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		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

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		2036-12-20	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273		2036-06-14	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273		2038-12-19	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273		2037-11-08	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273		2038-01-05	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM AQ	follitropin beta	Injection	021273		2038-07-09	Patent claims search

International Patents for FOLLISTIM AQ

Country	Patent Number	Estimated Expiration
Portugal	853945
China	110074968
Argentina	082615
Canada	2803613
China	103328026
Russian Federation	2550452

Supplementary Protection Certificates for FOLLISTIM AQ

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 6/2010	Austria		PRODUCT NAME: CORIFOLLITROPIN ALFA
2010C/023	Belgium		PRODUCT NAME: CORIFOLLITROPIN ALFA; AUTHORISATION NUMBER AND DATE: EU/1/09/609/001 20100126
SZ 13/2001	Austria		PRODUCT NAME: LUTROPIN ALFA
2010/019	Ireland		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
C300440	Netherlands		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125; FORMER OWNER: N.V. ORGANON, NL
SPC/GB01/030	United Kingdom		PRODUCT NAME: RECOMBINANT CHORIOGONADOTROPIN ALFA; REGISTERED: UK EU/1/00/165/001-006 20010202

Market Dynamics and Financial Trajectory for the Biologic Drug: FOLLISTIM AQ

Last updated: September 26, 2025

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Introduction

FOLLISTIM AQ, known generically as follitropin alfa, is a recombinant human follicle-stimulating hormone (FSH) used primarily in reproductive medicine. As a biologic drug, it occupies a pivotal position in infertility treatments, including assisted reproductive technologies (ART) like in vitro fertilization (IVF). The landscape surrounding FOLLISTIM AQ is shaped by evolving market dynamics, regulatory environments, technological advancements, and competitive forces. Understanding these factors is crucial for stakeholders to anticipate financial trajectories and strategic opportunities within this sector.

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Market Overview

The global fertility treatment market, projected to reach USD 27 billion by 2030 (CAGR of approximately 10% from 2022-2030), underpins the demand for biologics like FOLLISTIM AQ. The rising prevalence of infertility, delayed childbearing age, and technological progress in reproductive medicine fuel this growth. FOLLISTIM AQ is a key player within this segment, owing to its proven efficacy, safety profile, and extensive clinical validation.

The demand for FOLLISTIM AQ is concentrated primarily within developed regions—North America and Europe—where infertility treatment access is widespread and insurance coverage promotes utilization. Emerging markets in Asia-Pacific and Latin America are witnessing rapid growth due to increasing awareness, improving healthcare infrastructure, and expanding insurance coverage.

The drug's position hinges on its differentiation as a recombinant, highly purified FSH, which reduces immunogenicity and enhances consistency over urinary-derived alternatives. Such advantages underpin its ongoing adoption and market penetration.

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Market Dynamics

Regulatory Landscape

Regulatory approval frameworks significantly influence FOLLISTIM AQ’s market expansion. The drug holds approvals from agencies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency), facilitating authorized use across key markets. However, regulatory bottlenecks, especially in emerging markets, restrict swift access, impacting sales trajectories.

Regulatory shifts also affect biosimilar entry, intensifying pricing pressures. The advent of biosimilars—such as biosimilar follitropins—introduces competitive challenges but also expands access due to lower prices, potentially eroding FOLLISTIM AQ's market share over time.

Competitive Landscape

FOLLISTIM AQ faces competition from several recombinant FSH products like GONAL-f (Merck), Puregon (Merck), and biosimilars entering markets, shifting the competitive dynamics. Companies are innovating, introducing dual hormone products, and developing personalized treatment regimens, which may influence demand patterns.

The competitive pressure also directs innovation toward genetically engineered, highly purified biologics capable of improving efficacy and safety. Furthermore, the rise of oral or alternative fertility treatments may impact future demand.

Technological Innovation

Advancements in bioprocessing, improved manufacturing techniques, and genomic medicine are transforming biologic drug development. For FOLLISTIM AQ, innovations include enhanced recombinant DNA technology to increase yield, reduce production costs, and improve product consistency.

Personalized medicine approaches—where treatments are tailored based on genetic markers—may also influence prescribing practices, favoring drugs with predictable pharmacodynamics like FOLLISTIM AQ.

Pricing and Reimbursement Dynamics

Pricing strategies for FOLLISTIM AQ are subject to regional policies. In markets with stringent healthcare budgets, such as Europe, reimbursement negotiations influence drug accessibility and sales volumes. Biosimilars’ entry often leads to substantial price reductions, pressuring originator brands to innovate or adjust pricing strategies.

In the United States, insurance coverage varies but generally favors established biologics due to clinical familiarity, supporting stable revenues. However, the increasing prevalence of biosimilars could lead to sustained downward pressure unless differentiation or improved outcomes justify premium pricing.

Market Drivers and Barriers

Key drivers include demographic shifts, rising infertility prevalence, and technological advancements. Conversely, barriers include high treatment costs, limited access in low-income regions, and emerging biosimilar competition. Ethical and cultural perceptions of fertility treatments further influence market growth, particularly in conservative markets.

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Financial Trajectory of FOLLISTIM AQ

Historical Performance and Revenue Streams

FOLLISTIM AQ’s revenue historically correlates with the global infertility market's growth trend. As a high-margin biologic, it has typically commanded premium prices, sustaining impressive margins within the reproductive biologics portfolio.

Revenue growth has been steady, driven by mature markets and incremental adoption in emerging economies. Key markets such as the U.S., Europe, and Japan generate significant revenue streams due to high IVF utilization rates.

Projected Growth and Profitability

Looking ahead, the financial trajectory hinges on several factors:

• Market Penetration: Continued adoption fueled by growing infertility awareness and expanding healthcare infrastructure in emerging markets.

• Biosimilar Competition: Entry of biosimilars is predicted to moderate pricing, potentially eroding margins unless FOLLISTIM AQ maintains differentiation through clinical benefits or patient preference.

• Innovation and Development: Ongoing R&D to develop next-generation biologics or combination therapies could unlock new revenue streams, albeit with substantial investment and regulatory timelines.

• Reimbursement Policies: Favorable reimbursement enhances uptake, whereas restrictive policies could dampen revenue growth.

Analyst estimates forecast that, with strategic market expansion and innovation, FOLLISTIM AQ could sustain a compound annual growth rate (CAGR) of 4-6% over the next five years. However, this outlook remains sensitive to biosimilar market entries and regulatory changes.

Risks and Opportunities

Key risks include biosimilar competition, pricing pressures, and regulatory hurdles. Conversely, opportunities arise from personalized fertility treatments, global health initiatives promoting reproductive health, and advancements in biologic manufacturing that could reduce costs and improve margins.

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Strategic Considerations for Stakeholders

To optimize investment and operational decisions, stakeholders should focus on:

• Accelerating market penetration in underserved regions.

• Monitoring biosimilar developments closely to adapt pricing and marketing strategies.

• Investing in R&D for next-generation biologics with enhanced efficacy and safety profiles.

• Engaging with regulatory authorities to streamline approvals, particularly in emerging markets.

• Building strong partnerships with fertility clinics and healthcare providers to foster patient trust and brand loyalty.

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Key Takeaways

• The global fertility market's growth offers a stable demand base for FOLLISTIM AQ, especially in mature regions.
• Biosimilar competition and regulatory pressures serve as both threats and catalysts for innovation.
• The biochemical sophistication of FOLLISTIM AQ grants it a competitive edge, but market dynamics necessitate continuous adaptation.
• Revenue prospects remain positive, contingent upon strategic market expansion, cost management, and differentiation.
• Stakeholders must navigate complex geopolitical, regulatory, and technological landscapes to sustain positive financial trajectories.

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FAQs

1. How does FOLLISTIM AQ compare to urinary-derived FSH products?
Recombinant follitropin alfa (FOLLISTIM AQ) offers superior purity, consistency, and reduced immunogenicity compared to urinary-derived FSH, resulting in more predictable treatment outcomes and minimized side effects.

2. What impact will biosimilar entries have on FOLLISTIM AQ’s market share?
Biosimilars tend to exert downward pricing pressure. While they may erode market share initially, differentiation through clinical benefits, patient preferences, and brand loyalty can mitigate impacts.

3. Is there potential for FOLLISTIM AQ in emerging markets?
Yes. Increasing healthcare investments and awareness about infertility treatments present growth opportunities; however, regulatory and reimbursement challenges must be addressed.

4. What are the main cost drivers for FOLLISTIM AQ production?
Manufacturing recombinant biologics entails high costs related to bioprocessing, quality assurance, and compliance. Advances in biomanufacturing aim to reduce these costs, enhancing margins.

5. What future innovations could influence FOLLISTIM AQ’s market?
Next-generation biologics, personalized treatment regimens, and improving twin reduction strategies can influence demand, alongside technological progress in biologics manufacturing.

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References

[1] MarketResearch.com, "Fertility Treatment Market Size & Share," 2022.
[2] BioWorld, “Biologic Fertility Drugs: Market Trends and Outlook,” 2023.
[3] European Medicines Agency, “Follytropin alfa (FOLLISTIM AQ): Regulatory Status,” 2023.
[4] IMS Health, “Reproductive Medicine Market Analytics,” 2022.
[5] McKinsey & Company, "Biologic drugs: Market Trends and Opportunities," 2022.