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Last Updated: July 19, 2025

TRELSTAR Drug Patent Profile


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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

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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
Drug patent expirations by year for TRELSTAR
Drug Prices for TRELSTAR

See drug prices for TRELSTAR

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TRELSTAR
Generic Entry Date for TRELSTAR*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Prostate Cancer FoundationPhase 2
Panbela TherapeuticsPhase 2
Bristol-Myers SquibbPhase 2

See all TRELSTAR clinical trials

US Patents and Regulatory Information for TRELSTAR

TRELSTAR is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRELSTAR is ⤷  Try for Free.

This potential generic entry date is based on patent ⤷  Try for Free.

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

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 ⤷  Try for Free ⤷  Try for Free
Verity TRELSTAR triptorelin pamoate INJECTABLE;INTRAMUSCULAR 021288-001 Jun 29, 2001 ⤷  Try for Free ⤷  Try for Free
Verity TRELSTAR triptorelin pamoate INJECTABLE;INTRAMUSCULAR 020715-001 Jun 15, 2000 ⤷  Try for Free ⤷  Try for Free
Verity TRELSTAR triptorelin pamoate INJECTABLE;INTRAMUSCULAR 021288-001 Jun 29, 2001 ⤷  Try for Free ⤷  Try for Free
Verity TRELSTAR triptorelin pamoate INJECTABLE;INTRAMUSCULAR 020715-001 Jun 15, 2000 ⤷  Try for Free ⤷  Try for Free
Verity TRELSTAR triptorelin pamoate INJECTABLE;INTRAMUSCULAR 020715-001 Jun 15, 2000 ⤷  Try for Free ⤷  Try for Free
Verity TRELSTAR triptorelin pamoate INJECTABLE;INTRAMUSCULAR 020715-001 Jun 15, 2000 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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)

Patent: 00
Patent: Slow release pharmaceutical composition made of microparticles
Estimated Expiration: ⤷  Try for Free

Australia

Patent: 08259411
Patent: Slow release pharmaceutical composition made of microparticles
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 0812250
Patent: COMPOSIÇÃO FARMACÊUTICA DE LIBERAÇÃO LENTA FEITA DE MICROPARTÍCULAS
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 88478
Patent: COMPOSITION PHARMACEUTIQUE A LIBERATION LENTE, FAITE DE MICROPARTICULES (SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES)
Estimated Expiration: ⤷  Try for Free

China

Patent: 1677959
Patent: Slow release pharmaceutical composition made of microparticles
Estimated Expiration: ⤷  Try for Free

Colombia

Patent: 51234
Patent: COMPOSICIONES QUE COMPRENDEN MICROPARTICULAS DE UN COPOLIMERO DE ACIDO LACTICO Y GLICOLICO (PLGA) CON UNA SUSTANCIA ACTIVA EN LA FORMA DE UNA SAL PEPTIDICA INSOLUBLE
Estimated Expiration: ⤷  Try for Free

Croatia

Patent: 0161785
Estimated Expiration: ⤷  Try for Free

Patent: 0181854
Estimated Expiration: ⤷  Try for Free

Cyprus

Patent: 18434
Estimated Expiration: ⤷  Try for Free

Patent: 20891
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 64467
Estimated Expiration: ⤷  Try for Free

Patent: 00014
Estimated Expiration: ⤷  Try for Free

Eurasian Patent Organization

Patent: 9284
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ С ПРОЛОНГИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, ПРИГОТОВЛЕННАЯ ИЗ МИКРОЧАСТИЦ (SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES)
Estimated Expiration: ⤷  Try for Free

Patent: 0971132
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ С ПРОЛОНГИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, ПРИГОТОВЛЕННАЯ ИЗ МИКРОЧАСТИЦ
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 64467
Patent: COMPOSITION PHARMACEUTIQUE À LIBÉRATION LENTE, FAITE DE MICROPARTICULES (SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES)
Estimated Expiration: ⤷  Try for Free

Patent: 00014
Patent: Composition pharmaceutique à libération lente, faite de microparticules (Slow release pharmaceutical composition made of microparticles)
Estimated Expiration: ⤷  Try for Free

Patent: 31077
Patent: COMPOSITION PHARMACEUTIQUE À LIBÉRATION LENTE FABRIQUÉE À PARTIR DE MICROPARTICULES (SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES)
Estimated Expiration: ⤷  Try for Free

Finland

Patent: 00014
Estimated Expiration: ⤷  Try for Free

Hong Kong

Patent: 41737
Patent: SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 31550
Estimated Expiration: ⤷  Try for Free

Patent: 40391
Estimated Expiration: ⤷  Try for Free

Israel

Patent: 2501
Patent: תכשירים המכילים מיקרו חלקיקים לשחרור מבוקר של טריפטולרין ושימוש בהם להכנת תרופה לטיפול בסרטן הערמונית (Pharmaceutical composition made of microparticles for controlled release of triptorelin and use thereof for the manufacture of a drug for the treatment of prostate cancer)
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 19169
Estimated Expiration: ⤷  Try for Free

Patent: 10529106
Estimated Expiration: ⤷  Try for Free

Lithuania

Patent: 64467
Estimated Expiration: ⤷  Try for Free

Patent: 00014
Estimated Expiration: ⤷  Try for Free

Malaysia

Patent: 0450
Patent: SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 09012856
Patent: COMPOSICION FARMACEUTICA DE LIBERACION LENTA HECHA DE MICROPARTICULAS. (SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES.)
Estimated Expiration: ⤷  Try for Free

Montenegro

Patent: 959
Patent: FARMACEUTSKA KOMPOZICIJA SA SPORIM OSLOBAĐANJEM KOJA JE FORMIRANA OD MIKROČESTICA (SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES)
Estimated Expiration: ⤷  Try for Free

Morocco

Patent: 422
Patent: COMPOSITION PHARMACEUTIQUE A LIBERATION PROLONGEE CONSTITUEE DE MICROPARTICULES
Estimated Expiration: ⤷  Try for Free

New Zealand

Patent: 2423
Patent: SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES COMPRISING PLGA, LHRH AND LACTIC ACID
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 64467
Estimated Expiration: ⤷  Try for Free

Patent: 00014
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 64467
Estimated Expiration: ⤷  Try for Free

Patent: 00014
Estimated Expiration: ⤷  Try for Free

Serbia

Patent: 591
Patent: FARMACEUTSKA KOMPOZICIJA SA SPORIM OSLOBAĐANJEM PRIPREMLJENA OD MIKROČESTICA (SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES)
Estimated Expiration: ⤷  Try for Free

Patent: 248
Patent: FARMACEUTSKA KOMPOZICIJA SA SPORIM OSLOBAĐANJEM PRIPREMLJENA OD MIKROČESTICA (SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES)
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 64467
Estimated Expiration: ⤷  Try for Free

Patent: 00014
Estimated Expiration: ⤷  Try for Free

South Africa

Patent: 0907940
Patent: Slow release pharmaceutical composition made of microparticles
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 1631475
Estimated Expiration: ⤷  Try for Free

Patent: 100023950
Patent: SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 11020
Estimated Expiration: ⤷  Try for Free

Patent: 94401
Estimated Expiration: ⤷  Try for Free

Tunisia

Patent: 09000476
Patent: SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES
Estimated Expiration: ⤷  Try for Free

Ukraine

Patent: 830
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ С ПРОЛОНГИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, ИЗГОТОВЛЕННАЯ ИЗ МИКРОЧАСТИЦ;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ З ПРОЛОНГОВАНИМ ВИВІЛЬНЕННЯМ, ВИГОТОВЛЕНА З МІКРОЧАСТИНОК (SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES)
Estimated Expiration: ⤷  Try for Free

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 ⤷  Try for Free
Denmark 518988 ⤷  Try for Free
South Africa 8806827 ⤷  Try for Free
Denmark 175495 ⤷  Try for Free
Japan H01121222 DRUG COMPOSITION FOR KEEPING AND REGULATING RELEASE OF DRUG OVER LONG TIME ⤷  Try for Free
Spain 2020890 PROCEDIMIENTO DE PREPARACION DE UNA COMPOSICION FARMACEUTICA EN FORMA DE MICROPARTICULAS. (METHOD FOR PREPARING A PHARMACEUTICAL COMPOSITION IN THE FORM OF MICROPARTICLES) ⤷  Try for Free
Croatia P20161785 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

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.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.