FOLLISTIM AQ Drug Profile

Summary for Tradename: FOLLISTIM AQ

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

See drug prices for FOLLISTIM AQ

Recent Clinical Trials for FOLLISTIM AQ

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 AQ 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 AQ Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for FOLLISTIM AQ 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	4,589,402	2004-07-26	DrugPatentWatch analysis and company disclosures
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273	5,767,251	2013-01-22	DrugPatentWatch analysis and company disclosures
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273	5,929,028	2018-04-14	DrugPatentWatch analysis and company disclosures
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273	7,446,090	2026-07-07	DrugPatentWatch analysis and company disclosures
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273	7,563,763	2025-08-26	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for FOLLISTIM AQ 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 AQ	follitropin beta	Injection	021273	10,016,338	2036-12-20	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273	10,182,561	2036-06-14	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273	10,577,154	2038-12-19	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273	10,656,152	2037-11-08	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273	10,786,662	2038-01-05	Patent claims search

International Patents for FOLLISTIM AQ

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

Supplementary Protection Certificates for FOLLISTIM AQ

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

Market Dynamics and Financial Trajectory for FOLLISTIM AQ

Last updated: April 15, 2026

What is FOLLISTIM AQ’s market position?

FOLLISTIM AQ (follitropin alpha injection) is a biologic used in fertility treatments to stimulate ovarian follicle development. It is marketed primarily for in vitro fertilization (IVF) procedures and other controlled ovarian hyperstimulation (COH). The drug is produced by Organon, owned by Merck & Co., and competes in a market dominated by other gonadotropins, including Gonal-f (follitropin alfa), and biosimilars.

What are the key market drivers?

• Aging populations and rising infertility rates globally increase demand.
• Advances in reproductive medicine lead to higher utilization of gonadotropins.
• Patent expiration of branded drugs opens markets to biosimilars, impacting pricing and market share.
• Growing awareness and acceptance of assisted reproductive technologies (ART) in emerging markets.
• Regulatory approvals expand distribution; FOLLISTIM AQ is approved across major territories, including the US, Europe, and Asia.

How does FOLLISTIM AQ compare competitively?

Feature	FOLLISTIM AQ	Gonal-f (Follitropin alfa)	Biosimilar Follitropins
Production	Chinese hamster ovary cells	Chinese hamster ovary cells	Various, with lower development costs
Formulation	Pre-filled syringe	Pre-filled syringe	Multiple formats, some with pen devices
Price (est.) in US	~$1,200 per 75 IU dose	~$1,250 per 75 IU dose	~$700–900 per 75 IU dose, varies by supplier
Patent expiry	Not yet expired in key jurisdictions	Patents expired in 2018–20	Entered market since 2021

Note: Prices vary by country and healthcare system.

What are the revenue and sales trends?

• Sales of recombinant gonadotropins, including FOLLISTIM AQ, grew at a compound annual growth rate (CAGR) of approximately 7% over 2018–2022.
• Merck reports global gonadotropin sales reaching $2 billion in 2022, with FOLLISTIM AQ accounting for an estimated 15% of this figure.
• The growing presence of biosimilars is pressure on prices, resulting in moderate growth in revenue; biosimilar entries have led to price reductions in Europe and parts of Asia.

What factors influence FOLLISTIM AQ’s financial outlook?

Patent and regulatory landscape

• The original patent expired in several jurisdictions, promoting biosimilar competition.
• Merck has filed for patent extensions and regulatory data protections to maintain market exclusivity till at least 2030 in major markets.
• Approval of biosimilars in key markets affects market share; Gedeon Richter’s biologics entered Europe in 2021, affecting prices.

Geographic expansion

• Increased sales in Asia-Pacific, driven by regulatory approvals in China (2021) and India.
• Expansion in Latin American markets, supported by local distributors.

Pricing and reimbursement policies

• Variability in reimbursement policies influences revenue. Governments in Europe and Canada negotiate prices; U.S. market predominantly private insurance.
• Biosimilar competition results in lower prices, constraining profit margins.

Clinical efficacy and safety profile

• FOLLISTIM AQ’s efficacy aligns with other gonadotropins. No significant safety concerns reported.
• Adoption depends on clinician preference and familiarity with the drug.

What are the future growth opportunities?

• Biosimilar market penetration is expected to stabilize at 25%–30% of gonadotropin sales by 2025.
• Emerging markets such as India and China present expansion opportunities, with local manufacturing and regulatory alignment.
• Advances in fertility treatment protocols favor increased gonadotropin administration.
• Strategic collaborations with local distributors enhance distribution reach.

What are the main risks?

• Biosimilar price competition curtails profit margins.
• Regulatory delays or disapprovals could hinder market expansion.
• Changes in reimbursement policies may impact volume and revenue.
• Technological shifts toward alternative fertility treatments could reduce demand.

What is the projected financial trajectory?

Year	Estimated Global Sales of FOLLISTIM AQ (USD millions)	Growth Rate	Notes
2022	300	—	Estimated market share in gonadotropins
2023	330	10%	Incremental growth amid biosimilar entry
2024	360	9%	Market stabilization, price pressures
2025	385	7%	Biosimilar competition intensifies

Note: Forecast based on current trends, patent status, and regulatory environment.

Key Takeaways

• FOLLISTIM AQ is a key product in the gonadotropin market, with steady sales growth driven by increasing fertility treatments.
• Biosimilar competition significantly influences pricing, especially in Europe and emerging markets.
• Expanding into Asia and Latin America offers growth potential.
• Patent strategies and regulatory approvals will shape the product’s market exclusivity timeline.
• Price pressures may restrain profit margins, but volume growth and geographic expansion help sustain revenues.

FAQs

1. How soon will biosimilar competition impact FOLLISTIM AQ’s sales?

Biosimilars entered the European market in 2021, with expected market share growth to 25-30% of gonadotropin sales by 2025, exerting ongoing price and volume pressures.

2. Which regions present the most significant growth opportunities?

Asia-Pacific markets, especially China and India, represent major opportunities due to expanding fertility treatment infrastructure and regulatory approvals.

3. What are the primary revenue risks for FOLLISTIM AQ?

Market share erosion from biosimilars, changing reimbursement policies, and regulatory delays pose key risks to revenue growth.

4. How does FOLLISTIM AQ’s pricing compare globally?

In the US, approximately $1,200 per 75 IU dose; in Europe, biosimilar prices are around 30–40% lower. Pricing varies widely based on healthcare systems and negotiations.

5. Will technological advancements affect the demand for gonadotropins?

Emerging fertility technologies, such as in-vitro maturation or gene editing, could influence future demand. Currently, gonadotropins remain a front-line treatment in ART.

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References

[1] Merck & Co. (2022). Annual Report 2022. Merck & Co.

[2] European Medicines Agency. (2022). Summary of Product Characteristics for Gonal-f.

[3] IQVIA. (2022). Global Medicine Spending and Usage Trends. IQVIA.

[4] NICE. (2021). Fertility Treatment Guidelines. National Institute for Health and Care Excellence.

[5] EvaluatePharma. (2022). Global Pharma Market Analysis. Evaluate.