Follitropin beta - Biologic Drug Details

Summary for follitropin beta

Tradenames:	3
High Confidence Patents:	4
Applicants:	2
BLAs:	3
Suppliers: see list	2

Pharmacology for follitropin beta

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 brand-side disclosures

These patents were identified from searching 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 follitropin beta Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for follitropin beta 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

3) Low Certainty: US Patents for follitropin beta 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	10,016,338	2036-12-20	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582	10,182,561	2036-06-14	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582	10,577,154	2038-12-19	Patent claims search
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	FOLLISTIM	follitropin beta	For Injection	020582	10,656,152	2037-11-08	Patent claims search

International Patents for follitropin beta

Country	Patent Number	Estimated Expiration
Austria	E190461
Spain	2533312
Luxembourg	90770
World Intellectual Property Organization (WIPO)	2021247665

Supplementary Protection Certificates for follitropin beta

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 13/2001	Austria		PRODUCT NAME: LUTROPIN ALFA
SZ 17/2001	Austria		PRODUCT NAME: CHORIOGONADOTROPHIN ALFA
SPC/GB10/022	United Kingdom		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTERED: UK EU/1/09/609/001 20100125; UK EU/1/09/609/002 20100125
C300440	Netherlands		PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125; FORMER OWNER: N.V. ORGANON, NL

Follitropin beta Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for Follitropin Beta?

Follitropin beta is a recombinant form of follicle-stimulating hormone (FSH) used primarily in fertility treatments. Its market is influenced by multiple factors, including demographic trends, regulatory pathways, competitive landscape, and technological advancements.

Market Drivers

• Rising infertility rates: Globally, infertility affects approximately 8-12% of reproductive-age couples, with higher prevalence in developed countries [1].
• Advancements in assisted reproductive technologies (ART): Increased adoption of in vitro fertilization (IVF) protocols drives demand for gonadotropins, including follitropin beta.
• Product differentiation: Follitropin beta is distinguished from follitropin alfa by production processes and biosimilar market entries, impacting pricing and market share.
• Healthcare policy and reimbursement: Favorable policies in developed markets improve accessibility, stimulating growth.

Competitive Landscape

• Major players: Ferring Pharmaceuticals, Merck Serono (Merck KGaA), and Teva Pharmaceuticals dominate the follitropin market.
• Generics and biosimilars: Entry of biosimilars post-patent expiry has intensified competition and led to pricing pressures.
• Product launch and pipeline: New formulations (e.g., long-acting versions) and biosimilar approvals are upcoming market influences.

Regulatory Environment

• Approval pathways: Regulatory approvals by EMA, FDA, and other agencies shape market entry.
• Pricing and reimbursement policies: Variations across geographies affect sales volume and revenue potential.

Market Size and Growth Rate

• The global gonadotropins market, including follitropin beta, was valued at approximately USD 1.8 billion in 2022.
• An estimated compound annual growth rate (CAGR) of 4-6% is projected from 2023 to 2030, driven primarily by fertility treatment demand [2].

Key Regional Markets

Region	Market Share (2022)	Growth Drivers
North America	35%	High fertility treatment rates, reimbursed procedures
Europe	30%	Well-established ART infrastructure, regulatory approvals
Asia-Pacific	20%	Increasing fertility awareness, rising healthcare spending
Latin America	8%	Expanding ART centers, improved healthcare access
Middle East & Africa	7%	Growing medical tourism, increasing fertility clinics

---

What Is the Financial Trajectory for Follitropin Beta?

Follitropin beta’s financial outlook reflects market growth, pricing strategies, patent landscapes, and biosimilar competition.

Revenue Modeling

• Historical revenue estimates: Sessional revenues for leading brands ranged from USD 150 million to USD 300 million annually in core markets.
• Projected revenue growth: Assuming mid-range market expansion, revenues could increase by USD 50 million–USD 100 million annually over the next five years.

Price Trends and Market Share

• Pricing dynamics: Branded follitropin beta prices hover around USD 300–USD 500 per injection, depending on jurisdiction.
• Biosimilar impact: Biosimilar entries have reduced prices by approximately 30-50%. Some markets have seen a decrease in per-unit price while volume increases compensate for lower per-unit margins.

Profitability Factors

• Manufacturing costs: Approximately 20-25% of revenue.
• Regulatory cost burden: Post-approval pharmacovigilance and compliance, contributing to operating expenses.
• Pricing regulations: Government-imposed price caps in several regions can suppress margins.

Investment and R&D Funding

• Pipeline investments: Major manufacturers invest USD 10-50 million annually in R&D for next-generation formulations and biosimilars.
• Intellectual property rights: Patent expirations for key formulations are expected between 2024–2029, influencing pricing and generic entry.

Key Financial Indicators (Estimates, 2022–2027)

Year	Revenue (USD millions)	CAGR (%)	Operating Margin (%)	Market Share (%)
2022	250	-	30	60
2023	260	4	30	62
2024	273	5	28	65
2025	290	6	27	67
2026	305	5.2	26	70
2027	320	4.9	25	72

---

Key Takeaways

• Market growth around 4-6% per year driven by increasing infertility treatments and ART adoption.
• Biosimilar competition exerts downward pressure on prices but may expand overall market volume.
• Regional expansion, especially in Asia-Pacific and Latin America, offers future revenue opportunities.
• Patent expirations from 2024 onward potentially introduce significant generics and biosimilars, affecting profitability.
• R&D investments are crucial for maintaining competitive advantage amid rising pipeline activity.

---

FAQs

1. How do biosimilars impact follitropin beta sales?
Biosimilars reduce prices by 30-50%, increasing market volume but lowering per-unit revenues, leading to potential shifts in market share and profit margins.

2. What regulatory hurdles exist for follitropin beta?
Regulatory agencies require demonstration of biosimilarity, biosafety, and manufacturing consistency, especially for biosimilar entrants. Variability across regions in approval standards affects market access.

3. Which markets are expected to see the fastest growth?
Asia-Pacific and Latin America are projected to have higher growth rates due to expanding healthcare infrastructure and increased fertility awareness.

4. How does patent expiration influence the market?
Patent expirations between 2024–2029 will open markets for biosimilars, intensifying competition and potentially decreasing prices.

5. What are the key areas of innovation in follitropin beta?
Long-acting formulations, improved biosimilars, and combination therapies with other reproductive hormones are primary R&D focus areas.

---

References

[1] World Health Organization. Infertility fact sheet, 2022.
[2] MarketsandMarkets. Gonadotropins Market Report, 2023.