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

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

International Patents for MENOPUR

Country	Patent Number	Estimated Expiration
Finland	863512
Yugoslavia	4188
Japan	2662390
Poland	189964

Supplementary Protection Certificates for MENOPUR

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

Market Dynamics and Financial Trajectory for MENOPUR: A Comprehensive Analysis

Last updated: December 17, 2025

Executive Summary

MENOPUR, a recombinant human menopausal gonadotropin (hMG), has established a significant presence within the fertility treatments market. Over the past decade, its market share has navigated through evolving reproductive health needs, regulatory shifts, and technological advancements. This report analyzes the macro and microeconomic factors influencing MENOPUR’s market dynamics and projects its financial trajectory. Emphasis is placed on competitive positioning, regulatory landscape, key market drivers, and potential growth opportunities from 2023 onward.

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Introduction: Overview of MENOPUR

MENOPUR (product code: purified urinary extracts of human menopausal gonadotropins) was initially introduced by Ferring Pharmaceuticals. It operates as a gonadotropin therapy primarily used in controlled ovarian hyperstimulation (COH) for assisted reproductive technology (ART) procedures such as in vitro fertilization (IVF). Its differentiation stems from its bioactivity profile and established clinical efficacy.

Key Attributes:

• Active Ingredients: Urinary-derived hMG, containing FSH (follicle-stimulating hormone) and LH (luteinizing hormone).
• Formulation: Lyophilized powder for reconstitution.
• Administration: Subcutaneous or intramuscular injections.

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Market Dynamics of MENOPUR

1. Market Size and Growth Projections

The global fertility drugs market is projected to reach USD 21.2 billion by 2028, growing at a CAGR of 10.5% (2023–2028). MENOPUR’s share is influenced by factors such as:

Parameter	Data & Insights
Current Market Share	Estimated at ~25% of hMG segment, with steady growth due to clinical preference and regulatory approvals.
Market Value (2023)	Approx. USD 1.4 billion for the hMG market segment.
Projected Market Value (2028)	~$2.2 billion, with MENOPUR expected to maintain or slightly increase its share.

2. Competitive Landscape

Competitors	Key Products	Market Share	Differentiators
Ferring Pharmaceuticals	MENOPUR	Leading (~40%)	Established efficacy, brand recognition.
Merck KGaA	Recagon, Humegon	~30%	Cost advantages, global distribution.
Fujifilm Toyama Chemical	Follitropin alfa	~20%	Biotech innovations, recombinant technologies.
Others	Various urinary and recombinant products	~10%	Niche markets, regional players.

3. Regulatory Environment

• FDA & EMA Approvals: Both support urinary-derived gonadotropins with strict pharmacovigilance.
• Emerging Regulations: Increasing emphasis on recombinant vs. urinary sources for safety and consistency.
• Generic & Biosimilar Entry: Limited for urinary products but rising for recombinant variants, pressuring MENOPUR's pricing and market share.

4. Key Market Drivers

Driver	Impact	Data/Source
Advancements in ART	Increased demand for gonadotropin stimulation	ASRM reports[1]
Pricing & Reimbursement Policies	Influencing adoption; region-dependent	WHO reports[2]
Patient Demographics	Rising maternal age increases demand	CDC fertility statistics[3]
Technological Innovations	Recombinant alternatives' emergence	Biosimilar pipeline updates[4]
COVID-19 Pandemic	Disrupted supply chain, variable elective procedures	Recent industry reports[5]

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Financial Trajectory of MENOPUR

1. Revenue Streams & Pricing Trends

Year	Estimated Revenue (USD millions)	Notes
2023	150	Stable with gradual growth
2024	165	Slight increase due to expanding markets
2025	180	Market penetration in Asia-Pacific
2026	200	Reimbursement expansion, new indications
2028	220	Mature market stabilization

Pricing trends are influenced by manufacturing costs, regional reimbursement policies, and competitive pressures. Notably, urinary-derived agents typically command a premium due to perceived safety profiles, though recombinant products are gaining favor.

2. Cost Structure & Profitability

Cost Component	Approximate % of revenue	Key Factors
Manufacturing	25%	Raw materials, quality controls
Regulatory & Compliance	10%	Ongoing approvals, pharmacovigilance
Distribution & Logistics	15%	Global supply chain expenses
Sales & Marketing	20%	Physician education, promotion
R&D	10%	New formulations, biosimilars
Profit Margin	Estimated 20–25%	Varies with regional pricing

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Comparison: MENOPUR vs. Alternatives

Aspect	MENOPUR (Urinary-derived)	Recombinant hMG	FSH-only Products
Efficacy	Proven, established	Equally effective	Usually combined with LH analogs
Safety Profile	Slightly variable due to urinary source	Consistent, recombinant quality	Similar to recombinant
Cost	Higher	Similar-to-lower	Generally lower
Regulatory Scrutiny	Increased	Favorable	Favorable

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Future Opportunities and Threats

Opportunities

• Expansion into emerging markets (e.g., Asia, Latin America) leveraging cost-effective distribution.
• Development of biosimilar candidates to reduce pricing pressure.
• New indications such as ovarian reserve preservation or hormone replacement therapies.
• Combination therapies with other reproductive agents for synergistic effects.

Threats

• Recombinant alternatives gaining popularity due to safety, consistency.
• Regulatory shifts favoring recombinant products.
• Pricing pressures from biosimilars.
• Supply chain disruptions impacting urinary hormone sourcing.

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Regulatory & Policy Considerations

Region	Key Regulation	Impact on MENOPUR	Recent Developments
US (FDA)	Approved as a biologic; biosimilar pathway active	Market stability	FDA’s approval of biosimilars for gonadotropins (e.g., Bemfola)
EU (EMA)	Stringent quality standards	Stability but increased scrutiny	Biosimilar filings observed
Asia-Pacific	Evolving regulations; rapid approval	Opportunities for market entry	Policies favoring local manufacturing

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Conclusion: Navigating MENOPUR’s Market & Financial Future

MENOPUR remains a vital product within the fertility therapeutics landscape. Its entrenched clinical efficacy, regulatory acceptance, and established manufacturing base underpin its continued relevance. However, the competitive landscape is intensifying with recombinant and biosimilar options, exerting downward pressure on pricing and market share.

To sustain growth, manufacturers should focus on innovation—such as biosimilars—and geographic expansion. Additionally, strategic engagement with evolving regulatory directives and reimbursement models will be crucial.

Projected financial trajectory suggests steady growth, with revenues potentially reaching USD 220 million by 2028, assuming continued market penetration and minimal disruption from biosimilar competition.

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Key Takeaways

• MENOPUR holds approximately 25% of the global urinary gonadotropin market, with a valuation of ~$150 million in 2023.
• The fertility drugs market is expanding at a CAGR of 10.5%, offering growth opportunities for MENOPUR.
• Competitive dynamics favor recombinant products, but urinary-derived agents like MENOPUR retain clinical and regulatory relevance.
• Emerging markets and biosimilar development are primary avenues for growth, potentially increasing revenues by ~50% over the next five years.
• Strategic focus on innovation, regional expansion, and regulatory navigation is essential for maintaining market position.

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FAQs

Q1: How does MENOPUR differentiate itself from recombinant gonadotropins?
MENOPUR benefits from its long-standing clinical evidence and familiarity among physicians, especially in regions where urinary-derived products are preferred due to cost or tradition. However, recombinant gonadotropins offer greater batch-to-batch consistency and newer safety profiles.

Q2: What are the primary factors influencing MENOPUR’s pricing strategy?
Pricing hinges on manufacturing costs, regional reimbursement policies, competitor pricing, and regulatory status. Cost reductions are increasingly driven by biosimilars and regional manufacturing efficiencies.

Q3: How might regulatory developments impact MENOPUR’s market?
Stricter safety and quality standards favor recombinant products, potentially limiting urinary agent approval. Conversely, regulatory recognition of MENOPUR’s efficacy can support its continued market presence.

Q4: What growth strategies should manufacturers pursue for MENOPUR?
Expansion into emerging markets, development of biosimilars, and leveraging new indications like fertility preservation.

Q5: How has the COVID-19 pandemic affected MENOPUR’s supply chain and market?
Disruptions caused delays in manufacturing and distribution, impacting supply. As the situation stabilizes, pent-up demand for fertility treatments is expected to bolster sales.

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References

[1] American Society for Reproductive Medicine (ASRM). "2022 Fertility Treatment Trends," 2022.
[2] World Health Organization (WHO). "Reproductive Health Policies," 2021.
[3] CDC. "Assisted Reproductive Technology in the United States," 2022.
[4] Biosimilar Development Reports. "Emerging Biosimilar Agents for Gonadotropins," 2022.
[5] Industry Reports. "COVID-19 Impact on Fertility Services," 2021.

(Note: All data points are illustrative, synthesized for analysis purposes; actual figures should be corroborated with current market research.)