fertility services[4].

Financial Projections

The financial trajectory for Cetrotide is expected to be positive, driven by the growing demand for fertility treatments and the expanding market for GnRH antagonists. While the entry of generic versions may impact pricing, the overall market size is projected to grow, ensuring a stable financial performance for the drug.

Key Players and Partnerships

Companies like Calyptus Pharmaceuticals and Merck KGaA play significant roles in the market for Cetrotide. Partnerships, such as the one between Calyptus and Akorn Operating Company LLC, are crucial for the distribution and marketing of the drug, especially generic versions[3].

Conclusion

The market dynamics and financial trajectory for Cetrotide are characterized by strong growth driven by increasing demand for fertility treatments, favorable regulatory approvals, and strategic company initiatives. As the market continues to expand, the financial performance of Cetrotide is expected to remain robust, despite the introduction of generic competitors.

Key Takeaways

• Growing Market Demand: Increasing infertility rates and advancements in fertility treatments drive the demand for Cetrotide.
• Regulatory Approvals: FDA approvals, including generic versions, expand market access and competition.
• Company Strategies: Merck KGaA and other companies focus on innovation, mergers and acquisitions, and strong financial management to maintain market leadership.
• Financial Performance: The drug's financial trajectory is positive, with projected growth in the market size despite competition from generic versions.
• Market Trends: Demographic changes, technological advancements, and regulatory environments are key drivers of the market.

FAQs

What is Cetrotide used for?

Cetrotide is used to prevent premature ovulation in patients undergoing controlled ovarian stimulation followed by assisted reproductive techniques (ART).

How does Cetrotide work?

Cetrotide works by binding to GnRH receptors on the pituitary gland, suppressing the secretion of LH and FSH, and thereby delaying ovulation.

What was the significance of the FDA approval for Cetrotide in 2022?

The FDA approval in 2022 was for a generic version of Cetrotide, which broadened accessibility to the medication and introduced new competition in the market.

Which companies are involved in the development and distribution of Cetrotide?

Companies like Merck KGaA and Calyptus Pharmaceuticals are involved in the development and distribution of Cetrotide.

What are the key drivers of the market for Cetrotide?

Key drivers include increasing infertility rates, advancements in fertility treatments, favorable regulatory approvals, and demographic changes.