Leuprolide mesylate - Generic Drug Details

What are the generic sources for leuprolide mesylate and what is the scope of freedom to operate?

Leuprolide mesylate is the generic ingredient in two branded drugs marketed by Foresee Pharms and Accord, and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Leuprolide mesylate has thirty-nine patent family members in nineteen countries.

There is one drug master file entry for leuprolide mesylate. One supplier is listed for this compound.

Summary for leuprolide mesylate

International Patents:	39
US Patents:	5
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	6
DailyMed Link:	leuprolide mesylate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for leuprolide mesylate

Dosage:

EMULSION;SUBCUTANEOUS

Constraining patent/regulatory exclusivity:

NEW STRENGTH

Dosage:

EMULSION;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for leuprolide mesylate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
QPS	Phase 3
GeneScience Pharmaceuticals Co., Ltd.	Phase 3
Changchun GeneScience Pharmaceutical Co., Ltd.	PHASE3

See all leuprolide mesylate clinical trials

Pharmacology for leuprolide mesylate

Drug Class	Gonadotropin Releasing Hormone Receptor Agonist
Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

US Patents and Regulatory Information for leuprolide mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord	CAMCEVI KIT	leuprolide mesylate	EMULSION;SUBCUTANEOUS	211488-001	May 25, 2021		RX	Yes	Yes			Y
Accord	CAMCEVI KIT	leuprolide mesylate	EMULSION;SUBCUTANEOUS	211488-001	May 25, 2021		RX	Yes	Yes			Y
Accord	CAMCEVI KIT	leuprolide mesylate	EMULSION;SUBCUTANEOUS	211488-001	May 25, 2021		RX	Yes	Yes			Y

International Patents for leuprolide mesylate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019125358
Russian Federation	2427383	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ С ПОВЫШЕННОЙ СТАБИЛЬНОСТЬЮ (HIGH STABILITY PHARMACEUTICAL COMPOSITIONS)
China	101400363

Market Dynamics and Financial Trajectory for Leuprolide Mesylate

Last updated: July 28, 2025

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Introduction

Leuprolide mesylate, a luteinizing hormone-releasing hormone (LHRH) agonist, plays a pivotal role in managing hormone-sensitive conditions such as prostate cancer, breast cancer, endometriosis, and central precocious puberty. Market dynamics surrounding this drug hinge on factors including medical innovation, regulatory patterns, competitive landscape, manufacturing capacities, and evolving patient needs. Understanding these variables, alongside the financial trajectory of leuprolide mesylate, is essential for stakeholders engaging in formulation, marketing, and investment decisions.

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Market Overview and Key Drivers

Demand-Side Factors

Leuprolide mesylate's usage remains robust primarily due to the prevalence of its targeted conditions. Notably:

• Prostate Cancer: As the second most common cancer among men globally, prostate cancer accounts for a significant share of leuprolide's utilization (WHO, 2021). The aging population further sustains high demand growth.
• Endometriosis & Uterine Fibroids: Increasing diagnosis rates and improved awareness are propelling prescriptions in gynecological conditions.
• Prepubertal Central Precocious Puberty: Rising detection rates of early puberty suggest expanding indications.

Supply-Side Elements

Manufacturing capabilities, patent landscapes, and strategic alliances influence market supply:

• Generic Entry and Patent Expiry: Several formulations of leuprolide, including leuprolide acetate, have faced patent expirations, encouraging the proliferation of generics. These generics significantly lower treatment costs and potentially widen market penetration.
• Manufacturing Capacity Expansion: Major pharmaceutical firms, such as Ferring Pharmaceuticals and Sun Pharmaceutical, have ramped up production to meet global demand, mitigating potential shortages.

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Regulatory Environment & Impact on Market Dynamics

Regulatory agencies like the FDA and EMA have periodically evaluated leuprolide's safety and efficacy, leading to approvals, label modifications, and some market withdrawals. Any regulatory changes, especially concerning side-effect profiles or manufacturing standards, directly influence market stability and brand trust.

Emerging biosimilars, pending regulatory approval, threaten to erode market share held by branded formulations. Conversely, patient access programs and expanded indications may bolster protections against commoditization.

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Competitive Landscape

Brand vs. Generic Competition

• Branded Drugs: Lupron® (AbbVie/AbbVie Biotech) remains a flagship brand, commanding significant market share due to its established reputation and extensive clinical history.

• Generic Formulations: The entrance of bioequivalent generics, such as Teva’s and Sandoz’s versions, has driven prices downward, compelling branded manufacturers to reevaluate pricing strategies.

Innovative Alternatives

Emerging treatments, including oral GnRH antagonists, threaten to disrupt traditional leuprolide therapy by offering improved convenience and potentially fewer side effects. Such innovations may influence the long-term financial trajectory.

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Market Trends and Future Outlook

Market Growth Projections

Market research estimates suggest that the global leuprolide market, encompassing all formulations, exceeded USD 1.2 billion in 2022, with a compound annual growth rate (CAGR) of approximately 4-6% expected over the next five years (GlobalData, 2023). Factors contributing to this growth include:

• Growing elderly population elevating prostate cancer incidence.
• Increased adoption of long-acting injectable formulations.
• Geographical expansion into emerging markets with rising healthcare infrastructure.

Impact of Biosimilars and Emerging Therapies

The launch of biosimilar leuprolide products is anticipated to intensify price competition, reducing revenue streams for innovator companies. However, differentiated delivery systems, such as depot formulations, may preserve some profitability.

Additionally, gene therapies and non-hormonal treatment options may influence long-term demand, necessitating strategic diversification for stakeholders.

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Financial Trajectory Analysis

Revenue Streams

• Branded vs. Generic Sales: The initial phase of patent exclusivity yielded high margins for brand manufacturers. Post-patent expiry, generics have dominated, squeezing profit margins but expanding volume sales.
• Pricing Dynamics: The price erosion caused by generics varies by region but generally ranges from 20-50%. High-volume markets such as the US and Europe experience significant pressure to reduce prices.

Cost Structure and Margins

Manufacturing costs have decreased due to process improvements and scale benefits, with margins compressing as pricing diminishes. Innovator companies rely on value-added services, formulation advantages, and brand loyalty to sustain profitability.

Profitability and Investment Trends

Large pharmaceutical firms are increasingly investing in biosimilar development. The shift toward biosimilars and oral treatments suggests a future where leuprolide’s profitability landscape may plateau or decline unless new formulations or indications emerge.

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Legal & Patent Developments

Patent filings and litigations remain core to the financial outlook:

• Patent Litigation: Patent challenges, such as those seen with the original Lupron formulation, influence market exclusivity periods.
• Patent Extension Strategies: Lifecycle management tactics, including formulation innovations and additional indications, are employed to extend market monopoly.

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Conclusion and Industry Outlook

Leuprolide mesylate's market remains vital in endocrine and oncology therapies, with growth primarily driven by demographic trends and expanding indications. However, increasing generic penetration, biosimilar competition, and emerging treatment horizons impose downward pressure on prices and margins.

Pharmaceutical companies focusing on strategic innovation, geographical expansion, and lifecycle management are positioned for sustained financial performance. Conversely, industry stakeholders must monitor regulatory shifts and technological advancements to adapt pricing, manufacturing, and marketing strategies effectively.

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Key Takeaways

• Market consolidation driven by patent expirations favors generics, pressuring margins but increasing volume sales.
• Demographic trends, notably aging populations, underpin sustained demand, especially in prostate cancer treatments.
• Competitive innovations, including biosimilars and oral therapies, threaten traditional leuprolide formulations.
• Pricing strategies must balance regulatory price controls and market share retention, particularly in emerging markets.
• Investment in biosimilars and formulation improvements represent strategic avenues for companies aiming to extend product lifecycle profitability.

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FAQs

1. What factors most significantly influence leuprolide mesylate’s market growth?
   Demographic trends, especially age-related disease prevalence, technological innovations, regulatory policies, and competitive entry of biosimilars.

2. How does patent expiration impact the profitability of leuprolide formulations?
   Patent expiration opens the market to generic manufacturers, leading to price reductions and increased sales volume but reduced profit margins for brand-name producers.

3. Are biosimilars expected to replace branded leuprolide products?
   Biosimilars are projected to capture substantial market share, especially in cost-sensitive regions, potentially reducing reliance on branded formulations.

4. What emerging therapies could disrupt the leuprolide market?
   Oral GnRH antagonists, gene therapies, and other non-hormonal modalities may challenge leuprolide’s dominance as they offer improved convenience and safety profiles.

5. What strategies can pharmaceutical companies adopt to sustain profitability for leuprolide-based drugs?
   Investing in formulation innovations, expanding indications, strategic licensing, and geographical market penetration are key strategies to adapt to evolving market conditions.

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References

[1] World Health Organization. (2021). Cancer Fact Sheet.
[2] GlobalData. (2023). Leuprolide Market Analysis Report.