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		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
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2038-07-09	DrugPatentWatch analysis and company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2013-01-22	DrugPatentWatch analysis and company disclosures
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2018-04-14	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		2036-12-20	Patent claims search
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2036-06-14	Patent claims search
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2038-12-19	Patent claims search
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2037-11-08	Patent claims search
Organon Usa Llc, A Subsidiary Of Organon & Co.	FOLLISTIM AQ CARTRIDGE	follitropin beta	Injection	021211		2038-01-05	Patent claims search

International Patents for FOLLISTIM AQ CARTRIDGE

Country	Patent Number	Estimated Expiration
Australia	2014202862
European Patent Office	0974359
World Intellectual Property Organization (WIPO)	2012003221
European Patent Office	3437743
Denmark	2600930

Supplementary Protection Certificates for FOLLISTIM AQ CARTRIDGE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
10C0024	France		PRODUCT NAME: CORIFOLLITROPINE ALPHA; REGISTRATION NO/DATE: EU/1/09/609/001 20100125
SPC/GB96/011	United Kingdom		PRODUCT NAME: RECOMBINANT HUMAN FOLLICLE STIMULATING HORMONE; REGISTERED: FI 11529 19940815; FI 11530 19940815; UK EU/1/95/001 19951020; UK EU/1/95/002 19951020; UK EU/1/95/003 19951020; UK EU/1/95/004 19951020; UK EU/1/95/005 19951020; UK EU/1/95/006 19951020; UK EU/1/95/007 19951020; UK EU/1/95/008 19951020; UK EU/1/95/009 19951020; UK EU/1/95/010 19951020; UK EU/1/95/011 19951020; UK EU/1/95/012 19951020; UK EU/1/95/013 19951020; UK EU/1/95/014 19951020; UK EU/1/95/015 19951020; UK EU/1/95/016 19951020
SZ 13/2001	Austria		PRODUCT NAME: LUTROPIN ALFA
SPC019/2010	Ireland		SPC019/2010: 20101001, EXPIRES: 20230112
426	Finland

FOLLISTIM AQ CARTRIDGE: Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

What is FOLLISTIM AQ CARTRIDGE and what demand signals matter for its market dynamics?

Follistim AQ Cartridge (follitropin beta) is a gonadotropin used for controlled ovarian stimulation (COS) in fertility care and, in certain jurisdictions/labels, for male hypogonadotropic hypogonadism. Market dynamics for this class are driven less by “winner-takes-most” innovation cycles and more by treatment protocols, payer coverage, clinic purchasing behavior, and biosimilar/alternative competitive supply.

Key demand signals that typically govern unit volume and revenue growth/decline in this category:

• Fertility procedure volumes (cycle counts) tied to demographic demand and utilization rates.
• Insurance/payer formulary status and prior authorization burden for injectable gonadotropins.
• Protocol shifts (dose titration approaches, cartridge vs pen/other delivery formats, and procurement contracts).
• Concentration and switching pressure from comparable products and biosimilars.
• Regulatory and supply continuity (manufacturing scale-ups, batch release performance, and episodic shortages that affect clinics’ continuity of care).

How has the competitive landscape typically evolved for follitropin products?

This market sits inside a broader fertility biologics segment that has repeatedly shown:

• Therapy substitution risk (clinics and payers can switch among gonadotropins when acquisition cost and formulary access change).
• Price pressure as competitors enter and as procurement contracts reset.
• Reduced brand pricing power over time when multiple follitropin options are available in the same therapeutic niche.

For follitropin beta specifically, commercial outcomes depend on whether the product holds:

• Long-term formulary access at major payers and PBMs,
• Channel stability (wholesale ordering patterns and clinic contracting),
• Relative pricing versus alternatives (other follitropins and competing stimulation protocols),
• Supply reliability that prevents clinics from changing brands mid-cycle.

What market dynamics affect pricing and contract economics for FOLLISTIM AQ?

Fertility injectables typically operate under a contract and reimbursement regime that creates four recurring economic dynamics:

1. Net price compression: gross-to-net changes through rebates, payer contracts, and pharmacy benefit structures.
2. BI-to-BI substitution pressure: clinics can shift between gonadotropins when the clinical workflow remains manageable and reimbursement coverage is stable.
3. Regional payer variation: formularies differ by country, line of therapy, and patient eligibility rules.
4. Procurement-driven switching: larger fertility networks and hospital formularies can realign procurement when pricing changes.

For FOLLISTIM AQ specifically, cartridge format matters because it influences:

• Clinic dispensing workflow (storage, unit handling, dosing measurement),
• Inventory turns (wastage risk and time-to-patient matching),
• Conversion rates when a clinic moves between branded products or between delivery devices.

What is the revenue trajectory pattern historically seen in follitropin brands?

Without jurisdiction-specific filings and up-to-date unit economics for FOLLISTIM AQ, the most decision-relevant trajectory pattern in this class is:

• Initial growth on established clinical uptake and formulary access,
• Plateau/volatility when payer coverage tightens or competitors expand,
• Downward drift in growth rate as alternative gonadotropins and biosimilar-like competition increase switching risk,
• Mid-cycle revenue swings driven by supply continuity and seasonal procedure scheduling.

That trajectory is consistent with how gonadotropin markets price and contract: volume depends on cycle starts, and revenue depends on net price after payer concessions.

What financial mechanics determine whether FOLLISTIM AQ expands or contracts?

The financial trajectory for this biologic is a function of:

Volume drivers

• Cycle starts / demand for COS in approved indications
• Market share under switching conditions
• Clinic adoption rate in new networks and geographies

Pricing and net revenue drivers

• Net price after rebates and payers
• Tendering outcomes in hospital systems
• WAC-to-net spreads driven by formulary placement

Cost and margin drivers

• Manufacturing scale efficiency (batch yields and line utilization)
• Logistics and cold chain costs tied to presentation
• Regulatory and quality costs that can rise with lifecycle management

What are the near-term market risks that can shift the financial trajectory?

The most material risk categories for follitropin biologics include:

• Formulary loss or restriction: prior authorization tightening, step therapy rules, or requirement to use an alternative within the class.
• Competitor undercutting: price renegotiations triggered by competitor entry or tender wins.
• Supply disruptions: manufacturing downtime or distribution constraints that force temporary switching.
• Utilization shocks: fertility clinic closures, shifts in elective procedure demand, or changes in reimbursement criteria.
• Regulatory lifecycle events: label changes, risk-management updates, or post-marketing commitments that affect distribution.

What are the opportunity levers that can improve financial outcomes?

Financial upside is usually limited, execution-heavy, and linked to channel access:

• Payer re-expansion in high-volume accounts (major PBMs and hospital systems)
• Protocol-alignment initiatives that reduce switching friction at the clinic level
• Contract renewals that stabilize net price and minimize tender-driven churn
• Geographic scaling where formulary status is not yet saturated

How should investors and R&D planners read the trajectory signals for FOLLISTIM AQ?

For decision-making, the most action-relevant indicators are not generic fertility market growth rates, but rather:

• Share stability in COS prescribing and dispensing channels
• Net price trajectory in major payer agreements
• Claims behavior: rebound or decline in prescription fills in key geographies
• Tender outcomes in hospital networks and managed care formularies
• Supply continuity: whether the product maintains fulfillment without increasing substitute switching

Key Takeaways

• FOLLISTIM AQ Cartridge (follitropin beta) sits in a biologic fertility class where reimbursement, tendering, and switching pressure drive the financial outcome more than incremental clinical differentiation.
• The typical trajectory pattern for follitropin brands is growth or plateau followed by net price pressure and share risk as competitive supply expands and payer restrictions increase.
• The financial trajectory is most sensitive to formulary status, net price compression, and supply continuity, with utilization shocks and tender wins driving near-term variance.
• Upside is achievable through payer and hospital contract stabilization plus reduced switching friction across clinics that use cartridge workflows.

FAQs

1) Is FOLLISTIM AQ Cartridge more volume- or price-driven in revenue?

In this class, revenue is usually both, but price and net revenue compression from contracting often determines whether volume growth translates into growth in revenue.

2) What event most directly causes abrupt revenue changes for gonadotropin brands?

Supply interruptions or formulary/payer step restrictions can cause immediate switching and thus abrupt claims and net sales changes.

3) How does the cartridge presentation affect commercial performance?

Cartridge format affects clinic dispensing workflow, inventory handling, and wastage risk, which can influence switching willingness when contracting changes.

4) What competitive threat is most likely for follitropin beta products?

Within-class switching driven by formulary access and procurement pricing, rather than dramatic clinical displacement.

5) What KPIs best forecast FOLLISTIM AQ financial trajectory?

Track share stability in prescribing/claims, net price in payer cohorts, fill/fulfillment reliability, and tender outcomes in large hospital networks.

References

[1] European Medicines Agency (EMA). Follitropin beta product information (Follistim AQ Cartridge). EMA product and assessment pages.
[2] U.S. Food and Drug Administration (FDA). Product labeling and prescribing information for follitropin beta products. FDA label database.
[3] GlobalData / IQVIA style industry reporting on gonadotropin market access dynamics (formulary, tendering, fertility utilization). Industry market access and procurement trend reports.