FOLLISTIM Drug Profile

Summary for Tradename: FOLLISTIM

High Confidence Patents:	9
Applicants:	2
BLAs:	3
Drug Prices:	Drug price information for FOLLISTIM
Recent Clinical Trials:	See clinical trials for FOLLISTIM

See drug prices for FOLLISTIM

Recent Clinical Trials for FOLLISTIM

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Ferring Pharmaceuticals	Phase 2
Center for Human Reproduction	Phase 1/Phase 2
Michigan Reproductive Medicine	Phase 4

See all FOLLISTIM clinical trials

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 FOLLISTIM Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for FOLLISTIM 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 Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273		2004-07-26	DrugPatentWatch analysis and company disclosures
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273		2013-01-22	DrugPatentWatch analysis and company disclosures
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273		2018-04-14	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for FOLLISTIM 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 FOLLISTIM

Country	Patent Number	Estimated Expiration
China	1309567
Australia	2011252925
New Zealand	603471

Supplementary Protection Certificates for FOLLISTIM

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SPC019/2010	Ireland		SPC019/2010: 20101001, EXPIRES: 20230112
96C0010	Belgium		PRODUCT NAME: FOLLITROPINE ALPHA; NAT. REGISTRATION NO/DATE: EU1/95/001/001 19951020; FIRST REGISTRATION: FI 11529 19940815
91655	Luxembourg		PRODUCT NAME: CORIFOLLITROPINE ALFA ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (ELONVA ); AUTHORISATION NUMBER AND DATE: EU/1/09/609/001-002 - ELONVA-CORIFOLLITROPINE ALFA; 20100125

Market Dynamics and Financial Trajectory for the Biologic Drug: Follistim

Last updated: September 26, 2025

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Introduction

Follistim, a prominent reproductive biologic drug with the active ingredient urofollitropin, has cemented its position in fertility treatments globally. As a recombinant form of follicle-stimulating hormone (FSH), Follistim plays a pivotal role in controlled ovarian hyperstimulation (COH), which is central to assisted reproductive technologies (ART). This analysis evaluates the current market landscape, competitive forces, regulatory environment, and financial prospects shaping Follistim’s trajectory over the coming years.

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Market Overview and Segmentation

The global fertility treatment market continues to expand, driven by increasing infertility rates, technological advancements, and supportive regulatory policies. The segment for gonadotropins like Follistim is expected to witness sustained growth owing to the rising preference for assisted reproductive procedures such as in vitro fertilization (IVF) and intrauterine insemination (IUI).

Key Market Drivers

• Rising Infertility Incidences: According to the World Health Organization (WHO), over 48 million couples suffer from infertility globally, fueling demand for ART solutions [1].
• Advancements in Reproductive Technologies: Enhanced efficiency and safety profiles of biologics like Follistim have increased adoption rates.
• Aging Demographics: Increased maternal age correlates with higher fertility issues, necessitating effective ovulation stimulation agents.
• Regulatory Support and Reimbursements: Favorable reimbursement policies, especially in developed markets, have bolstered ART utilization.

Market Segmentation

• By Geography: North America remains the largest market, followed by Europe and Asia-Pacific, with Asia-Pacific displaying rapid growth potential due to expanding healthcare infrastructure and increasing awareness.
• By Application: The primary application remains IVF procedures, with a smaller but growing niche in ovulation induction for ovulatory disorders.

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Competitive Landscape

Follistim operates in a competitive environment characterized by patent expirations, the emergence of biosimilars, and evolving treatment paradigms.

Major Players

• Ferring Pharmaceuticals: The originator brand Follistim, marketed in various regions.
• Merck KGaA: Offers similar formulations competing in the biosimilar space.
• Biosimilar Manufacturers: Increasingly, biosimilars from Indian and Chinese companies threaten established brands, pressuring prices and profit margins.

Market Dynamics

• Patent Expirations: The original patents for Follistim began expiring around 2018, opening doors for biosimilar development [2].
• Price Competition: Entry of biosimilars has led to significant price reductions, especially in emerging markets.
• Innovation and Formulation Improvements: Companies invest in formulations that enhance administration convenience and reduce side effects to gain market share.

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Regulatory Environment

Regulatory agencies such as the FDA and EMA have adopted rigorous standards for biologics, including biosimilars, to ensure safety, efficacy, and interchangeability.

• Biosimilar Approval Pathways: Given the expiration of patents, biositer formulations approved under robust pathways are poised to challenge Follistim’s market dominance.
• Reimbursement Policies: Variable across regions, with Western markets generally offering better coverage, thereby maintaining sales strength.

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Financial Trajectory and Revenue Forecast

Follistim’s financial prospects are heavily influenced by patent life, biosimilar competition, and evolving treatment preferences.

Historical Revenue Trends

Before patent expiry, Follistim reported robust revenues, averaging $400-600 million annually globally [3]. Post-expiry, revenues have declined in some regions due to biosimilar entry but remain significant owing to established brand loyalty and expanded indications.

Forecast for the Next 5-10 Years

• Short-term (1-3 years): Revenues may stabilize as biosimilars penetrate markets, leading to moderate declines of 10-20%. Strategic marketing and formulation improvements can mitigate losses.
• Mid-term (3-7 years): Investment in biosimilar development and adjunct indications could sustain revenue streams. Market expansion into emerging economies will provide new growth avenues.
• Long-term (7+ years): Market saturation by biosimilars might lead to reduced prices. However, ongoing innovation, such as longer-acting formulations or combination therapies, can regenerate market interest.

Influence of Industry Trends

• Biosimilar Competition: Pricing pressure will be intense, potentially leading to a commoditization of Follistim-like products unless brand differentiation persists through clinical advantages.
• Emergence of Novel Biologics: Advancements in targeted therapies or non-invasive procedures could alter the fertility treatment landscape, impacting demand.

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Strategic Implications

Pharmaceutical companies leveraging Follistim should prioritize:

• Investment in Biosimilar Development: To maintain market share amidst patent cliffs.
• Enhancing Product Accessibility: Through regional partnerships and regulatory navigation.
• Innovating on Formulation and Delivery: To improve patient compliance and outcomes.
• Expanding Indications: Beyond fertility, potentially in other hormonal deficiencies.

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Key Market Risks

• Regulatory Delays: Lengthy approval processes for biosimilars or new formulations.
• Pricing Pressures: Post-patent competition driving down revenues.
• Market Saturation: Limited growth opportunities in mature regions.
• Emerging Technologies: The advent of alternative fertility solutions may reduce reliance on gonadotropins.

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Conclusion

Follistim’s market ecosystem is shifting from a primarily branded to a competitive biosimilar landscape, imposing pressures on revenues but also presenting opportunities for adaptation. Its long-term financial trajectory hinges on innovation, strategic expansion into emerging markets, and navigating regulatory pathways effectively. Despite challenges, Follistim retains a core role within fertility therapeutics, especially when integrated with adjunct technologies and therapies.

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Key Takeaways

• The global fertility market's growth underpins Follistim’s ongoing relevance, particularly in IVF and ovulation induction.
• Patent expirations and biosimilar proliferation introduce significant pricing pressures, demanding strategic responses.
• Investment in formulation innovation and regional expansion can sustain revenues amid industry shifts.
• The future of Follistim hinges on balancing biosimilar competition with continued innovation and market diversification.
• Regulatory landscapes and reimbursement policies remain critical determinants of financial performance.

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FAQs

1. How does biosimilar entry affect Follistim’s profitability?
Biosimilar entry typically leads to price reductions and revenue erosion for the originator brand, compelling companies to innovate and differentiate to preserve profit margins.

2. What strategies can Follistim manufacturers adopt to sustain market share?
They should focus on developing longer-acting formulations, expanding indications, entering emerging markets, and forming strategic partnerships to enhance accessibility.

3. Are there emerging alternatives to gonadotropins like Follistim?
Yes, novel biologics, gene therapies, and non-invasive fertility technologies are under investigation, which could impact demand for traditional gonadotropins.

4. How significant is regional variation in Follistim’s market performance?
Very; North America and Europe constitute the largest markets, but growth potential is substantial in Asia-Pacific and Latin America, where fertility treatments are gaining traction.

5. What regulatory hurdles could threaten Follistim’s future?
Delays in biosimilar approvals, reimbursement restrictions, and changing safety standards can impact market access and profitability.

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References

[1] World Health Organization. (2021). Infertility definitions and statistics.
[2] Patent Expiration Data. (2018–2022). Industry Patent Filings and Expirations.
[3] Company Financial Reports. (Pre- and Post-Patent Expiry Revenue Figures).