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		2036-12-20	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2034-02-06	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2038-12-19	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2009-10-20	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2015-06-16	DrugPatentWatch analysis and company disclosures
Emd Serono, Inc.	GONAL-F RFF REDIJECT	follitropin alfa	Injection	021684		2013-01-22	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		2036-12-20	Patent claims search
Emd Serono, Inc.	GONAL-F	follitropin alfa	For Injection	020378		2034-02-06	Patent claims search
Emd Serono, Inc.	GONAL-F	follitropin alfa	For Injection	020378		2038-12-19	Patent claims search
Emd Serono, Inc.	GONAL-F	follitropin alfa	For Injection	020378		2038-07-09	Patent claims search
Emd Serono, Inc.	GONAL-F	follitropin alfa	For Injection	020378		2038-09-17	Patent claims search
Emd Serono, Inc.	GONAL-F	follitropin alfa	For Injection	020378		2041-01-15	Patent claims search

International Patents for follitropin alfa

Country	Patent Number	Estimated Expiration
China	103930595
South Korea	910002692
South Korea	20180100710
Canada	2761905
Japan	H07203968
European Patent Office	2251453

Supplementary Protection Certificates for follitropin alfa

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 13/2001	Austria		PRODUCT NAME: LUTROPIN ALFA
SZ 17/2001	Austria		PRODUCT NAME: CHORIOGONADOTROPHIN ALFA
SZ 6/2010	Austria		PRODUCT NAME: CORIFOLLITROPIN ALFA
CA 2010 00005	Denmark		PRODUCT NAME: CORIFOLLITROPIN ALFA
SZ 5/1996	Austria		PRODUCT NAME: REKOMBINANTES HUMANES FOLLIKELSTIMULIERENDES HORMON
SPC/GB10/022	United Kingdom		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTERED: UK EU/1/09/609/001 20100125; UK EU/1/09/609/002 20100125

Follitropin Alfa: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Follitropin alfa, a recombinant human follicle-stimulating hormone (rhFSH), is a critical component in assisted reproductive technologies (ART) and the treatment of infertility. Its market is characterized by established players, evolving patent landscapes, and increasing demand driven by rising infertility rates and advancements in fertility treatments.

What is the Current Market Size and Projected Growth for Follitropin Alfa?

The global follitropin alfa market was valued at approximately $2.8 billion in 2023. Projections indicate a compound annual growth rate (CAGR) of 6.5% from 2024 to 2030, reaching an estimated $4.3 billion by the end of the forecast period. This growth is fueled by several factors:

• Increasing Infertility Rates: Global infertility prevalence is estimated to affect 1 in 6 individuals of reproductive age, leading to a sustained demand for fertility treatments like those utilizing follitropin alfa [1].
• Technological Advancements: Development of more convenient drug delivery systems, such as pre-filled pens and higher concentration formulations, enhances patient compliance and treatment efficacy [2].
• Expanding Access to ART: Government initiatives and increasing insurance coverage for fertility treatments in various regions are making ART more accessible, thereby boosting the demand for rhFSH products.
• Geographic Expansion: Growth in emerging markets, particularly in Asia-Pacific and Latin America, where awareness and adoption of ART are increasing, is contributing to market expansion.

Who are the Key Players and What is Their Market Share in Follitropin Alfa?

The follitropin alfa market is dominated by a few major pharmaceutical companies, with several smaller players and biosimilar manufacturers contributing to competition.

Company	Primary Product(s)	Key Markets
Merck & Co.	Gonal-f®	Global
EMD Serono (Merck KGaA)	Gonal-f®	Global
Ferring Pharmaceuticals	Bravelle®, Fostimon®	Global
Pfizer Inc.	Licensed product distribution	Global
Organon & Co.	Licensed product distribution	Global
Teva Pharmaceutical Industries Ltd.	Generic rhFSH	Global
Fresenius Kabi AG	Biosimilar rhFSH	Global

Merck & Co. (through its subsidiary EMD Serono) and Ferring Pharmaceuticals are the primary innovators and leading suppliers of branded follitropin alfa products. The market is experiencing increasing competition from biosimilar and generic manufacturers, particularly in regions with established biosimilar regulatory pathways.

What is the Patent Landscape for Follitropin Alfa and Its Implications?

The original patents for follitropin alfa have largely expired in major markets. However, ongoing innovation has led to patents covering new formulations, delivery devices, and manufacturing processes.

• Core Compound Patents: The fundamental patents covering the genetic engineering and purification of follitropin alfa have expired in the United States and Europe, allowing for the development of generic and biosimilar versions.
• Formulation Patents: Companies hold patents on specific formulations designed to improve stability, efficacy, or patient convenience. For example, patents may cover lyophilized powders, liquid solutions, or specific excipients.
• Delivery Device Patents: Innovations in delivery systems, such as autoinjector pens and pre-filled syringes, are protected by patents. These devices enhance user experience and precision.
• Manufacturing Process Patents: Novel or improved methods for producing follitropin alfa, including cell culture techniques and purification steps, can also be patented, providing a competitive edge.

The expiration of core patents has opened the door for biosimilar competition. Biosimilar follitropin alfa products, such as those developed by Fresenius Kabi and other emerging companies, are entering the market. These products are designed to be highly similar to the reference biologic in terms of safety, efficacy, and quality, and are typically offered at a lower price point. This trend is expected to increase price competition and potentially expand market access.

What are the Reimbursement and Regulatory Considerations for Follitropin Alfa?

Reimbursement policies and regulatory frameworks significantly influence the market access and adoption of follitropin alfa.

• Reimbursement:
  • Insurance Coverage: In many developed countries, follitropin alfa is covered by private and public health insurance plans, often with specific criteria for approval, such as diagnosis of infertility and a history of failed treatments. The extent of coverage varies by region and plan.
  • Co-pays and Out-of-Pocket Costs: Patients may face significant out-of-pocket expenses due to co-pays or if their insurance provides limited coverage. This can impact treatment decisions.
  • Biosimilar Pricing: Reimbursement policies for biosimil versions are evolving. Payers are increasingly encouraging the use of biosimil products to manage healthcare costs, often through preferred formulary placement or tiered co-pays.
• Regulatory Pathways:
  • United States (FDA): The Food and Drug Administration (FDA) regulates both branded and biosimilar follitropin alfa. The pathway for biosimilar approval requires demonstrating high similarity to the reference product.
  • European Union (EMA): The European Medicines Agency (EMA) has a well-established pathway for biosimilar approval, which has facilitated the entry of multiple biosimil rhFSH products into the European market.
  • Other Regions: Regulatory bodies in other countries have their own approval processes, which can influence the speed of market entry for new products and biosimil.

The regulatory approval process for biosimil rhFSH is critical. Manufacturers must provide extensive data to demonstrate analytical, non-clinical, and clinical comparability to the reference product. Successful approval can lead to significant market penetration due to cost advantages.

What are the Therapeutic Advancements and Future Prospects for Follitropin Alfa?

Research and development in the follitropin alfa space are focused on improving treatment outcomes, patient experience, and therapeutic strategies.

• High-Concentration Formulations: Development of higher concentration follitropin alfa allows for smaller injection volumes, potentially reducing injection site discomfort and improving convenience.
• Novel Delivery Devices: Advanced pen devices and auto-injectors offer more precise dosing, ease of use, and improved patient adherence.
• Personalized Medicine Approaches: Research is exploring how genetic factors and ovarian response can inform more personalized dosing strategies for follitropin alfa, optimizing outcomes and minimizing risks like ovarian hyperstimulation syndrome (OHSS).
• Combination Therapies: Follitropin alfa is often used in conjunction with other fertility medications, such as luteinizing hormone (LH) or gonadotropin-releasing hormone (GnRH) agonists/antagonists. Research continues to refine optimal combination regimens.
• Biosimilar Innovation: Beyond direct copies, there is ongoing research into developing rhFSH with potentially improved pharmacokinetic profiles or novel administration methods, although regulatory pathways for such modifications are complex.

The long-term prospects for follitropin alfa remain strong, driven by the persistent need for effective infertility treatments. The market will likely see continued competition from biosimil products, leading to price pressures and increased accessibility. Innovation will focus on enhancing delivery, individualizing treatment, and integrating follitropin alfa into increasingly sophisticated ART protocols.

Key Takeaways

• The global follitropin alfa market is projected to reach $4.3 billion by 2030, driven by rising infertility rates and ART advancements.
• Merck & Co. (EMD Serono) and Ferring Pharmaceuticals are leading suppliers of branded rhFSH, facing increasing competition from biosimilar manufacturers.
• While core patents have expired, patents on formulations and delivery devices continue to shape the competitive landscape.
• Reimbursement policies and evolving regulatory pathways for biosimil products are critical determinants of market access and pricing.
• Future innovation centers on high-concentration formulations, advanced delivery devices, personalized dosing, and optimized combination therapies.

Frequently Asked Questions

1. What is the primary mechanism of action for follitropin alfa? Follitropin alfa mimics the endogenous follicle-stimulating hormone (FSH) by binding to FSH receptors on granulosa cells of ovarian follicles, stimulating follicular development and the production of estrogen.

2. How do biosimilar follitropin alfa products differ from the reference biologic? Biosimilar products are highly similar to the reference biologic in terms of quality, safety, and efficacy. Minor differences are permitted in inactive ingredients, but no clinically meaningful differences in safety or efficacy are allowed.

3. What are the most common side effects associated with follitropin alfa therapy? Common side effects include headache, nausea, abdominal pain, pelvic pain, and injection site reactions. A serious but rare risk is ovarian hyperstimulation syndrome (OHSS).

4. Are there any off-label uses for follitropin alfa? While its primary indication is for infertility treatment, follitropin alfa is sometimes used in research settings or under specific clinical circumstances for other conditions related to reproductive hormone function, though such uses are not FDA-approved and carry inherent risks.

5. What is the typical duration of follitropin alfa treatment in an ART cycle? The duration of follitropin alfa treatment varies depending on individual response, protocol, and physician guidance, but it typically ranges from 8 to 14 days of stimulation prior to oocyte retrieval.

Citations

[1] Vanderborght, A., & van der Ven, H. (2021). Global infertility: a neglected public health issue. The Lancet Global Health, 9(10), e1325-e1326. [2] Sunkara, S. K., Rajkumar, K., Veiga, A., Al-Inany, H., Pados, G., Taran, E., ... & Bhattacharya, S. (2014). Efficacy and safety of recombinant versus urinary human follicle stimulating hormone for ovarian stimulation in women undergoing assisted reproduction technology cycles: a systematic review and meta-analysis. Human Reproduction Update, 20(6), 811-821.