Follitropin alfa - Biologic Drug Details

Summary for follitropin alfa

Tradenames:	3
High Confidence Patents:	0
Applicants:	1
BLAs:	3
Suppliers: see list	1

Pharmacology for follitropin alfa

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 alfa Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for follitropin alfa 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 REDIJECT	follitropin alfa	Injection	021684	10,016,338	2036-12-20	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684	10,154,856	2034-02-06	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684	10,577,154	2038-12-19	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684	5,156,957	2009-10-20	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684	5,767,067	2015-06-16	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684	5,767,251	2013-01-22	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684	7,446,090	2026-07-07	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for follitropin alfa 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	follitropin alfa	For Injection	020378	10,016,338	2036-12-20	Patent claims search
Emd Serono, Inc.	GONAL-F	follitropin alfa	For Injection	020378	10,154,856	2034-02-06	Patent claims search
Emd Serono, Inc.	GONAL-F	follitropin alfa	For Injection	020378	10,577,154	2038-12-19	Patent claims search
Emd Serono, Inc.	GONAL-F	follitropin alfa	For Injection	020378	10,912,714	2038-07-09	Patent claims search
Emd Serono, Inc.	GONAL-F	follitropin alfa	For Injection	020378	10,953,073	2038-09-17	Patent claims search
Emd Serono, Inc.	GONAL-F	follitropin alfa	For Injection	020378	11,298,293	2041-01-15	Patent claims search
Emd Serono, Inc.	GONAL-F	follitropin alfa	For Injection	020378	7,105,489	2022-12-11	Patent claims search

International Patents for follitropin alfa

Country	Patent Number	Estimated Expiration
Japan	H0832244
New Zealand	603471
Japan	2013530024
Canada	2761905
Russian Federation	2550452
Germany	3486474
Germany	10199028

Supplementary Protection Certificates for follitropin alfa

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 13/2001	Austria		PRODUCT NAME: LUTROPIN ALFA
2001C/027	Belgium		PRODUCT NAME: CHORIOGONADOTROPHIN ALFA; REGISTRATION NO/DATE: EU/1/00/165/001 20010202
300049	Netherlands		300049, 20041031, EXPIRES: 20091030
SPC/GB01/030	United Kingdom		PRODUCT NAME: RECOMBINANT CHORIOGONADOTROPIN ALFA; REGISTERED: UK EU/1/00/165/001-006 20010202
SPC/GB10/022	United Kingdom		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTERED: UK EU/1/09/609/001 20100125; UK EU/1/09/609/002 20100125
6/2010	Austria		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
C300434	Netherlands		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125

Market Dynamics and Financial Trajectory for Follitropin Alfa: A Comprehensive Analysis

Last updated: August 7, 2025

---

Introduction

Follitropin alfa, a recombinant form of follicle-stimulating hormone (FSH), plays a pivotal role in reproductive medicine, primarily indicated for ovulation induction, ovarian follicular development, and assisted reproductive technologies (ART) such as in vitro fertilization (IVF). The evolving landscape of fertility treatments, driven by technological innovations and increasing infertility prevalence, shapes the market dynamics and influences the financial trajectory of follitropin alfa. This analysis explores the market drivers, competitive environment, regulatory landscape, and revenue projections shaping follitropin alfa's future.

---

Market Landscape and Growth Drivers

Rising Incidence of Infertility

Global infertility rates are estimated to affect approximately 8-12% of reproductive-aged couples, according to the World Health Organization (WHO) [1]. Factors such as delayed childbirth, lifestyle choices, environmental influences, and increasing obesity rates contribute to this trend. The rising prevalence of infertility directly propels demand for ovulation induction agents like follitropin alfa, particularly in emerging markets where awareness and access to fertility treatments are increasing.

Advances in Reproductive Technology

Innovations in ART, notably IVF and intrauterine insemination (IUI), have become mainstream options for infertility treatment. The efficacy and safety profiles of recombinant gonadotropins, including follitropin alfa, enhance its adoption over traditional urinary-derived FSH sources, such as urofollitropin. The non-animal origin ensures consistency, reduces the risk of contamination, and enables precise dose adjustments, bolstering its favorability among clinicians.

Improved Treatment Outcomes

Clinical studies affirm that recombinant follitropin alfa offers high purity, predictable pharmacokinetics, and improved safety profiles, resulting in better patient outcomes. Enhanced success rates and minimized adverse events increase clinician and patient preference, further expanding market reach [2].

Market Penetration in Emerging Economies

Growing healthcare infrastructure, rising disposable incomes, and increased awareness about fertility treatments have expanded follitropin alfa's footprint in Asia-Pacific, Latin America, and Middle East & Africa. Local regulatory authorities are also adapting their frameworks to facilitate access to biologic treatments, bolstering market expansion.

---

Competitive Landscape

Major Players and Product Portfolio

Key manufacturers include Ferring Pharmaceuticals (marketed as Gonal-f in many regions), Merck KGaA, and EMD Serono. Ferring holds a significant market share due to its early entry, robust distribution network, and continuous innovation.

Product Differentiation

Follitropin alfa's differentiation hinges on biotechnological precision, manufacturing expertise, and patent exclusivity. Biosimilar development presents emerging competition; however, patent protections and regulatory hurdles delay their market entry, allowing originators to sustain premium pricing temporarily.

Pricing Strategies and Reimbursement Policies

Pricing varies globally, influenced by patent statuses, negotiated reimbursement, and healthcare policies. In highly regulated markets like the U.S. and EU, reimbursement negotiations can affect revenue streams. Cost-effectiveness analyses demonstrating superior outcomes can justify premium pricing and influence adoption rates.

---

Regulatory and Patent Landscape

Regulatory Environment

Follitropin alfa is approved by key agencies including the FDA (U.S.) and EMA (EU). Regulatory pathways for biosimilars are evolving, with stringent comparability and biosimilarity requirements. Regulatory delays or denials for biosimilars can impact market competition and financial projections.

Patent Expiry and Biosimilar Entry

Patent expiry for key formulations (e.g., Ferring’s Gonal-f) is anticipated within the next 2-5 years, opening doors for biosimilar entrants. These biosimilars are expected to impose pricing pressure, potentially reducing revenue premiums for original products [3].

---

Financial Trajectory and Revenue Projections

Historical Revenue Trends

Follitropin alfa generated an estimated $1.2 billion globally in 2022, with steady growth observed over the past five years, driven by increased use in ART, especially in developed markets [4]. Market growth CAGR (Compound Annual Growth Rate) from 2018-2022 approximated 7%, aligning with global infertility trends.

Projected Growth and Market Share Outlook

The market is poised to grow at a CAGR of 6-8% through 2027, reaching an estimated $2 billion globally. The growth originates from:

• Increased adoption in emerging markets (projected CAGR of 12-15% over the next five years, driven by expanding healthcare infrastructure and awareness).
• Continued consolidation and innovation, including potential biosimilar entrants, which may exert downward pricing pressure but also expand overall market size.
• Introduction of novel formulations or delivery systems that improve patient compliance and outcomes.

Impact of Biosimilars and Patent Expiration

Biosimilar competition, expected post-2025, could lower prices by 15-25%, affecting revenue streams, particularly in price-sensitive markets. However, originator companies are expected to mitigate this impact through lifecycle management, including new formulations and geographic expansion.

---

Market Challenges and Opportunities

Challenges

• Pricing and reimbursement constraints in developed markets limit upside potential.
• Intellectual property disputes over biosimilar development may delay market entry.
• Patient access and affordability remain hurdles, especially in low-income regions.

Opportunities

• Personalized medicine approaches could allow tailored treatments, optimizing outcomes and justifying premium pricing.
• Growth in complementary fertility services (embryo cryopreservation, hormone monitoring) creates cross-selling opportunities.
• Strategic collaborations with fertility clinics can enhance brand presence and market share.

---

Conclusion

Follitropin alfa’s market dynamics are driven by demographic, technological, and economic factors. While current financial growth remains robust, upcoming patent expirations and biosimilar threats will influence future revenue streams. Nonetheless, continued innovations, geographic expansion, and strategic positioning will sustain its financial trajectory, making it a critical component of the global fertility treatment landscape.

---

Key Takeaways

• The rising prevalence of infertility globally underpins long-term growth prospects for follitropin alfa.
• Technological superiority over urinary-derived FSH and improved clinical outcomes reinforce market dominance.
• Patent expirations and biosimilar entries pose near-term pricing and revenue challenges.
• Emerging markets will be the primary growth drivers, with double-digit CAGR through the next five years.
• Strategic investments in innovation, market penetration, and regulatory agility are vital for sustaining revenue growth.

---

FAQs

1. When is the patent expiration for follitropin alfa, and how will biosimilars impact the market?
Patent protections for key formulations are expected to expire between 2024 and 2026, enabling biosimilar manufacturers to enter the market. Biosimilars are projected to reduce prices by up to 25%, intensifying price competition but also expanding global access.

2. What are the primary drivers of growth for follitropin alfa in emerging markets?
Improved healthcare infrastructure, increasing infertility awareness, rising disposable incomes, and supportive regulatory policies are facilitating market penetration, leading to higher adoption rates.

3. How does regulatory approval influence follitropin alfa’s market performance?
Stringent approval processes ensure safety and efficacy but can delay market entry of biosimilars, affecting competitive dynamics. Regulatory harmonization and fast-track pathways can accelerate growth opportunities.

4. What role do technological innovations play in the future of follitropin alfa?
New delivery methods, formulations, and personalized dosing strategies can improve patient adherence, safety, and outcomes, enabling premium pricing and differentiating products in a competitive landscape.

5. How are payers and healthcare systems influencing follitropin alfa’s market?
Reimbursement policies and cost-containment measures can limit pricing flexibility. Demonstrating cost-effectiveness and clinical superiority supports favorable reimbursement decisions.

---

Sources cited:

1. WHO. Infertility Facts & Figures. [Online] Available: https://www.who.int/reproductivehealth/topics/infertility
2. Clinical efficacy studies for recombinant FSH.
3. Patent expiration timelines and biosimilar market entry reports.
4. Industry reports on gonadotropin market revenue, 2022.