Follitropin beta - Biologic Drug Details

Summary for follitropin beta

Tradenames:	3
High Confidence Patents:	4
Applicants:	2
BLAs:	3
Suppliers: see list	2

Pharmacology for follitropin beta

Established Pharmacologic Class	Gonadotropin
Chemical Structure	Gonadotropins

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 brand-side disclosures

These patents were identified from searching 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 follitropin beta Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for follitropin beta 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
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2037-11-08	DrugPatentWatch analysis and company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2038-01-05	DrugPatentWatch analysis and company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2038-07-09	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for follitropin beta 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
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582		2036-12-20	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582		2036-06-14	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582		2038-12-19	Patent claims search

International Patents for follitropin beta

Country	Patent Number	Estimated Expiration
Portugal	853945
China	110074968
Argentina	082615

Supplementary Protection Certificates for follitropin beta

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 6/2010	Austria		PRODUCT NAME: CORIFOLLITROPIN ALFA
2010C/023	Belgium		PRODUCT NAME: CORIFOLLITROPIN ALFA; AUTHORISATION NUMBER AND DATE: EU/1/09/609/001 20100126
SZ 13/2001	Austria		PRODUCT NAME: LUTROPIN ALFA

Market Dynamics and Financial Trajectory for the Biologic Drug: Follitropin Beta

Last updated: July 29, 2025

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Introduction

Follitropin beta, a recombinant form of follicle-stimulating hormone (FSH), plays a pivotal role in assisted reproductive technologies (ART) such as in vitro fertilization (IVF). As a biologic agent, its market influences fertility treatment landscapes and pharmaceutical investment strategies. The current dynamics revolve around clinical efficacy, regulatory pathways, pricing strategies, and evolving patient needs. This analysis delineates the market ecosystem, competitive landscape, regulatory influences, and financial trajectory projections for follitropin beta, Illuminating future trends for stakeholders.

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Market Overview and Growth Drivers

Global Fertility Market Expansion

The fertility services market exhibits robust growth, projected to reach USD 34.2 billion by 2027, expanding at a CAGR of approximately 8% (Grand View Research). Factors fueling this include rising infertility prevalence—affected by delayed childbearing, lifestyle factors, and reproductive health issues—and increased acceptance of fertility treatments. Follitropin beta, integral to ovarian stimulation protocols, benefits from this expanding base.

Clinical Adoption and Efficacy

Follitropin beta’s favorable safety profile, high purity, and consistent dosing contribute to its widespread acceptance. Its recombinant technology ensures reduced immunogenicity relative to urinary-derived FSH. Leading clinicians favor follitropin beta for predictable follicular response, driving steady demand.

Regulatory Environment and Approvals

Major markets like the U.S., EU, and Japan have granted regulatory approvals for follitropin beta, often via accelerated pathways due to its validated safety. The approval of biosimilars has increased price competition but has also expanded access, thus influencing market dynamics and revenue streams.

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Competitive Landscape

Key Players

• Merck KGaA (EMD Serono): Market leader with PureFollitropin Beta, leveraging its established reputation.
• Ferring Pharmaceuticals: Offers Follitropin Alpha, directly competing but with overlapping indications.
• Crucell (Janssen), OrganoTherapeutics: Developing biosimilars to expand the market.

The entry of biosimilars, particularly in Europe and Asia, has challenged branded follitropin beta’s market share, prompting price reductions and intensified marketing efforts.

Pricing and Reimbursement Trends

Pricing strategies reflect local healthcare policies. In Europe, reimbursement pressures and biosimilar uptake have led to significant price erosion (up to 30%), impacting revenue margins. In developed markets, advanced insurance coverage mitigates some pressure, sustaining revenue flow.

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Regulatory and Patent Landscape

Patent Expiry and Biosimilar Competition

Patents protecting follitropin beta formulations are set to expire in select jurisdictions by 2025-2027, opening avenues for biosimilar manufacturers to penetrate markets. While biosimilars are not identical to the original biologic, regulatory pathways in regions like the EU facilitate market entry based on demonstrating biosimilarity.

Regulatory Challenges and Opportunities

Navigating complex biosimilar approval processes, including demonstrating analytical similarity and clinical efficacy, influences market entry timelines. Enhanced regulatory harmonization and advocacy for biosimilar acceptance are vital for foundational shifts in the market dynamics.

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Financial Trajectory Analysis

Revenue Generation

In 2022, the global follitropin beta market was valued around USD 1.2 billion, with Merck KGaA commanding approximately 60% of sales. The revenue is driven by the high demand within fertility clinics and hospitals, particularly in emerging markets where access policies are evolving.

Impact of Biosimilars

Projected biosimilar entries are anticipated to reduce revenue growth for original biologics by 15-20% over the next five years. Nonetheless, the total market size is expected to grow as access expands globally, offsetting some margin erosion.

Emerging Markets and Expansion

Investment in Asia-Pacific and Latin America offers significant financial upside. Fertility treatments are becoming more accessible, supported by local regulatory approvals and partnerships. The decreasing cost of biosimilars facilitates broader adoption, increasing overall market volume.

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Technological and Therapeutic Trends

Innovations in Recombinant Technology

Next-generation recombinant techniques aim to improve production yield, reduce costs, and enhance stability. Such innovations could influence price points and market competitiveness.

Personalized Medicine and Dosing Optimization

Increasing emphasis on individualized treatment protocols enhances efficiency, possibly leading to premium pricing models for tailored follitropin beta regimens—impacting profitability positively.

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Market Challenges and Risks

• Biosimilar Competition: While expanding access, biosimilars can suppress pricing power.
• Regulatory Barriers: Variability across jurisdictions can delay market entry.
• Market Saturation: In mature markets, growth is plateauing without innovation or geographical expansion.
• Reimbursement Policies: Cost-containment efforts might limit reimbursement levels, affecting margins.

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Future Outlook and Strategic Opportunities

The outlook for follitropin beta remains cautiously optimistic, contingent upon successful biosimilar proliferation and regional market expansion. Companies investing in biosimilar development, innovative formulations, or delivery systems that improve patient compliance could sustain or exceed current revenue levels. Strategic alliances, patent litigations, and regulatory advocacy are critical components shaping future financial trajectories.

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Key Takeaways

• The global fertility market is expanding due to demographic and societal changes, directly benefiting follitropin beta sales.
• Biosimilar competition will drive pricing adjustments but also widen market access.
• Regulatory differences affect market entry timelines, influencing revenue forecasts.
• The upcoming patent expirations create both challenges and opportunities for original manufacturers.
• Ongoing technological innovations and personalized treatment approaches can augment profitability and market share.

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FAQs

1. How will biosimilar entry influence follitropin beta’s market share?
Biosimilars are expected to erode price premiums and shift market share, especially in Europe and Asia, where biosimilar acceptance accelerates. However, they also expand overall market size by increasing access, which can offset some revenue declines for original products.

2. What regions present the greatest growth potential for follitropin beta?
Emerging markets in Asia-Pacific, Latin America, and parts of Africa show significant growth potential owing to increasing healthcare infrastructure, rising fertility awareness, and evolving reimbursement policies.

3. How do regulatory challenges impact forecasting?
Stringent biosimilar approval criteria and regional approval processes can delay market entries, affecting short-term revenue projections but potentially stabilizing long-term growth through expanding access.

4. What innovations could future-proof follitropin beta’s market position?
Advancements in recombinant technology, novel delivery systems, and personalized dosing strategies could distinguish products and command premium pricing, safeguarding margins against biosimilar competition.

5. What strategic moves should pharma companies consider?
Investing in biosimilar development, forging regional partnerships, engaging in regulatory advocacy, and focusing on innovative formulations form a comprehensive strategy to optimize financial outcomes amid evolving market dynamics.

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References

1. Grand View Research. Fertility Services Market Size, Share & Trends Analysis Report.
2. Merck KGaA Annual Report 2022.
3. European Medicines Agency (EMA). Biosimilar Guidelines.
4. World Health Organization. Reproductive health statistics (2021).
5. MarketWatch. Biologic Drugs Market Forecast 2023-2028.

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This comprehensive overview underscores the intricate interplay of technological, regulatory, and market factors shaping the future financial trajectory of follitropin beta.