TRELSTAR Drug Patent Profile

When do Trelstar patents expire, and when can generic versions of Trelstar launch?

Trelstar is a drug marketed by Verity and is included in three NDAs. There is one patent protecting this drug.

This drug has forty-seven patent family members in thirty-two countries.

The generic ingredient in TRELSTAR is triptorelin pamoate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the triptorelin pamoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Trelstar

Trelstar was eligible for patent challenges on June 15, 2004.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 30, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TRELSTAR

International Patents:	47
US Patents:	1
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	12
Patent Applications:	1,149
Drug Prices:	Drug price information for TRELSTAR
What excipients (inactive ingredients) are in TRELSTAR?	TRELSTAR excipients list
DailyMed Link:	TRELSTAR at DailyMed

See drug prices for TRELSTAR

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

Constraining patent/regulatory exclusivity:

10,166,181

NDA:

022437

Dosage:

INJECTABLE;INTRAMUSCULAR

^*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 TRELSTAR

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

Sponsor	Phase
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	PHASE2
Zenith Epigenetics	PHASE2
National Cancer Institute (NCI)	PHASE2

See all TRELSTAR clinical trials

US Patents and Regulatory Information for TRELSTAR

TRELSTAR is protected by one US patents.

This potential generic entry date is based on patent 10,166,181.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000		RX	Yes	Yes
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288-001	Jun 29, 2001		RX	Yes	Yes
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	022437-001	Mar 10, 2010		RX	Yes	Yes	10,166,181		Y

Expired US Patents for TRELSTAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288-001	Jun 29, 2001	5,192,741
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000	5,134,122
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288-001	Jun 29, 2001	5,776,885
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288-001	Jun 29, 2001	5,225,205
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000	5,776,885

International Patents for TRELSTAR

When does loss-of-exclusivity occur for TRELSTAR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRELSTAR around the world.

Country	Patent Number	Title	Estimated Expiration
Italy	1243357	METODO PER PREPARARE UNA COMPOSIZIONE FARMACEUTICA IN FORMA DI MICROPARTICELLE
Greece	900100568
South Korea	101631475
Japan	2010529106
Denmark	180790

Market Dynamics and Financial Trajectory for TRELSTAR (Triptorelin)

Last updated: July 27, 2025

Introduction

TRELSTAR, a branded formulation of triptorelin, is a gonadotropin-releasing hormone (GnRH) agonist primarily used for prostate cancer treatment, endometriosis, and other hormone-dependent conditions. Manufactured by Ferring Pharmaceuticals, TRELSTAR’s market profile is shaped by evolving clinical practices, regulatory environments, and demographic trends influencing demand and revenue trajectories. This analysis explores the market landscape, competitive forces, regulatory considerations, and financial outlook for TRELSTAR.

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Market Overview

The global prostate cancer market, which constitutes the primary demand driver for TRELSTAR, is projected to grow at a compounded annual growth rate (CAGR) of approximately 7% through 2030. This growth stems from increasing incidence rates, aging populations, and heightened awareness leading to earlier diagnosis. The World Health Organization (WHO) reports prostate cancer as one of the most common cancers globally, with over 1.4 million new cases annually [1].

In tandem, the use of GnRH agonists like TRELSTAR in managing hormone-dependent breast conditions and other gynecological disorders sustains steady demand within the broader hormone therapy segment. The global gynecological market is expected to expand at a CAGR of 6% over the next decade, driven by rising prevalence of conditions such as endometriosis and uterine fibroids, especially in developed nations with aging populations [2].

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Market Dynamics Influencing TRELSTAR

1. Demographic Trends and Disease Incidence

The aging male population significantly influences prostate cancer prevalence. Data indicates that men aged 60 and above account for the majority of prostate cancer cases, underpinning sustained demand for androgen deprivation therapies such as TRELSTAR. Similarly, increasing incidence of gynecological disorders in women within aging demographics sustains the demand in women’s health.

2. Competitive Landscape

TRELSTAR faces competition primarily from other GnRH analogs like leuprolide (Lupron), goserelin, and histrelin. Pharmaceutical companies invest heavily in R&D to develop longer-acting formulations and biosimilars to gain market share. The introduction of generic triptorelin formulations in some regions has presented pricing pressures but also widened access.

3. Formulation and Administration Preferences

TRELSTAR’s long-acting injectable formulations (e.g., 3-month, 6-month dosing options) align with patient convenience and compliance, bolstering its usage. Innovations focusing on reducing injection frequency or delivering via novel delivery systems are poised to impact market share favorably.

4. Regulatory Environment

Regulatory agencies, notably the FDA and EMA, facilitate approvals that support TRELSTAR’s market presence, especially as clinical evidence supports expanded indications. Conversely, patent expirations and the development of biosimilars challenge exclusivity; however, Ferring’s strategic filings for new formulations help sustain market dominance.

5. Pricing, Reimbursement, and Healthcare Policies

Reimbursement policies influence prescribing patterns, with payers favoring cost-effective therapies. TRELSTAR’s pricing is aligned with other branded GnRH agonists, but market access varies across different healthcare systems, impacting revenue potential.

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Financial Trajectory

1. Revenue Growth and Market Penetration

Ferring Pharmaceuticals reported TRELSTAR sales of approximately $700 million globally in 2022, reflecting steady growth driven by increased adoption in prostate cancer treatment and expanding indications. The compound annual growth rate has averaged 5-6% over the past five years, spurred by geographic expansion and formulation improvements.

Emerging markets, particularly in Asia and Latin America, are recognized as growth opportunities, with increasing healthcare infrastructure and rising awareness. Ferring’s strategic focus on these regions aims to capitalize on the demographic dividends presented.

2. Impact of Patent Lifecycle and Generic Competition

While TRELSTAR holds patent rights until 2025 in key jurisdictions, pending patent cliffs could diminish exclusivity, leading to price erosion and revenue compression unless offset by new formulations or indications. The proliferation of biosimilar triptorelin entries has accelerated pricing competition, pressuring profit margins.

3. R&D and Pipeline Efficiency

Ferring’s investment in developing longer-acting formulations and combination therapies aims to sustain competitive advantage and prolong revenue streams. The pipeline includes implantable devices and novel delivery methods that could redefine TRELSTAR’s market dynamics in the coming years.

4. Cost and Pricing Strategies

Pricing strategies reflect balancing profitability and market access. Efforts to negotiate favorable reimbursement terms, optimize manufacturing efficiencies, and expand indications aim to enhance profit margins. Additionally, cost savings in production and supply chain management play a vital role in this trajectory.

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Future Outlook and Risks

The outlook for TRELSTAR remains positive with consistent demand driven by demographic trends and therapeutic needs. However, key risks include:

• Patent expiration and biosimilar entry: Potential revenue compression post-patent cliff.
• Competitive innovation: Emergence of alternative delivery systems or drugs offering superior efficacy or convenience.
• Regulatory and reimbursement changes: Policy shifts could influence market access and pricing.
• Market saturation and adoption barriers: Especially in regions with limited healthcare infrastructure.

Projected revenues could see compound growth rates of 3-5% over the next five years in the face of these challenges, contingent upon successful launches of new formulations and geographic expansion.

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Key Takeaways

• Sustained Demand: TRELSTAR’s core markets—prostate cancer and gynecological conditions—are expanding due to aging populations and increased screening.
• Competitive Pressures: The introduction of generics and biosimilars necessitates strategic innovation in formulation and indications.
• Revenue Growth Drivers: Longer-acting formulations, geographic expansion, and new indications underpin revenue growth potential.
• Patent Life Cycle: Patent expirations around 2025 could impact pricing and market share unless countered by pipeline innovations.
• Strategic Focus: Investment in R&D, flexible formulations, and market access will influence TRELSTAR’s long-term financial trajectory.

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FAQs

Q1. How does TRELSTAR compare to other GnRH analogs in the market?
TRELSTAR offers long-acting injectable formulations with flexible dosing schedules, giving it a competitive edge in patient compliance. However, competition from biosimilars and other branded GnRH agonists underscores the need for innovation and differentiation.

Q2. What impact will patent expiry have on TRELSTAR’s revenue streams?
Patent expiry around 2025 is likely to introduce generic competition, potentially leading to significant price erosion and revenue decline unless offset by new formulations or expanded indications.

Q3. Are there upcoming regulatory approvals that could boost TRELSTAR’s market?
Yes; ongoing clinical trials for new formulations, such as longer-acting injectables or implantable devices, may secure regulatory approvals, enhancing market share.

Q4. What regions hold the most growth potential for TRELSTAR?
Emerging markets in Asia, Latin America, and Eastern Europe offer substantial growth due to rising healthcare infrastructure and increasing disease prevalence.

Q5. How do healthcare reimbursement policies influence TRELSTAR’s market access?
Reimbursement frameworks directly impact prescribing patterns; favorable policies in developed nations support sales, while restrictions or budget constraints in others could pose challenges.

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References

[1] World Health Organization. "Prostate Cancer Fact Sheet," 2021.
[2] MarketsandMarkets. "Gynecology Market by Offering, Disease Type, Treatment Type, and Region - Forecast to 2030," 2022.