ELIGARD KIT Drug Patent Profile

When do Eligard Kit patents expire, and what generic alternatives are available?

Eligard Kit is a drug marketed by Tolmar and is included in four NDAs. There are three patents protecting this drug.

This drug has twenty-eight patent family members in twenty-five countries.

The generic ingredient in ELIGARD KIT is leuprolide acetate. There are twenty-two drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Eligard Kit

A generic version of ELIGARD KIT was approved as leuprolide acetate by SANDOZ on August 4^th, 1998.

Summary for ELIGARD KIT

International Patents:	28
US Patents:	3
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	2
Clinical Trials:	55
DailyMed Link:	ELIGARD KIT at DailyMed

Recent Clinical Trials for ELIGARD KIT

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

Sponsor	Phase
TOLMAR PHARMACEUTIQUES CANADA, INC.	PHASE2
Ontario Clinical Oncology Group (OCOG) - McMaster University	PHASE2
Ontario Clinical Oncology Group (OCOG)	PHASE2

See all ELIGARD KIT clinical trials

Pharmacology for ELIGARD KIT

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

US Patents and Regulatory Information for ELIGARD KIT

ELIGARD KIT is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021343-001	Jan 23, 2002		RX	Yes	Yes	12,397,120
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021488-001	Feb 13, 2003		RX	Yes	Yes	12,397,120
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021379-001	Jul 24, 2002		RX	Yes	Yes	12,397,120
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021731-001	Dec 14, 2004		RX	Yes	Yes	11,771,841		Y	Y
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021488-001	Feb 13, 2003		RX	Yes	Yes	11,771,841		Y	Y
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021343-001	Jan 23, 2002		RX	Yes	Yes	11,931,559			Y

Expired US Patents for ELIGARD KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021488-001	Feb 13, 2003	9,539,333
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021379-001	Jul 24, 2002	6,626,870
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021488-001	Feb 13, 2003	6,626,870
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021379-001	Jul 24, 2002	6,565,874
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021379-001	Jul 24, 2002	6,773,714
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021379-001	Jul 24, 2002	9,283,282

International Patents for ELIGARD KIT

See the table below for patents covering ELIGARD KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H04503163
Lithuania	4135830
Germany	68929441
Canada	2348016	COMPOSITIONS DE DISTRIBUTION LIQUIDES A LIBERATION CONTROLEEAVEC FAIBLE DECHARGE INITIALE DE MEDICAMENT (CONTROLLED RELEASE LIQUID DELIVERY COMPOSITIONS WITH LOW INITIAL DRUG BURST)
European Patent Office	1586309	Forme d'administration polymerique de leuprolide avec efficacité amelioré (Polymeric delivery formulations of leuprolide with improved efficacy)
Australia	6071890

Supplementary Protection Certificates for ELIGARD KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0436667	91193	Luxembourg		91193, EXPIRES: 20140927
0436667	C300204	Netherlands

Market Dynamics and Financial Trajectory for ELIGARD KIT

Last updated: July 27, 2025

Introduction

ELIGARD KIT, a long-acting gonadotropin-releasing hormone (GnRH) agonist, is primarily prescribed for prostate cancer management and other hormone-dependent conditions. Its market presence is influenced by a complex interplay of clinical efficacy, competitive landscape, regulatory policies, and broader healthcare trends. Analyzing the current market dynamics and forecasting financial trajectories provides valuable insights for stakeholders including pharmaceutical companies, investors, and healthcare providers.

Overview of ELIGARD KIT

ELIGARD KIT, marketed by Sofgen (a generic equivalent of the original Leuprolide acetate formulations), is a sustained-release depot formulation of leuprolide, designed to reduce treatment frequency and improve patient compliance. It is administered via intramuscular injection, generally on a monthly or quarterly basis, depending on the specific formulation.

The drug is indicated predominantly for advanced prostate cancer, BPH, endometriosis, and uterine fibroids. Its commercialization hinges on patent protections, regulatory approvals, and adherence to evolving clinical guidelines.

Market Dynamics

1. Epidemiological Drivers

The prevalence of prostate cancer remains a critical driver. With over 1.4 million new cases globally in 2020, and prostate cancer accounting for approximately 15% of male cancers worldwide, the demand for androgen deprivation therapies (ADTs), including ELIGARD, continues to grow (source: Globocan 2020). An aging global population further amplifies this trend, as prostate cancer predominantly affects men over 65.

2. Competitive Landscape

ELIGARD faces competition from multiple formulations of GnRH agonists, such as Lupron (AbbVie), Zoladex (Ferring), and firm’s generic equivalents. The competitive dynamics are shaped by:

• Pricing strategies: Generics and biosimilars have heightened price competition, pressuring margins.
• Formulation preferences: Longer-acting formulations reduce dosing frequency, appealing to adherence and quality of life.
• Innovation: The advent of GnRH antagonists (e.g., degarelix) offering rapid testosterone suppression with fewer side effects pose a competitive threat.

3. Regulatory and Reimbursement Policies

Regulatory agencies such as the FDA and EMA influence market access through approval standards. Reimbursement policies determine patient access; countries with widespread insurance coverage for oncology drugs enhance sales potential.

In some markets, health economic evaluations favor long-acting formulations like ELIGARD due to reduced administration costs and improved adherence, encouraging payers to favor these options.

4. Clinical Guidelines and Treatment Patterns

Guidelines issued by organizations such as NCCN and ESMO influence prescribing behaviors. The integration of ELIGARD into standard-of-care protocols for prostate cancer sustains its demand. Trends toward earlier diagnosis and extended survival rates necessitate prolonged therapy durations, positively impacting sales.

5. Manufacturing and Supply Chain Considerations

Supply chain reliability impacts product availability. The shift toward biosimilar and generic formulations demands efficient manufacturing to maintain margins amid price pressures.

Financial Trajectory Analysis

1. Revenue Trends

The global prostate cancer market was valued at approximately USD 8 billion in 2021 and is projected to grow at a CAGR of around 6% through 2027 [2]. ELIGARD’s market share is closely tied to the prevalence of prostate cancer, with a significant proportion of patients on GnRH agonist therapy.

In mature markets such as the U.S. and Europe, key revenue streams derive from established regulatory approvals and reimbursement coverage. Emerging markets, including parts of Asia and Latin America, present growth opportunities due to increasing healthcare infrastructure and prostate cancer awareness.

2. Impact of Patent Expiration and Generics

Patent expirations typically occur 10-12 years post-approval, encouraging entries from generic manufacturers. The entry of generics has led to price erosion, diminishing per-unit revenue but expanding overall market volume. For ELIGARD, which was initially protected by patents, the arrival of biosimilars may considerably alter financial trajectories over the medium term.

3. Pricing Dynamics

Pricing strategies are vital; long-acting formulations tend to command premium pricing due to their convenience. However, competitive pressures from generics and biosimilars drive prices downward, challenging profitability.

4. Market Penetration and Expansion Strategies

Expansion into new geographies via localized regulatory approval and strategic partnerships enhances revenues. Similarly, developing combination therapies or securing broader indications fosters revenue diversification.

5. Forecasting Future Sales

Considering the current market expansion, patent cliffs, and emerging competitors, a conservative projection suggests:

• Short-term (1–3 years): Stable growth driven by existing patient base, with slight price pressure.
• Medium term (3–7 years): Revenue decline anticipated due to patent expiry and generic competition.
• Long term (>7 years): Market consolidation, potential shift to biosimilars or alternative therapies, possibly leading to reduced revenues unless new indications or formulations are developed.

Key Market Opportunities and Challenges

Opportunities

• Expansion into emerging markets with increasing prostate cancer incidence.
• Product development involving extended-release formulations or combination therapies.
• Strategic partnerships with healthcare providers for improved market penetration.
• Clinical trial advancements supporting broader indications or improved efficacy.

Challenges

• Pricing pressures stemming from generic proliferation.
• Competitive dynamics favoring alternative therapies such as GnRH antagonists.
• Regulatory hurdles in non-established markets.
• Patient preference shifting towards oral therapies or newer modalities.

Conclusion

ELIGARD KIT's market outlook hinges on a nuanced understanding of demographic trends, competitive pressures, and regulatory environments. While current revenues are supported by established clinical protocols and broadening prostate cancer diagnosis, impending patent expirations and intensifying competition pose significant threats. Strategic diversification into emerging markets and innovation in formulation or indication expansion will be key to maintaining financial stability.

Key Takeaways

• The global increase in prostate cancer prevalence sustains demand for long-acting GnRH agonists like ELIGARD, underpinning its market strength.
• Competitive pressures from biosimilars, generics, and alternative therapies threaten revenue streams, necessitating innovation and strategic positioning.
• Regulatory and reimbursement policies significantly influence market access, with long-acting formulations favored where cost-effectiveness is demonstrated.
• Market expansion into emerging economies offers growth potential, contingent on navigating regulatory and infrastructural barriers.
• Future financial success depends on product lifecycle management, including patent strategies, pipeline development, and potential label extensions.

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FAQs About ELIGARD KIT Market Dynamics and Financial Trajectory

Q1: How does patent expiration impact ELIGARD KIT’s market revenue?

A: Patent expiry typically leads to increased generic competition, resulting in price erosion and reduced per-unit revenue. However, overall market volume may compensate partially, depending on brand loyalty and geographic expansion.

Q2: What competitive therapies threaten ELIGARD’s market share?

A: GnRH antagonists such as degarelix and oral androgen deprivation agents are competing options, often offering faster testosterone suppression and fewer side effects.

Q3: Which regions offer the most growth potential for ELIGARD?

A: Emerging markets in Asia, Latin America, and Eastern Europe present significant growth opportunities due to rising disease awareness and improving healthcare infrastructure.

Q4: How does the prevalence of prostate cancer influence ELIGARD’s sales?

A: Higher prostate cancer prevalence directly correlates with increased demand for hormonal therapies like ELIGARD, especially in aging populations.

Q5: What strategic actions can pharmaceutical companies take to prolong the product’s profitability?

A: Companies can pursue formulation innovations, seek new indications, expand clinical evidence, and establish partnerships to bolster market access and defend against generic competition.

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Sources:

[1] Globocan 2020 Cancer Statistics. International Agency for Research on Cancer.
[2] Grand View Research. Prostate Cancer Market Size, Share & Trends Analysis Report.