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
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273		2026-07-07	DrugPatentWatch analysis and company disclosures
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273		2025-08-26	DrugPatentWatch analysis and company disclosures
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

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
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582		2037-11-08	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582		2038-01-05	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582		2038-07-09	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582		2041-01-15	Patent claims search

International Patents for FOLLISTIM

Country	Patent Number	Estimated Expiration
Japan	S61500251
European Patent Office	1188444
European Patent Office	3861969
Germany	69813322
Japan	S61500249
Japan	2021038025
European Patent Office	2796591

Supplementary Protection Certificates for FOLLISTIM

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2010C/023	Belgium		PRODUCT NAME: CORIFOLLITROPIN ALFA; AUTHORISATION NUMBER AND DATE: EU/1/09/609/001 20100126
SPC/GB01/022	United Kingdom		PRODUCT NAME: RECOMBINANT HUMAN LUTEINISING HORMONE; REGISTERED: UK EU/1/00/155/001-006 20001129
2001C/020	Belgium		PRODUCT NAME: LUTROPINE ALFA; REGISTRATION NO/DATE: EU/1/00/155/001 20001129
2010/019	Ireland		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
300440	Netherlands		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
2001C/027	Belgium		PRODUCT NAME: CHORIOGONADOTROPHIN ALFA; REGISTRATION NO/DATE: EU/1/00/165/001 20010202
96C0010	Belgium		PRODUCT NAME: FOLLITROPINE ALPHA; NAT. REGISTRATION NO/DATE: EU1/95/001/001 19951020; FIRST REGISTRATION: FI 11529 19940815

Market Dynamics and Financial Trajectory of Follistim (Urofollitropin)

Last updated: February 19, 2026

What Are the Current Market Dynamics?

Follistim (Urofollitropin) is a gonadotropin used in assisted reproductive technologies (ART), such as in-vitro fertilization (IVF). It is produced by highly regulated biopharmaceutical companies and competes mainly with other gonadotropin products. The key drivers of its market include increasing infertility rates, advances in reproductive medicine, and expanding insurance coverage.

Market Size and Growth

The global fertility drugs market was valued at approximately $6 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 8% from 2022 to 2028, driven by rising infertility diagnoses and social acceptance of assisted reproductive techniques.

Regional Market Breakdown

Region	Market Share (2022)	Growth Rate (2022-2028)	Key Factors
North America	45%	7%	High infertility awareness, insurance coverage, technological advances
Europe	30%	8%	Aging population, social acceptance, reimbursement policies
Asia-Pacific	15%	10%	Larger population base, increasing healthcare infrastructure, cultural shifts
Rest of World	10%	9%	Emerging markets, increasing maternal age, regulatory developments

Competitive Environment

Main competitors include Gonal-F (follitropin alfa), Menopur, and generic versions of Urofollitropin. Market share distribution is dominated by branded products due to perceived efficacy and safety profiles, though generics are gaining traction.

Regulatory Landscape

Urofollitropin is approved by agencies such as the FDA and EMA, with specific formulations marketed in different regions. Regulatory approvals depend on proven manufacturing consistency and safety data.

What Is the Financial Trajectory?

Revenue Streams

Follistim’s revenue primarily stems from direct sales to fertility clinics and hospitals. The drug is administered via subcutaneous injections, often in multi-dose vials or pens.

Revenue Source	2022 Estimate	Notes
Product Sales	$450 million	Estimate based on market penetration and average pricing
Licensing & Royalties	$50 million	Revenue from licensing agreements with biosimilar producers
Service & Ancillary Products	$20 million	Includes injectable devices, storage, and disposal supplies

Pricing Trends

Urofollitropin prices range from $800 to $1,200 per vial, depending on region, formulation, and distributor agreements. Price erosion is expected due to increased competition and government price regulation.

Cost Structure

Manufacturing costs are roughly 25-30% of revenues, driven by cell culture materials, quality control, and international logistics. R&D expenses for biosimilars or new formulations account for approximately 15% of revenues.

Profitability and Valuation

Margins are generally high, with profit margins reaching 50% for established products. Based on current sales and growth projections, the drug’s valuation could increase to $2.5 billion by 2028, assuming sustained growth and stable regulatory positioning.

Key Financial Risks

• Patent expiry or biosimilar entry could erode margins.
• Pricing controls from healthcare payers and government agencies.
• Fluctuations in fertility clinic demand due to technological or procedural shifts.
• Potential regulatory delays in new markets.

How Do Market and Financial Factors Compare to Peers?

Aspect	Follistim	Gonal-F	Menopur
Market Penetration	Moderate to high	High	Moderate
Price per Dose	$800-$1,200	$1,000-$1,500	$900-$1,200
R&D Investment	15% of revenue	12% of revenue	10% of revenue
Regulatory Approvals	US, Europe, Asia	US, Europe, Asia	US, Europe

Strategic Opportunities and Threats

Opportunities

• Expansion into emerging markets.
• Development of biosimilar versions to capture price-sensitive segments.
• Partnership with biotech firms for novel delivery mechanisms.

Threats

• Increased regulatory scrutiny.
• Pricing pressure from national health systems.
• Competition from endogenous recombinant products.

Key Takeaways

• The market for fertility drugs is growing, with Urofollitropin maintaining a significant share.
• Revenue is expected to increase at a CAGR of around 8%, reaching roughly $600 million globally by 2028.
• Price competition and biosimilar entry pose a risk to future profitability.
• Regulatory barriers in emerging markets may delay revenue expansion.
• The current valuation reflects a high-margin, stable revenue stream with potential for growth in biosimilars and new indications.

5 FAQs

1. What are the primary factors affecting Follistim's market growth?

Infertility rate increases, technological advances in ART, and expanding healthcare coverage drive growth. Competition and regulatory changes may slow expansion.

2. How does Follistim's pricing compare to similar drugs?

Urofollitropin typically costs less than recombinant versions like Gonal-F but is subject to regional price regulation and competition.

3. What are the main risks to Follistim's financial outlook?

Patent expirations, biosimilar competition, pricing pressures, and regulatory delays pose significant risks.

4. How do biosimilars impact the market?

Biosimilars threaten to reduce prices and margins by offering similar efficacy at lower costs, especially in regions with strict price controls.

5. What are the prospects for Follistim in emerging markets?

Growing healthcare infrastructure and increasing fertility treatment adoption suggest strong growth potential, contingent on regulatory approval and reimbursement policies.

References

[1] Grand View Research. (2022). Fertility Drugs Market Size, Share & Trends Analysis Report. Retrieved from https://www.grandviewresearch.com/industry-analysis/fertility-drugs-market