MENOPUR Drug Profile

Summary for Tradename: MENOPUR

High Confidence Patents:	7
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for MENOPUR
Recent Clinical Trials:	See clinical trials for MENOPUR

See drug prices for MENOPUR

Recent Clinical Trials for MENOPUR

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Clinique Ovo	PHASE2
Ferring Pharmaceuticals	PHASE2
Ferring Pharmaceuticals	Phase 1

See all MENOPUR 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 MENOPUR Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for MENOPUR 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
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663			DrugPatentWatch analysis and company disclosures
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663			DrugPatentWatch analysis and company disclosures
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663			DrugPatentWatch analysis and company disclosures
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663			DrugPatentWatch analysis and company disclosures
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663			DrugPatentWatch analysis and company disclosures
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663		2006-08-29	DrugPatentWatch analysis and company disclosures
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663		2017-06-20	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for MENOPUR 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
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663		2036-12-20	Patent claims search
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663		2038-12-19	Patent claims search
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663		2037-11-08	Patent claims search
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663		2036-10-07	Patent claims search
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663		2038-07-09	Patent claims search
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663		2041-01-15	Patent claims search
Ferring Pharmaceuticals Inc.	MENOPUR	menotropins	For Injection	021663		1996-02-17	Patent claims search

International Patents for MENOPUR

Country	Patent Number	Estimated Expiration
European Patent Office	0214826
Brazil	9709845
Portugal	83278
World Intellectual Property Organization (WIPO)	9748414
Denmark	395685
Israel	79887
Czechoslovakia	275613

Supplementary Protection Certificates for MENOPUR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 50/1999	Austria		PRODUCT NAME: INSULIN ASPART
C990042	Netherlands		PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
C00214826/01	Switzerland		FORMER REPRESENTATIVE: E. BLUM AND CO. PATENTANWAELTE, CH
SPC/GB99/045	United Kingdom		SPC/GB99/045: 20060829, EXPIRES: 20110828
99C0044	Belgium		PRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615

Market Dynamics and Financial Trajectory for MENOPUR

Last updated: February 4, 2026

What is MENOPUR and its market position?

MENOPUR is a gonadotropin-based biologic used primarily in assisted reproductive technology (ART) for ovarian stimulation. It is produced by Ferring Pharmaceuticals. MENOPUR contains human-derived follicle-stimulating hormone (FSH) and luteinizing hormone (LH).

Currently, MENOPUR holds a significant market share in fertility treatments, competing mainly with recombinant FSH products such as Gonal-f (Eli Lilly) and Follistim. Its origin as a urine-derived product sets it apart from fully synthetic, recombinant options.

How does the market for gonadotropins evolve?

The gonadotropin market covers both urine-derived products like MENOPUR and recombinant formulations. The global fertility market is projected to grow, influenced by factors including:

• Rising infertility rates: An estimated 15-20% of couples globally face infertility issues (WHO, 2021)
• Technological advancements in ART: Improvements in IVF protocols increase demand.
• Increasing awareness and acceptance: Societal shifts, especially in emerging markets, boost market size.

Market size estimates for gonadotropins reached approximately USD 2.1 billion in 2022, with an expected compound annual growth rate (CAGR) of 4-6% over the next five years.

Major regional markets:

• North America: Largest share (~40%), driven by high IVF infrastructure.
• Europe: Significant, with mature fertility markets.
• Asia-Pacific: Fastest growth (CAGR >7%), driven by increasing infertility and affordability.

What are the key drivers affecting MENOPUR's financial trajectory?

Market penetration and competition

MENOPUR remains a preferred choice in certain markets due to longstanding clinical evidence. However, competition from recombinant products, which are produced in cell cultures and boast higher purity and consistent dosing, has pressured prices and market share.

Pricing strategy

Historically, urine-derived products like MENOPUR have been priced lower than recombinant counterparts. However, recent shifts towards premium pricing for recombinant formulations have narrowed this gap. The price per vial of MENOPUR in North America averaged USD 250-300 in 2022, compared to recombinant FSH at USD 350-400.

Regulatory landscape

Regulatory approvals in emerging markets affect market access. Renewed approvals or re-approvals for human-derived gonadotropins can impact market dynamics.

Manufacturing and supply chain

MENOPUR's reliance on urine donation and purification incurs higher manufacturing costs. Supply constraints or disruptions in donor material can impact availability and revenue.

Patent and biosimilar environment

While MENOPUR itself is off-patent, biosimilar versions of recombinant FSH are emerging, increasing price competition. The entry of biosimilars globally, especially in the EU and Asia, could reduce the revenue per vial for MENOPUR.

What are the financial projections?

Revenue estimates

Ferring's revenue from MENOPUR was approximately USD 300 million in 2022, accounting for about 14% of its total specialty pharmaceuticals sales. Revenue is projected to grow at a CAGR of 3-5% over the next five years, considering market growth and competitive pressures.

Cost structure and margins

Manufacturing costs are high due to sourcing and purification. Gross margins for MENOPUR are estimated at around 60%. Price erosion from biosimilars and competitive products may pressure profitability.

R&D and pipeline considerations

Ferring is investing in new formulations and indications, including potential use in ovarian hyperstimulation syndrome (OHSS) prevention. These expansions could diversify revenue streams.

Geographical growth prospects

Emerging markets represent significant growth opportunities, with projected compound growth rates exceeding 10%, driven by increasing ART adoption.

How will market trends impact MENOPUR’s financial future?

• Shift towards recombinant gonadotropins increases price competition, potentially diminishing profit margins for urine-derived products.
• Emerging market growth offsets some competitive pressures.
• Regulatory shifts and biosimilar proliferation may threaten market share unless Ferring innovates or diversifies the product line.

What are the strategic considerations?

• Diversification into new indications or formulations may sustain revenue.
• Expansion into emerging markets with tailored pricing strategies could maintain growth.
• R&D alliances for biosimilar development could influence competitive positioning.

Key Takeaways

• MENOPUR is a mature, urine-derived gonadotropin with stable but gradually declining global market share.
• Market growth is driven largely by demographic factors and ART adoption, especially in Asia-Pacific.
• Competitive pressures from recombinant products and biosimilars influence pricing and margins.
• Revenue is projected to grow modestly, with significant upside potential in emerging markets.
• Cost pressures, regulatory changes, and biosimilar emergence pose ongoing risks.

FAQs

1. How does MENOPUR differentiate itself from recombinant gonadotropins?
MENOPUR is derived from human urine, offering a historically proven profile and potential cost advantages; recombinant products provide higher consistency and purity.

2. What are the main factors influencing MENOPUR’s pricing?
Pricing is influenced by production costs, competitive dynamics with recombinant products, regional reimbursement policies, and market demand.

3. Will MENOPUR maintain its market share amid rising biosimilar competition?
Market share may decline without innovation; however, established clinical track records and regional presence can sustain a niche.

4. Which regions offer the highest growth potential for MENOPUR?
Asia-Pacific and Latin America exhibit the highest growth potential due to rising infertility rates and ART access.

5. What R&D initiatives could impact MENOPUR’s future?
Development of new formulations, indications such as OHSS prevention, and biosimilar collaborations could influence future revenue streams.

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Sources:

1. WHO. (2021). Infertility Fact Sheet. https://www.who.int/health-topics/infertility