GANIRELIX ACETATE - Generic Drug Details

What are the generic sources for ganirelix acetate and what is the scope of freedom to operate?

Ganirelix acetate is the generic ingredient in two branded drugs marketed by Sun Pharm, Amphastar Pharms Inc, Gland, Lupin Ltd, Meitheal, Organon Usa Organon, Qilu, and Tris Pharma Inc, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for ganirelix acetate. Nine suppliers are listed for this compound.

Summary for GANIRELIX ACETATE

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	8
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	23
Patent Applications:	271
Drug Prices:	Drug price trends for GANIRELIX ACETATE
What excipients (inactive ingredients) are in GANIRELIX ACETATE?	GANIRELIX ACETATE excipients list
DailyMed Link:	GANIRELIX ACETATE at DailyMed

See drug prices for GANIRELIX ACETATE

Recent Clinical Trials for GANIRELIX ACETATE

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

Sponsor	Phase
University of Delaware	PHASE4
National Institute on Aging (NIA)	PHASE4
Instituto Bernabeu	Phase 4

See all GANIRELIX ACETATE clinical trials

Pharmacology for GANIRELIX ACETATE

Drug Class	Gonadotropin Releasing Hormone Receptor Antagonist
Mechanism of Action	Gonadotropin Releasing Hormone Receptor Antagonists
Physiological Effect	Decreased GnRH Secretion

Anatomical Therapeutic Chemical (ATC) Classes for GANIRELIX 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

Paragraph IV (Patent) Challenges for GANIRELIX ACETATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GANIRELIX ACETATE	Injection	ganirelix acetate	250 mcg/0.5 mL, 1 mL PFS	021057	1	2012-03-30

US Patents and Regulatory Information for GANIRELIX ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Usa Organon	GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	021057-001	Jul 29, 1999	AP	RX	Yes	Yes
Amphastar Pharms Inc	GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	212613-001	Apr 7, 2022	AP	RX	No	No
Gland	GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	215658-001	Feb 28, 2023	AP	RX	No	No
Sun Pharm	FYREMADEL	ganirelix acetate	INJECTABLE;INJECTION	204246-001	Nov 30, 2018	AP	RX	No	No

Expired US Patents for GANIRELIX ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Organon	GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	021057-001	Jul 29, 1999	4,801,577
Organon Usa Organon	GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	021057-001	Jul 29, 1999	6,653,286
Organon Usa Organon	GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	021057-001	Jul 29, 1999	5,767,082

Market Dynamics and Financial Trajectory for GANIRELIX ACETATE

Last updated: July 27, 2025

Introduction

Ganirelix acetate is a synthetic peptide used as a gonadotropin-releasing hormone (GnRH) antagonist in assisted reproductive technology (ART). Its role in preventing premature luteinizing hormone (LH) surges during controlled ovarian hyperstimulation (COH) has established it as a significant component within fertility treatments. As the global fertility market expands, understanding ganirelix acetate's market dynamics and projected financial trajectory becomes essential for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Overview

The global fertility drugs market, valued at approximately $18.5 billion in 2021, is expected to grow at a compound annual growth rate (CAGR) of 8-10% through 2028, driven by increasing infertility prevalence, demographic shifts, and technological advances. Within this landscape, gonadotropin antagonists like ganirelix acetate occupy a niche focused on controlled ovarian stimulation (COS) protocols.

Ganirelix's high specificity, favorable safety profile, and ease of administration underscore its demand. Its primary competitors include cetrorelix, elagolix, and tradenames like Ganirelix (marketed by organizations such as Merck), all vying to capture market share in fertility regimes.

Market Drivers

Rising Infertility Prevalence

Infertility affects approximately 10-15% of couples worldwide [1], with rising trends due to delayed parenthood, rising obesity, and environmental factors. This increase sustains demand for fertility pharmaceuticals, including GnRH antagonists like ganirelix acetate.

Advances in Assisted Reproductive Technologies

Technological innovations, such as in-vitro fertilization (IVF), have intensified. Ganirelix's ability to optimize ovarian response and reduce the risk of ovarian hyperstimulation syndrome (OHSS) enhances its clinical appeal, propelling growth in ART procedures.

Regulatory Approvals and Patents

Patents protecting ganirelix acetate extend into the late 2020s, providing exclusivity in major markets. Regulatory approvals from agencies like the FDA and EMA bolster commercial access, incentivizing R&D and marketing investments.

Cost-Effectiveness and Safety Profile

Being associated with fewer side effects and simplified administration routes compared to alternatives gives ganirelix a competitive edge. Cost-effectiveness analyses favor its use, especially where healthcare cost containment is prioritized.

Market Challenges

Competition and Generic Entry

Patent expirations in the upcoming years portend entry of biosimilars and generics, likely suppressing prices and reducing margins. Companies investing in first-mover advantages are poised for higher returns before generic saturation.

Pricing and Reimbursement

Pricing pressures from payers, especially in developed markets with value-based reimbursement models, challenge profit margins. National health services and private insurers seek cost-effective options, necessitating strategic pricing strategies.

Market Penetration Constraints

Limited awareness or availability in emerging markets constrains growth. Infrastructure deficits and regulatory delays slow adoption rates outside primary markets such as North America, Europe, and Asia-Pacific.

Geographic Market Dynamics

North America

Leading the global market, North America accounts for approximately 40-45% of revenue. The high incidence of infertility, technological adoption, and supportive reimbursement systems underpin this dominance. Merck's marketed ganirelix formulations enjoy widespread utilization here.

Europe

Europe constitutes about 25-30% of the market. Regulatory stability and robust healthcare systems facilitate steady adoption, though price sensitivities influence physician prescribing preferences.

Asia-Pacific

Expected to witness the highest CAGR (10-12%) owing to growing fertility awareness, rising disposable incomes, and expanding ART centers. Countries like India, China, and Japan are central to this growth trajectory.

Emerging Markets

Other regions, including Latin America and Africa, present both opportunities and challenges. While current utilization remains limited, demographic trends and increasing healthcare investments forecast significant future growth.

Financial Trajectory and Revenue Projections

Historical Performance

Historically, ganirelix acetate has demonstrated consistent growth, aligning with the broader ART market. In 2021, major pharmaceutical players recorded revenues of $300-500 million attributable to gonadotropin antagonists (including ganirelix), with Merck capturing approximately 60-70% of this share.

Volume and Pricing Trends

The increasing volume of IVF cycles, coupled with dynamic pricing strategies, supports revenue growth. Although patent protections provide pricing power, impending patent cliffs threaten future margins.

2023-2028 Forecast

• Revenue CAGR: Estimated at 8-12%, driven by market expansion and clinical adoption.
• Patent Expiry Impact: Anticipated between 2024-2026, likely leading to a decline in premium pricing, promoting generic competition.
• Post-Patent Scenario: Revenue may stabilize or decline, unless new indications or formulations are introduced.

Strategic Growth Opportunities

• Line Extensions: Developing long-acting formulations or combination therapies.
• New Indications: Exploring off-label uses or related hormonal disorders.
• Market Penetration: Targeting emerging markets with cost-effective versions.

Strategic Implications for Stakeholders

Patent Strategies and Lifecycle Management

Firms must strategize around patent expirations by investing in R&D for new formulations, delivery methods, or additional indications to extend lifecycle value.

Pricing and Reimbursement tactics

Negotiating favorable reimbursement pathways in diverse healthcare settings is vital. Tiered pricing or risk-sharing agreements can sustain profitability post-patent.

Market Expansion

Entering emerging markets through partnerships and local manufacturing enhances access and captures new revenue streams. Tailored education and marketing campaigns are necessary to increase clinician awareness.

Key Takeaways

• Ganirelix acetate remains a pivotal agent within ART protocols, benefiting from technological and clinical advantages.
• The expanding global fertility market supports sustained growth, though impending patent cliffs and competitive pressures necessitate proactive strategies.
• Geographic diversification, especially targeting emerging markets, offers significant growth potential.
• Companies should focus on lifecycle management through innovation, strategic collaborations, and market adaptation to capitalize on ganirelix acetate's financial trajectory.

Conclusion

Ganirelix acetate's market environment is characterized by moderate growth dynamics tempered by upcoming patent challenges. Its positive clinical profile ensures continued demand within developed regions, while emerging markets present lucrative opportunities. Stakeholders that strategically navigate patent management, pricing pressures, and market expansion will position themselves to capitalize on the evolving landscape, ensuring sustained revenue streams.

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FAQs

1. What are the primary clinical advantages of ganirelix acetate compared to other GnRH antagonists?
Ganirelix offers high specificity, rapid onset of action, and a favorable safety profile, reducing the risk of premature LH surge and ovarian hyperstimulation syndrome (OHSS), thereby improving ART outcomes.

2. How will patent expirations impact ganirelix acetate’s market share?
Patent expirations, expected from 2024 to 2026, could lead to biosimilar and generic introduction, exerting downward pressure on prices and margins, but also increasing access and volume.

3. Which regions are expected to drive future growth for ganirelix acetate?
Emerging markets in Asia-Pacific, particularly India and China, are anticipated to exhibit the highest growth rates, driven by expanding ART infrastructure and rising infertility prevalence.

4. How might technological innovations influence ganirelix acetate’s market trajectory?
Developments like sustained-release formulations or combination drugs could extend lifecycle, improve patient compliance, and open new indications, positively influencing revenues.

5. What strategies can companies adopt to maximize ganirelix acetate's market potential?
Firms should pursue lifecycle management, explore new indications, enhance market penetration in emerging regions, and tailor pricing strategies to local healthcare economics.

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References

1. World Health Organization. (2021). Infertility Fact Sheet.
2. MarketsandMarkets. (2022). Fertility Drugs Market Report.
3. ClinicalTrials.gov. (2022). Ongoing and Completed ART studies involving gonadotropin antagonists.
4. European Medicines Agency. (2022). Summary of Product Characteristics for Ganirelix.
5. McKinsey & Company. (2021). The Future of Fertility Care.