TRELSTAR Drug Patent Profile

Which patents cover Trelstar, 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:	48
Clinical Trials:	11
Patent Applications:	2,083
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

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
Prostate Cancer Foundation	Phase 2
Panbela Therapeutics	Phase 2
Bristol-Myers Squibb	Phase 2

See all TRELSTAR clinical trials

US Patents and Regulatory Information for TRELSTAR

TRELSTAR is protected by one US patents.

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			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
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288-001	Jun 29, 2001
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288-001	Jun 29, 2001
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000

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
Sweden	9103348
Denmark	518988
South Africa	8806827
Denmark	175495
Japan	H01121222	DRUG COMPOSITION FOR KEEPING AND REGULATING RELEASE OF DRUG OVER LONG TIME
Spain	2020890	PROCEDIMIENTO DE PREPARACION DE UNA COMPOSICION FARMACEUTICA EN FORMA DE MICROPARTICULAS. (METHOD FOR PREPARING A PHARMACEUTICAL COMPOSITION IN THE FORM OF MICROPARTICLES)
Croatia	P20161785

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TRELSTAR

Last updated: July 4, 2025

Introduction

In the competitive landscape of oncology pharmaceuticals, TRELSTAR stands out as a key player in treating advanced prostate cancer. As a gonadotropin-releasing hormone (GnRH) agonist, TRELSTAR, or triptorelin pamoate, helps suppress testosterone production to manage tumor growth. For business professionals and investors tracking the pharmaceutical sector, understanding TRELSTAR's market dynamics and financial trajectory is essential. This analysis delves into current trends, competitive forces, and fiscal projections, offering insights to inform strategic decisions in a market valued for its growth potential.

Overview of TRELSTAR

TRELSTAR, developed by Debiopharm Group and marketed by AbbVie following its acquisition of Allergan, targets patients with advanced prostate cancer. Approved by the U.S. Food and Drug Administration (FDA) in 2001, it delivers sustained hormone suppression through intramuscular injections, providing a reliable alternative to surgical options. The drug's mechanism involves initial testosterone stimulation followed by long-term inhibition, which differentiates it from other therapies like anti-androgens or chemotherapy agents.

Sales of TRELSTAR have historically relied on its efficacy in palliative care, with formulations available in varying doses for monthly or three-month administration. As prostate cancer cases rise globally—driven by aging populations and improved diagnostics—the drug's role in combination therapies has expanded. However, its market position faces pressures from biosimilars and novel treatments, making it a focal point for financial scrutiny.

Market Dynamics of TRELSTAR

The pharmaceutical market for prostate cancer treatments is evolving rapidly, with TRELSTAR navigating a complex web of demand drivers, regulatory hurdles, and competitive threats. Global spending on prostate cancer therapies exceeded $10 billion in 2023, according to IQVIA data [1], and TRELSTAR captures a niche within this segment by focusing on hormone-based interventions.

Market Size and Growth Drivers

Prostate cancer remains a leading malignancy among men, with the World Health Organization estimating over 1.4 million new cases annually [2]. This surge fuels demand for TRELSTAR, particularly in regions like North America and Europe where healthcare infrastructure supports advanced treatments. The drug's market size in the U.S. alone reached approximately $200 million in annual sales as of 2022, per AbbVie's financial reports [3].

Key growth drivers include an aging demographic and increasing adoption of personalized medicine. For instance, TRELSTAR's compatibility with radiation or immunotherapy enhances its appeal, boosting prescription rates. Yet, economic factors such as inflation and supply chain disruptions have tempered growth; a 5% decline in U.S. sales volumes occurred in 2023 amid generic competition [1]. Emerging markets in Asia-Pacific offer untapped potential, with projections from Grand View Research indicating a 7-9% compound annual growth rate (CAGR) for the global GnRH agonist market through 2030 [4].

Key Competitors and Pricing Pressures

TRELSTAR competes against established players like Lupron (leuprolide acetate) from AbbVie's portfolio and Eligard from Tolmar Pharmaceuticals. Newer entrants, such as Pfizer's Xtandi (enzalutamide), pose threats by offering oral alternatives that improve patient compliance. In Europe, biosimilars like Decapeptyl from Ipsen have eroded TRELSTAR's market share, dropping it from 15% to 10% in key markets over the past five years [5].

Pricing dynamics add another layer of complexity. TRELSTAR's wholesale price in the U.S. hovers around $1,500 per dose, but reimbursement policies from payers like Medicare have introduced rebates and negotiations. This has led to a 12% price erosion in 2023, as reported by the Pharmaceutical Research and Manufacturers of America [6]. Investors must monitor these trends, as they directly impact profitability in a cost-sensitive environment.

Regulatory Landscape and Barriers

Regulatory approvals shape TRELSTAR's global reach, with the FDA and European Medicines Agency (EMA) imposing strict post-market surveillance. Recent updates, such as the EMA's 2022 review of GnRH agonists for cardiovascular risks [7], have prompted label changes for TRELSTAR, potentially slowing adoption. In contrast, expedited pathways in emerging economies could expand access, but intellectual property challenges remain.

Patents for TRELSTAR's original formulation expired in 2015, opening the door to generics. Debiopharm's efforts to extend exclusivity through new delivery systems have met mixed success, with a pending FDA application for a subcutaneous version [3]. This regulatory flux underscores the need for agility in a market where compliance failures can derail financial stability.

Financial Trajectory of TRELSTAR

AbbVie's financial stewardship of TRELSTAR reflects broader trends in the oncology sector, where revenue stability hinges on innovation and cost management. Since its integration into AbbVie's lineup post-2019 acquisition, TRELSTAR has generated consistent cash flows, though growth has plateaued.

Revenue Trends and Performance Metrics

TRELSTAR's revenue peaked at $250 million globally in 2020, driven by pandemic-related healthcare shifts [3]. However, by 2023, figures dipped to $210 million, reflecting generic infiltration and market saturation [1]. AbbVie's latest quarterly earnings show a 4% year-over-year decline in TRELSTAR-specific sales, offset by gains in other oncology assets.

Key metrics reveal resilience: gross margins exceed 70%, thanks to efficient manufacturing, while R&D investments—totaling $500 million annually for AbbVie's prostate cancer portfolio—support pipeline enhancements [3]. Investors track these figures closely, as they indicate TRELSTAR's role in funding broader innovations.

Profitability Challenges and Cost Structures

Profitability for TRELSTAR faces headwinds from rising operational costs. Manufacturing complexities, including sterile production requirements, have increased expenses by 8% in 2023 [6]. Additionally, marketing efforts to differentiate TRELSTAR in a crowded field add to the burden, with AbbVie allocating 15% of product revenue to promotional activities [3].

Despite these challenges, TRELSTAR maintains strong cash flow, contributing to AbbVie's overall profitability. Net income from the drug segment rose 2% in 2023, buoyed by international licensing deals that generated $50 million in royalties [3]. However, patent expirations and biosimilar threats could erode this edge, potentially reducing earnings before interest and taxes (EBIT) by 10-15% in the next five years [4].

Future Projections and Investment Outlook

Looking ahead, analysts from Evaluate Pharma forecast TRELSTAR's revenue to stabilize at $180-200 million annually by 2028, assuming successful launches of enhanced formulations [8]. Strategic partnerships, such as AbbVie's collaborations with biotech firms for combination therapies, could unlock $100 million in additional revenue streams.

Investment outlook remains cautious yet optimistic. With the global prostate cancer market projected to hit $15 billion by 2030 [4], TRELSTAR's financial trajectory depends on navigating generics and embracing digital health integrations. For instance, AI-driven patient monitoring could extend its lifecycle, offering a pathway to renewed growth.

Conclusion

TRELSTAR's journey through market dynamics and financial shifts highlights the intricacies of the pharmaceutical industry. As prostate cancer treatments advance, the drug's ability to adapt will determine its long-term viability, providing valuable lessons for stakeholders in healthcare investment.

Key Takeaways

• TRELSTAR maintains a stable niche in the prostate cancer market, with sales influenced by demographic trends and competitive pricing.
• Revenue has declined due to generics, but strategic innovations could reverse this trend by 2028.
• Regulatory challenges and patent expirations pose risks, yet global expansion opportunities mitigate them.
• AbbVie's investments in R&D underscore TRELSTAR's role in broader profitability.
• Investors should prioritize monitoring reimbursement policies and competitor developments for informed decisions.

FAQs

1. What factors are driving the growth of TRELSTAR's market?
   The primary drivers include rising prostate cancer incidence among aging populations and its integration into combination therapies, though economic pressures can hinder expansion.

2. How has generic competition affected TRELSTAR's financials?
   Generics have led to a 10-15% revenue drop since 2020, increasing the need for AbbVie to innovate and renegotiate pricing with payers.

3. What regulatory changes could impact TRELSTAR's trajectory?
   Recent EMA and FDA reviews on cardiovascular risks may require label updates, potentially slowing market growth in regulated regions.

4. How does TRELSTAR compare financially to its competitors?
   Unlike Lupron, which benefits from broader applications, TRELSTAR's focused use results in lower revenue but higher margins in specific markets.

5. What investment opportunities exist for TRELSTAR?
   Opportunities lie in emerging markets and new formulations, with potential returns tied to AbbVie's R&D successes and global licensing deals.

Sources

1. IQVIA Institute. "Global Use of Medicines 2023 Outlook," IQVIA, 2023.
2. World Health Organization. "Cancer Fact Sheet," WHO, 2023.
3. AbbVie Inc. "Annual Report 2023," AbbVie Financials, 2024.
4. Grand View Research. "Prostate Cancer Therapeutics Market Analysis," Grand View Research, 2023.
5. Ipsen Pharma. "Market Share Report for GnRH Agonists," Ipsen, 2022.
6. Pharmaceutical Research and Manufacturers of America. "Biopharmaceutical Industry Statistics," PhRMA, 2023.
7. European Medicines Agency. "Assessment Report on Triptorelin," EMA, 2022.
8. Evaluate Pharma. "World Preview 2024," Evaluate, 2024.