CETRORELIX ACETATE - Generic Drug Details

What are the generic sources for cetrorelix acetate and what is the scope of patent protection?

Cetrorelix acetate is the generic ingredient in two branded drugs marketed by Gland, Livzon Grp, Qilu, Teva Pharms Inc, and Emd Serono Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for cetrorelix acetate. Seven suppliers are listed for this compound.

Summary for CETRORELIX ACETATE

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	23
Patent Applications:	7,382
Drug Prices:	Drug price trends for CETRORELIX ACETATE
What excipients (inactive ingredients) are in CETRORELIX ACETATE?	CETRORELIX ACETATE excipients list
DailyMed Link:	CETRORELIX ACETATE at DailyMed

See drug prices for CETRORELIX ACETATE

Recent Clinical Trials for CETRORELIX ACETATE

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

Sponsor	Phase
Northwest Women's and Children's Hospital, Xi'an, Shaanxi	N/A
Bezmialem Vakif University	N/A
Bio Genuine (Shanghai) Biotech Co., Ltd.	Phase 2

See all CETRORELIX ACETATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CETRORELIX ACETATE

H01CC	Anti-gonadotropin-releasing hormones
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for CETRORELIX ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Inc	CETRORELIX ACETATE	cetrorelix acetate	POWDER;SUBCUTANEOUS	215737-001	Aug 12, 2022	AP	RX	No	No
Gland	CETRORELIX ACETATE	cetrorelix acetate	POWDER;SUBCUTANEOUS	218150-001	Apr 25, 2024	AP	RX	No	No
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-001	Aug 11, 2000	AP	RX	Yes	Yes
Qilu	CETRORELIX ACETATE	cetrorelix acetate	POWDER;SUBCUTANEOUS	217776-001	Apr 16, 2024	AP	RX	No	No
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000		DISCN	Yes	No
Livzon Grp	CETRORELIX ACETATE	cetrorelix acetate	POWDER;SUBCUTANEOUS	214540-001	Apr 24, 2024	AP	RX	No	No

Expired US Patents for CETRORELIX ACETATE

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

EU/EMA Drug Approvals for CETRORELIX ACETATE

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

CETRORELIX ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Cetrorelix Acetate

Introduction to Cetrorelix Acetate

Cetrorelix acetate, a synthetic decapeptide, is used primarily in the medical field for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation, a process crucial in assisted reproductive techniques (ART)[5].

Market Growth and Expansion

The Cetrorelix Acetate API Market has experienced a significant surge in recent years and is projected to continue this upward trend from 2023 to 2031. This robust growth is driven by several key factors:

• Increasing Demand for ART: The growing need for assisted reproductive technologies due to rising infertility rates and delayed childbearing has boosted the demand for cetrorelix acetate.
• Market Penetration: The drug's approval in various regions, including the recent FDA approval of a generic version, has expanded its market reach[2].
• Geographical Expansion: The market is segmented into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa, with each region contributing to the overall growth[1].

Segmentation and Application

The market for cetrorelix acetate is segmented based on type and application:

• Type: The drug is available in different purity levels, such as 0.98, 0.99, and others. These variations cater to different needs and applications within the pharmaceutical industry[1].
• Application: The primary applications are in medical pharmaceuticals and scientific research. The medical pharmaceutical segment is the most significant, given the drug's role in ART[1].

Financial Trajectory

The financial outlook for cetrorelix acetate is promising:

• Revenue Projections: The market size is expected to grow substantially, measured in USD million, across the forecast period from 2023 to 2031. This growth is driven by increasing demand and expanding market penetration[1].
• Sales Data: As of 2022, U.S. sales of cetrorelix acetate were approximately $63 million, with full-year projections indicating continued growth[2].

Key Drivers and Restraints

Several factors influence the market dynamics of cetrorelix acetate:

• Drivers:
  • Technological Advancements: Improvements in manufacturing processes and the development of generic versions have made the drug more accessible and affordable.
  • Regulatory Approvals: Recent FDA approvals, such as the one granted to Calyptus Pharmaceuticals, have expanded the market[2].
  • Increasing Infertility Rates: The rising need for ART due to increasing infertility rates among couples has driven up demand for cetrorelix acetate.
• Restraints:
  • Competition: The presence of other GnRH antagonists and the potential for new competitors entering the market could pose challenges.
  • Regulatory Hurdles: Stringent regulatory requirements can slow down the approval process for new formulations or generic versions.

Competitive Landscape

The competitive landscape of the cetrorelix acetate market is characterized by several key players:

• Major Companies: Companies such as Suzhou Tianma Pharma Group, Guangzhou Tosun Pharmaceutical, Shenzhen JYMed Technology, and others are prominent in the market. These companies are involved in various activities including collaborations, mergers and acquisitions, and new product introductions[1].
• Emerging Players: New entrants, such as Calyptus Pharmaceuticals, are making significant strides with FDA approvals and innovative product offerings[2].

Pharmacodynamic and Pharmacokinetic Profile

Understanding the pharmacodynamic and pharmacokinetic properties of cetrorelix acetate is crucial for its market success:

• Pharmacodynamic Effects: Cetrorelix acetate leads to a rapid and reversible suppression of serum LH, E2, and to a lesser extent FSH concentrations. This effect is dose-dependent and crucial for preventing premature ovulation in ART[3][5].
• Pharmacokinetics: The drug shows a rapid absorption profile with a short time to reach maximum plasma concentration (tmax). The elimination half-life varies depending on the dose, and the drug is metabolized by peptidases with minimal excretion in urine and bile[5].

Clinical Studies and Efficacy

Extensive clinical studies have validated the efficacy and safety of cetrorelix acetate:

• Phase II/III Studies: These studies have demonstrated the drug's ability to delay LH surges and ovulation, thereby improving the outcomes of controlled ovarian stimulation[4].
• Safety Profile: The drug has shown a positive risk-benefit ratio with no significant adverse effects reported in clinical trials[4].

Market Opportunities and Challenges

The market for cetrorelix acetate presents several opportunities and challenges:

• Opportunities:
  • Expanding into New Markets: There is potential for growth in emerging markets where access to ART is increasing.
  • Generic Versions: The approval of generic versions can increase market penetration and reduce costs for patients.
• Challenges:
  • Competition from Other GnRH Antagonists: Other drugs in the same class could compete for market share.
  • Regulatory and Economic Factors: Economic downturns and stringent regulatory environments can impact market growth.

Porter's 5 Forces Analysis

A Porter's 5 Forces analysis provides a comprehensive view of the market dynamics:

• Threat of New Entrants: Moderate due to regulatory barriers and the need for significant investment in research and development.
• Bargaining Power of Suppliers: Low to moderate as the market is dominated by a few key suppliers.
• Bargaining Power of Buyers: Moderate as buyers have some leverage due to the availability of generic versions.
• Threat of Substitute Products: Moderate as other GnRH antagonists are available.
• Competitive Rivalry Among Existing Competitors: High due to the presence of multiple players and the competitive nature of the pharmaceutical industry[1].

Key Takeaways

• The cetrorelix acetate market is experiencing rapid growth driven by increasing demand for ART and expanding market penetration.
• The drug's pharmacodynamic and pharmacokinetic profile supports its efficacy in preventing premature ovulation.
• Key players are driving innovation through collaborations and new product introductions.
• Regulatory approvals and the availability of generic versions are crucial for market expansion.
• The market faces challenges from competition and regulatory hurdles but presents significant opportunities for growth.

Frequently Asked Questions (FAQs)

Q: What is the primary use of cetrorelix acetate? A: Cetrorelix acetate is primarily used to inhibit premature LH surges in women undergoing controlled ovarian stimulation as part of assisted reproductive techniques (ART)[5].

Q: Which companies are major players in the cetrorelix acetate market? A: Major players include Suzhou Tianma Pharma Group, Guangzhou Tosun Pharmaceutical, Shenzhen JYMed Technology, and others[1].

Q: What are the key drivers of the cetrorelix acetate market? A: Key drivers include technological advancements, regulatory approvals, and increasing infertility rates[1][2].

Q: How does cetrorelix acetate affect hormone levels? A: Cetrorelix acetate leads to a rapid and reversible suppression of serum LH, E2, and to a lesser extent FSH concentrations[3][5].

Q: What is the projected market growth for cetrorelix acetate from 2023 to 2031? A: The market is expected to experience significant expansion, with substantial revenue growth projected across the forecast period[1].

Sources Cited:

1. Market Research Intellect, "Global Cetrorelix Acetate API Market Size, Scope And Forecast Report".
2. Biospace, "Calyptus Pharmaceuticals Announces FDA Approval of Cetrorelix Acetate for Injection 0.25 mg Vial".
3. PubMed, "Pharmacodynamic Effects and Plasma Pharmacokinetics of Single Subcutaneous Doses of Cetrorelix Acetate".
4. EMA, "Cetrotide, INN-Cetrorelix (as acetate)".
5. FDA, "Cetrotide® 0.25 mg (cetrorelix acetate for injection)".