Menotropins - Biologic Drug Details

Summary for menotropins

Tradenames:	4
High Confidence Patents:	2
Applicants:	3
BLAs:	4
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for menotropins

Recent Clinical Trials for menotropins

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Kuban State Medical University	Phase 2
Assiut University	N/A
Ferring Pharmaceuticals	Phase 3

See all menotropins 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 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 menotropins Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for menotropins 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		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 menotropins 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
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646		2036-12-20	Patent claims search
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646		2038-12-19	Patent claims search
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646		2037-11-08	Patent claims search
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646		2036-10-07	Patent claims search
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646		2038-07-09	Patent claims search

International Patents for menotropins

Country	Patent Number	Estimated Expiration
Japan	2000513344
Finland	102182
Austria	E113061
Canada	2258097
Australia	593274

Supplementary Protection Certificates for menotropins

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
C990042	Netherlands		PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
SZ 50/1999	Austria		PRODUCT NAME: INSULIN ASPART
C00214826/01	Switzerland		FORMER REPRESENTATIVE: E. BLUM AND CO. PATENTANWAELTE, CH

Market Dynamics and Financial Trajectory for Menotropins

Last updated: July 28, 2025

Introduction

Menotropins, a class of biologic drugs derived from human menopausal gonadotropins, serve a pivotal role in assisted reproductive technologies (ART) and fertility treatments. These complex biologics mimic natural pituitary hormones—follicle-stimulating hormone (FSH) and luteinizing hormone (LH)—to stimulate ovulation in women with infertility issues and enhance spermatogenesis in men. As the global demand for fertility treatments surges, understanding the underlying market dynamics and financial trajectory of menotropins offers valuable insights for stakeholders across pharmaceutical, biotech, and healthcare sectors.

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Market Overview and Current Landscape

The menotropins market is characterized by a relatively niche but steadily expanding footprint within the broader reproductive health pharmaceuticals sector. Leading players include Ferring Pharmaceuticals, Merck KGaA, and IBSA Farmaceutici Italia, which produce well-established brands such as Pergonal and Menopur. The biologic’s market landscape is defined by high barriers to entry, stemming from complex manufacturing processes, stringent regulatory standards, and patent protections.

Global revenue for the fertility drugs market, which encompasses menotropins, was valued at approximately USD 4.3 billion in 2021 and is projected to grow at a compounded annual growth rate (CAGR) of roughly 10% through 2028 (Research and Markets). Menotropins specifically account for a substantial share due to their widespread use in ovarian stimulation protocols and For individuals undergoing IVF, ICSI, or intrauterine insemination (IUI).

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Market Drivers

Rising Infertility Prevalence

Global infertility prevalence is estimated at around 8-12%, afflicting over 180 million individuals worldwide (WHO, 2021). Factors such as delayed childbearing, environmental toxins, endocrine disruptors, and lifestyle choices increase demand for ART solutions incorporating menotropins.

Advancements in ART Technologies

Innovations in IVF procedures, embryo cryopreservation, and ovarian stimulation cycles enhance treatment success rates. These technological progressions elevate the reliance on effective gonadotropin preparations, stabilizing demand for menotropins.

Increasing Adoption in Developing Markets

Emerging economies such as China, India, and Brazil are witnessing increased adoption of fertility treatments driven by rising awareness, improved healthcare infrastructure, and socioeconomic shifts favoring family planning. This expansion broadens the geographical market base for menotropins.

Regulatory Approvals and Expanded Indications

Continued clinical research supports broader indications for menotropins, encouraging regulatory approvals in new markets. Additionally, some biologics are being repositioned or reformulated as biosimilars, potentially reducing costs and increasing accessibility.

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Market Challenges and Restraints

High Cost and Limited Affordability

Menotropins are expensive due to their complex production processes and limited generic availability, constraining access in lower-income regions. High treatment costs can deter utilization, especially in markets without comprehensive insurance coverage.

Stringent Regulatory Environment

Manufacturing biologics like menotropins requires compliance with rigorous standards under agencies such as the US FDA and European EMA. These regulatory hurdles can lag product launches, constrain innovation, and inflate development costs.

Availability of Biosimilars and Alternatives

The entry of biosimilars presents both opportunities and challenges. While biosimilars have the potential to lower prices, current patent protections and clinical equivalence requirements can delay market entry and impact incumbent revenues.

Ethical and Cultural Factors

Treatment acceptance varies across cultures, influenced by societal attitudes toward infertility and assisted reproduction. These factors impact market penetration rates in specific regions.

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Financial Trajectory and Future Outlook

Revenue Growth Projections

Based on current market trends, the men's gonadotropins segment, primarily dominated by menotropins, is anticipated to grow at a CAGR of approximately 8-10% over the next five years. Factors supporting this include expanding global infertility treatment rates, technological advancements, and increased approval of biosimilars.

Pricing Strategies and Market Penetration

Manufacturers are adopting tiered pricing models to capitalize on emerging markets, balancing profitability with accessibility. Companies investing in biosimilar development aim to penetrate markets traditionally dominated by branded biologics, offering potentially 20-40% cost reductions.

Impact of Patent Expirations

Patent expirations for leading brands like Menopur and Pergonal (though these expired decades ago) have historically opened the door for biosimilar competition. Future patent expirations may further influence the market landscape, encouraging innovation but also intensifying price competition.

Emerging Market Growth

Projected rapid growth in Asia-Pacific, Latin America, and Africa is driven by increasing healthcare investment and demographic shifts. These markets could contribute 40-50% of global growth in menotropins sales during the forecast period.

Pipeline and Future Innovations

Research into more potent, fewer-dose formulations and oral alternatives remains limited due to the biological nature of the target hormones. Nevertheless, advancements in recombinant DNA technology may lead to more scalable and cost-effective production methods, simplifying supply chains and improving margins.

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Regulatory and Competitive Landscape

Regulatory agencies enforce rigorous standards for biologics, impacting time-to-market and pricing. Market players must navigate regional approval processes, often incurring high R&D and compliance costs.

Competitively, incumbent manufacturers hold significant advantages due to established brand recognition and supply chain networks. However, biosimilar entrants increasingly threaten to dilute market share and lower prices, especially in cost-sensitive regions.

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Strategic Implications and Investment Outlook

Companies focused on Asia-Pacific and Latin America should prioritize market expansion and local partnerships. Investment in biosimilar R&D can catalyze growth, given the global push toward cost-effective fertility treatments.

Furthermore, collaborations with research institutions to develop next-generation biologics could sustain long-term competitiveness amid evolving regulation and competition.

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Key Takeaways

• The menotropins market is poised for robust growth driven by increasing infertility rates, technological innovations, and expanding access in emerging economies.

• High manufacturing costs, regulatory hurdles, and biosimilar competition pose significant challenges but also opportunities for cost reduction and market penetration.

• Strategic focus on biosimilars, regional expansion, and innovative formulations will be vital for stakeholders aiming to capitalize on this trajectory.

• The evolving regulatory environment necessitates proactive compliance strategies to optimize time-to-market and profitability.

• Long-term growth hinges on balancing technological innovation with affordability, especially in developing nations.

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FAQs

1. What are menotropins, and how do they differ from other fertility drugs?
Menotropins are biologic preparations comprising FSH and LH derived from human menopausal urine or recombinant sources. They stimulate ovarian follicle development, contrasting with simpler agents like clomiphene citrate, which modulate hormonal pathways without directly replacing gonadotropins.

2. How does biosimilar competition influence the menotropins market?
Biosimilars offer cost-effective alternatives to branded menotropins, potentially eroding market share and driving prices downward. Their approval depends on demonstrating similarity in efficacy and safety, and their success depends on regulatory acceptance and physician confidence.

3. What are the key regulatory hurdles impacting menotropins commercialization?
Biologics face strict requirements for manufacturing consistency, pharmacovigilance, and clinical data. Regulatory agencies mandate rigorous proof of biosimilarity for biosimilars, lengthening approval timelines and increasing costs.

4. Which regions are expected to drive the most growth in menotropins demand?
Emerging markets in Asia-Pacific and Latin America are anticipated to lead growth, driven by improving reproductive health infrastructure, rising infertility awareness, and favorable socioeconomic changes.

5. How might future innovations impact the financial landscape of menotropins?
Advancements such as recombinant technologies reducing production costs, novel delivery methods, and potential oral formulations could lower prices and expand access, influencing overall revenue and market dynamics favorably.

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Sources:

[1] Research and Markets, "Global Fertility Drugs Market Forecast," 2022.
[2] WHO, Infertility Fact Sheet, 2021.
[3] Grand View Research, "Reproductive Health Market Analysis," 2022.