FOLLISTIM AQ CARTRIDGE Drug Profile

Summary for Tradename: FOLLISTIM AQ CARTRIDGE

High Confidence Patents:	8
Applicants:	1
BLAs:	1

Pharmacology for FOLLISTIM AQ CARTRIDGE

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 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 CARTRIDGE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for FOLLISTIM AQ CARTRIDGE 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 Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	10,656,152	2037-11-08	DrugPatentWatch analysis and company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	10,786,662	2038-01-05	DrugPatentWatch analysis and company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	10,912,714	2038-07-09	DrugPatentWatch analysis and company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	5,767,251	2013-01-22	DrugPatentWatch analysis and company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	5,929,028	2018-04-14	DrugPatentWatch analysis and company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	7,446,090	2026-07-07	DrugPatentWatch analysis and company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	7,563,763	2025-08-26	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for FOLLISTIM AQ CARTRIDGE 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 Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	10,016,338	2036-12-20	Patent claims search
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	10,182,561	2036-06-14	Patent claims search
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	10,577,154	2038-12-19	Patent claims search
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	10,656,152	2037-11-08	Patent claims search
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	10,786,662	2038-01-05	Patent claims search
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	10,912,714	2038-07-09	Patent claims search
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211	11,298,293	2041-01-15	Patent claims search

International Patents for FOLLISTIM AQ CARTRIDGE

Country	Patent Number	Estimated Expiration
Portugal	853945
China	110074968
Argentina	082615
Canada	2803613
China	103328026
Russian Federation	2550452
Japan	3091673

Supplementary Protection Certificates for FOLLISTIM AQ CARTRIDGE

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
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 for Follistim AQ Cartridge

Last updated: September 26, 2025

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Introduction

Follistim AQ Cartridge represents a prominent entrant within the recombinant human follicle-stimulating hormone (FSH) class, used predominantly in assisted reproductive technology (ART). As a subcutaneous injection, it offers an alternative to traditional recombinant FSH therapies, with significant implications for pharmaceutical markets, healthcare providers, and patients. This analysis explores the intricate market forces shaping Follistim AQ Cartridge's trajectory, encompassing competitive dynamics, regulatory influences, technological innovations, pricing considerations, and emerging trends.

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Market Overview and Product Positioning

Follistim AQ, developed by Merck KGaA (licensed to Ferring Pharmaceuticals in certain markets), is utilized chiefly for controlled ovarian hyperstimulation across infertility treatments. Its unique formulation in a cartridge simplifies administration, aligning with the broader shift towards user-friendly biologics. The product’s distinctive attributes, including pre-measured dosing and compatibility with pen devices, bolster its position in outpatient clinics and fertility centers, addressing the growing demand for minimally invasive, patient-centric therapies.

Biologic therapeutics, such as Follistim AQ, have experienced sustained market growth owing to their targeted mechanism of action and high efficacy. The global fertility market is projected to expand at a compound annual growth rate (CAGR) exceeding 10% over the forthcoming decade, driven by demographic shifts, technological advances, and expanding insurance coverage. For Follistim AQ specifically, this growth is punctuated by rising prevalence of infertility and increasing acceptance of in vitro fertilization (IVF).

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Competitive Landscape and Market Dynamics

1. Key Competitors and Market Share

Follistim AQ operates within a competitive landscape comprising other recombinant FSH products:

• Gonal-f (follitropin alfa): Market leader, with extensive clinical acceptance.
• Puregon (follitropin beta): Prominent in Europe.
• Recombinant human FSH biosimilars: Emerging entries such as Fostimon and Bemfola, which exert downward pressure on prices and margins.

The entry of biosimilars, approved across various jurisdictions, challenges the traditional monopsony power of originator biologics. Biosimilars often offer comparable efficacy at reduced costs, compelling competitors to innovate and differentiate (e.g., formulation improvements, delivery devices).

2. Pricing, Reimbursement, and Access

Pricing strategies underpin Follistim AQ's financial health. The cartridge format, by enhancing ease of use and reducing waste, potentially justifies a premium over pre-filled vials, bolstering margins. However, reimbursement policies vary globally. Countries with nationalized healthcare systems impose cost controls, which limit profitability unless offset by volume.

In the U.S., insurer negotiations, Medicaid policies, and patient assistance programs collectively influence net revenues. As IVF procedures are often elective, insurance coverage disparities affect demand growth for biologics like Follistim AQ.

3. Regulatory and Patent Environment

Intellectual property rights are pivotal. Follistim AQ benefits from patent exclusivity, which extends protection against biosimilars and generics until around 2035. Regulatory pathways for biosimilar approval, including the US FDA’s Biologics Price Competition and Innovation Act (BPCIA), foster market entry but require substantial investment in demonstrating biosimilarity.

Regulatory hurdles, coupled with stringent manufacturing standards, ensure product authenticity and safety but may delay biosimilar proliferation, temporarily sustaining Follistim AQ’s market dominance.

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Technological Innovations and Market Expansion

1. Delivery Devices and Formulation Advancements

Follistim AQ’s cartridge format, compatible with pen injectors, exemplifies innovations aimed at improving patient compliance and reducing administration errors. Ongoing research seeks to develop auto-injectors with digital interfaces, integrating dose tracking and remote monitoring—features increasingly valued in fertility treatments.

2. Personalization and Companion Diagnostics

Advancements in genomics afford potential for personalized stimulation protocols, optimizing Follistim AQ dosages based on ovarian reserve markers. Such tailored approaches can enhance efficacy, reduce adverse events, and expand clinical usage, broadening market potential.

3. Geographic Expansion

Emerging markets in Asia-Pacific, Latin America, and the Middle East exhibit heightened fertility treatment adoption. Factors like urbanization, economic development, and evolving healthcare infrastructure offer growth avenues for Follistim AQ. Regulatory acceptance in these regions continues to improve, facilitating wider market penetration.

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Financial Trajectory and Revenue Prospects

1. Revenue Drivers

The financial outlook for Follistim AQ hinges on:

• Market Penetration: Expansion into new geographies and increased adoption in existing markets.
• Pricing Power: Leveraging device advantages to command premium pricing.
• Volume Growth: Rising infertility prevalence, especially influenced by aging populations and lifestyle factors.

2. Cost Structure and Margins

Manufacturing biologics entails high fixed costs, including cell culture processes, purification, and stringent quality controls. The cartridge format, while enhancing patient convenience, may entail higher production costs compared to vials. Nevertheless, economies of scale and process innovations are anticipated to improve margins over time.

3. Competitive Discounting and Biosimilar Impact

The susceptibility to biosimilar competition exerts downward pressure on revenue streams. Strategic responses may include product differentiation, enhanced service offerings (e.g., patient support), and proactive patent litigations.

4. Investment and R&D

Continued investment in next-generation formulations, delivery devices, and personalized medicine will be essential for sustaining growth. Additionally, R&D in expanding indications (e.g., ovarian failure, male infertility) may unlock new revenue streams.

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Market Challenges and Risks

• Regulatory Delays and Changes: Shifts in approval standards or reimbursement policies can impact sales forecasts.
• Pricing Pressures: Rising biosimilar competition pressures margins, especially in price-sensitive markets.
• Clinical and Operational Risks: Manufacturing disruptions or quality issues could impair supply and reputation.
• Market Saturation: Mature markets nearing saturation limit future growth, emphasizing importance of geographic expansion.

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Emerging Trends and Future Outlook

The outlook for Follistim AQ involves a confluence of technological evolution, regulatory adaptation, and demographic shifts. Adoption of digital health tools, synchronization with fertility clinics’ electronic records, and personalized dosing protocols will facilitate differentiation. Additionally, collaborations with biotech firms to develop advanced delivery systems could unlock new market segments.

The global fertility market’s projected CAGR exceeding 10% suggests robust growth prospects, with biologics like Follistim AQ poised to benefit from increasing demand for fertility treatments. Overall, the product’s financial trajectory appears promising, contingent upon strategic positioning amidst evolving competitor landscapes, regulatory climates, and technological innovations.

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Key Takeaways

• Market Expansion: Regulatory approval and market entry in emerging regions, coupled with increasing infertility rates, underpin growth potential.
• Competitive Positioning: Differentiation through device innovation and patient-centric formulations enhances market share; biosimilar competition remains a significant headwind.
• Pricing Strategies: Premium cartridge formulations support favorable margins but require balancing affordability with reimbursement realities.
• Innovation Focus: Investment in digital therapeutics, personalization, and advanced delivery systems can sustain product relevance.
• Regulatory and Market Risks: Vigilant management of patent protections, regulatory compliance, and market access strategies are vital for long-term success.

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FAQs

1. How does the Follistim AQ Cartridge differ from traditional formulations?
Follistim AQ in a cartridge offers simplified dosing, ease of use via pen devices, and reduced waste, improving patient compliance and clinician convenience compared to standard vials.

2. What are the primary factors influencing the pricing of Follistim AQ?
Pricing is influenced by manufacturing costs, device innovations, competition from biosimilars, reimbursement policies, and market demand.

3. How will biosimilars impact Follistim AQ’s market share?
Biosimilars pose a significant threat by offering comparable efficacy at lower prices, potentially eroding market share unless Follistim AQ differentiates through innovation or enhanced services.

4. What opportunities exist for geographic expansion of Follistim AQ?
Emerging markets in Asia, Latin America, and Africa, driven by rising infertility and evolving healthcare infrastructure, present promising opportunities for growth.

5. What technological trends could shape the future of Follistim AQ?
Development of auto-injectors with digital tracking, personalized dosing approaches, and integration with electronic health records are key technological trends.

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References

1. Market research reports on global fertility treatments and biologic therapeutics.
2. Regulatory data on biosimilar approvals and patent life cycles.
3. Company disclosures and press releases from Merck KGaA and Ferring.
4. Industry analyses on biologic drug pricing, reimbursement, and market entry strategies.
5. Academic literature on technological advancements in biologic drug delivery.