GONAL-F RFF Drug Profile

Summary for Tradename: GONAL-F RFF

High Confidence Patents:	9
Applicants:	1
BLAs:	2

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for GONAL-F RFF Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for GONAL-F RFF Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Emd Serono, Inc.	GONAL-F RFF	follitropin alfa	For Injection	021765	10,016,338	2036-12-20	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF	follitropin alfa	For Injection	021765	10,154,856	2034-02-06	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF	follitropin alfa	For Injection	021765	10,577,154	2038-12-19	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF	follitropin alfa	For Injection	021765	5,767,067	2015-06-16	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF	follitropin alfa	For Injection	021765	5,767,251	2013-01-22	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF	follitropin alfa	For Injection	021765	7,446,090	2026-07-07	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for GONAL-F RFF Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Emd Serono, Inc.	GONAL-F RFF	follitropin alfa	For Injection	021765	10,016,338	2036-12-20	Patent claims search
Emd Serono, Inc.	GONAL-F RFF	follitropin alfa	For Injection	021765	10,154,856	2034-02-06	Patent claims search
Emd Serono, Inc.	GONAL-F RFF	follitropin alfa	For Injection	021765	10,577,154	2038-12-19	Patent claims search
Emd Serono, Inc.	GONAL-F RFF	follitropin alfa	For Injection	021765	10,912,714	2038-07-09	Patent claims search
Emd Serono, Inc.	GONAL-F RFF	follitropin alfa	For Injection	021765	10,953,073	2038-09-17	Patent claims search
Emd Serono, Inc.	GONAL-F RFF	follitropin alfa	For Injection	021765	11,298,293	2041-01-15	Patent claims search

International Patents for GONAL-F RFF

Country	Patent Number	Estimated Expiration
Germany	211894
Australia	2011252925
Japan	H09173064
Canada	2892294
South Africa	201300242
Australia	776823

Supplementary Protection Certificates for GONAL-F RFF

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SPC/GB10/010	United Kingdom		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTERED: UK EU/1/09/609/001 20100125; UK EU/1/09/609/002 20100125
96C0010	Belgium		PRODUCT NAME: FOLLITROPINE ALPHA; NAT. REGISTRATION NO/DATE: EU1/95/001/001 19951020; FIRST REGISTRATION: FI 11529 19940815
122010000006	Germany		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
300049	Netherlands		300049, 20041031, EXPIRES: 20091030
SPC/GB96/011	United Kingdom		PRODUCT NAME: RECOMBINANT HUMAN FOLLICLE STIMULATING HORMONE; REGISTERED: FI 11529 19940815; FI 11530 19940815; UK EU/1/95/001 19951020; UK EU/1/95/002 19951020; UK EU/1/95/003 19951020; UK EU/1/95/004 19951020; UK EU/1/95/005 19951020; UK EU/1/95/006 19951020; UK EU/1/95/007 19951020; UK EU/1/95/008 19951020; UK EU/1/95/009 19951020; UK EU/1/95/010 19951020; UK EU/1/95/011 19951020; UK EU/1/95/012 19951020; UK EU/1/95/013 19951020; UK EU/1/95/014 19951020; UK EU/1/95/015 19951020; UK EU/1/95/016 19951020
3/2010	Austria		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125

Market Dynamics and Financial Trajectory for the Biologic Drug: GONAL-F RFF

Last updated: September 19, 2025

Introduction

GONAL-F RFF (recombinant follicle-stimulating hormone) represents a significant segment within the reproductive health pharmaceutical market. Developed by Merck KGaA (sold under EMD Serono in the U.S.), this biologic agent is primarily prescribed for fertility treatments such as controlled ovarian hyperstimulation in women undergoing assisted reproductive technology (ART). Its market dynamics and financial trajectory are shaped by evolving regulatory landscapes, demographic trends, technological innovations, and competitive pressures.

Market Overview

The global fertility drugs market, where GONAL-F RFF operates, is experiencing sustained growth, driven by increasing infertility prevalence, advancements in reproductive science, and expanding awareness of ART options. According to Grand View Research, the global fertility drugs market was valued at approximately USD 5.5 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of around 10% through 2030 [1].

GONAL-F RFF holds a substantial market share within this sector due to its long-standing reputation for efficacy, safety profile, and favorable administration dosing. The biologic's broad indications, including controlled ovarian stimulation and ovulation induction, make it a versatile agent in fertility treatment protocols.

Market Dynamics Influencing GONAL-F RFF

Demographic and Epidemiological Trends

Infertility impacts approximately 10-15% of couples globally, with prevalence rising due to lifestyle factors, delayed childbearing, and environmental influences [2]. Aging maternal populations and increased awareness about fertility preservation strategies expand the potential patient base. Developed markets like North America and Europe exhibit stable demand driven by these demographic shifts, while emerging markets show growth potential facilitated by expanding healthcare infrastructure.

Regulatory Environment

Regulatory pathways for biologics like GONAL-F RFF are well-established in developed regions, fostering market stability. However, biosimilar regulations and generic competition are emerging challenges. The approval of biosimilar alternatives, particularly in Europe and Asia, could pressure pricing and market share, necessitating continuous innovation and patent protections.

Technological Innovations and Differentiation

Advances in recombinant DNA technology have enhanced the purity, consistency, and safety of GONAL-F RFF, reinforcing its market position. Innovations such as prefilled syringes, pen devices, and patient-centric delivery systems improve compliance and treatment outcomes. The integration of new indications, such as ovulation induction in polycystic ovary syndrome (PCOS), further broadens its applicability.

Competitive Landscape

GONAL-F RFF faces competition from biosimilars like Bemfola (GSK/Korea's GC Pharma) and Ovapred (Sandoz), which threaten price margins and market share. Additionally, alternative fertility agents, including recombinant luteinizing hormone (rLH) and human menopausal gonadotropins, influence prescribing patterns. Innovative products, such as combination protocols and personalized medicine approaches, are redefining competitive positioning.

Pricing and Reimbursement Dynamics

Pricing strategies are critical; GONAL-F RFF’s premium status in markets with favorable reimbursement frameworks sustains its profitability. However, healthcare reforms promoting cost containment exert pressure on pricing, especially in regions like Europe and emerging markets. Payer negotiations and formulary placements significantly impact sales trajectories.

Financial Trajectory

Revenue Trends

Since its launch in the early 2000s, GONAL-F RFF has demonstrated steady revenue growth driven by ongoing demand in fertility clinics worldwide. Pre-pandemic, revenues were estimated to be over USD 1 billion annually, with growth rates sustained through expanding indications and geographic reach [3].

The COVID-19 pandemic temporarily disrupted fertility treatments, leading to dips in short-term sales. However, the market rebounded swiftly, with clinics resuming procedures and research institutions advancing personalized reproductive medicine.

Investment and R&D Outlook

Continued investments in R&D are vital to maintain a competitive edge. Merck KGaA announced pipeline expansions involving next-generation formulations, improved delivery systems, and combination therapies to address unmet clinical needs and emerging market demands.

Market Penetration in Emerging Economies

Growth strategies are focusing on expanding access in Asia-Pacific, Latin America, and Middle East regions, where fertility awareness and healthcare investments are increasing. Local manufacturing, strategic partnerships, and regulatory collaborations underpin these expansion efforts.

Impact of Biosimilars and Patent Expirations

Patent expirations in major markets are expected to introduce biosimilar competitors over the next 3-5 years. While this may initially compress price points, GONAL-F RFF’s brand equity and clinical familiarity provide resilience. Merck’s strategy includes lifecycle management—developing new formulations and securing new indications—to offset generic competition.

Regulatory and Commercial Risks

Potential risks include delays in regulatory approvals for new formulations, pricing reforms, and changes in reimbursement policies. Additionally, competition from biosimilars and alternative fertility modalities could limit growth trajectories.

Future Outlook and Strategic Considerations

The outlook for GONAL-F RFF remains cautiously optimistic. Key aspects to monitor include:

• Pipeline Development: Innovations in administration (e.g., oral or less invasive options) and combination therapies.
• Market Expansion: Penetration of emerging markets through localized manufacturing and partnerships.
• Pricing Strategies: Navigating pricing regulations and securing favorable reimbursement terms.
• Regulatory Approvals: Expanding indications based on clinical evidence to increase patient applicability.
• Biosimilar Competition: Differentiation through biosimilar management and patent strategies.

Key Takeaways

• Growing Market: The global fertility drugs market is projected to expand at a CAGR of approximately 10%, underpinning sustained demand for GONAL-F RFF.
• Demographic Drivers: Increasing infertility rates and delayed childbearing enhance market opportunities.
• Competitive Pressures: Biosimilars and alternative therapies will require strategic innovation and lifecycle management.
• Regional Expansion: Emerging markets present growth prospects, contingent on tailored regulatory and pricing strategies.
• Innovation Focus: R&D investments in formulations and indications will sustain product relevance amid competitive and regulatory challenges.
• Financial Stability: Steady revenue generation is expected, bolstered by a strong regulatory position and diverse indications, despite market disruptions.

In conclusion, GONAL-F RFF’s market dynamics are characterized by robust demand within a growing fertility drugs sector, nuanced by competitive and regulatory challenges. Its future financial trajectory will depend on strategic innovation, geographic expansion, and effective lifecycle management amid a landscape of evolving healthcare policies and biosimilar considerations.

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FAQs

1. How does GONAL-F RFF compare to biosimilar alternatives in terms of efficacy and safety?
GONAL-F RFF benefits from extensive clinical trial data confirming its efficacy and safety, establishing a high level of physician confidence. Biosimilars, while approved based on demonstrated similarity, may lack the same clinical familiarity, although they generally offer comparable therapeutic results at lower prices.

2. What strategies can Merck KGaA adopt to maintain GONAL-F RFF’s market share amid biosimilar competition?
Merck can focus on innovation through new formulations, expand indications, strengthen patents, and deepen relationships with fertility clinics. Investing in personalized treatment protocols and patient adherence solutions also solidifies brand loyalty.

3. Which emerging markets offer the greatest growth potential for GONAL-F RFF?
Asia-Pacific, Latin America, and Middle East regions hold significant upside, driven by increasing healthcare investments, rising infertility awareness, and expanding fertility clinics.

4. What regulatory hurdles could impact GONAL-F RFF's future sales?
Regulatory delays in approval of new indications or formulations and stringent reimbursement reforms could constrain sales. Biosimilar approvals, especially in markets with aggressive biosimilar policies, also pose risks.

5. How will technological innovations impact the future of GONAL-F RFF?
Advances such as patient-friendly delivery systems, integration with digital health monitoring, and combination therapies could enhance treatment outcomes, differentiate the product, and sustain market relevance.

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References

[1] Grand View Research. Fertility Drugs Market Size, Share & Trends Analysis Report, 2021-2030.
[2] WHO. Infertility facts and figures.
[3] Merck KGaA investor reports and market analyses, 2022.