Triptorelin pamoate - Generic Drug Details

What are the generic drug sources for triptorelin pamoate and what is the scope of freedom to operate?

Triptorelin pamoate is the generic ingredient in two branded drugs marketed by Azurity and Verity, and is included in four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Triptorelin pamoate has forty-seven patent family members in thirty-two countries.

There are two drug master file entries for triptorelin pamoate. Three suppliers are listed for this compound.

Summary for triptorelin pamoate

International Patents:	47
US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	4
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	19
What excipients (inactive ingredients) are in triptorelin pamoate?	triptorelin pamoate excipients list
DailyMed Link:	triptorelin pamoate at DailyMed

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

Constraining patent/regulatory exclusivity:

10,166,181

Dosage:

FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

Constraining patent/regulatory exclusivity:

10,166,181

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 triptorelin pamoate

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

Sponsor	Phase
Children's Oncology Group	PHASE3
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	PHASE4
Janssen Pharmaceutica	Phase 2

See all triptorelin pamoate clinical trials

Medical Subject Heading (MeSH) Categories for triptorelin pamoate

Antineoplastic Agents, Hormonal

Luteolytic Agents

Anatomical Therapeutic Chemical (ATC) Classes for triptorelin pamoate

L02AE	Gonadotropin releasing hormone analogues
L02A	HORMONES AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for triptorelin pamoate

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
Azurity	TRIPTODUR KIT	triptorelin pamoate	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	208956-001	Jun 29, 2017		RX	Yes	Yes	10,166,181		Y
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	022437-001	Mar 10, 2010		RX	Yes	Yes	10,166,181		Y

Expired US Patents for triptorelin pamoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288-001	Jun 29, 2001	5,776,885
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	020715-001	Jun 15, 2000	5,134,122
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	022437-001	Mar 10, 2010	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
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	021288-001	Jun 29, 2001	5,192,741

International Patents for triptorelin pamoate

Country	Patent Number	Title	Estimated Expiration
Portugal	2164467
Malaysia	150450	SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES
Slovenia	2164467
Hungary	E031550
Australia	2008259411	Slow release pharmaceutical composition made of microparticles
Montenegro	00959	FARMACEUTSKA KOMPOZICIJA SA SPORIM OSLOBAĐANJEM KOJA JE FORMIRANA OD MIKROČESTICA (SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Triptorelin Pamoate

Last updated: July 27, 2025

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Introduction

Triptorelin pamoate, a long-acting gonadotropin-releasing hormone (GnRH) agonist, is primarily used for the treatment of hormone-dependent cancers such as prostate cancer, endometriosis, and in some cases, central precocious puberty. Approved by regulatory agencies like the FDA and EMA, its therapeutic efficacy and extended dosing intervals have positioned it as a cornerstone in hormonal therapy. As the pharmaceutical landscape evolves, understanding the market dynamics and financial trajectory of triptorelin pamoate provides valuable insights for stakeholders ranging from pharmaceutical companies to healthcare providers and investors.

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Market Overview and Demand Drivers

1. Therapeutic Indications and Market Penetration

Triptorelin pamoate's principal indications include advanced prostate cancer, endometriosis, and central precocious puberty. The escalating prevalence of these conditions, especially in aging populations and women of reproductive age, underpins the sustained demand.

• Prostate Cancer: As the most common cancer among men globally, with an estimated 1.4 million new cases annually (World Health Organization, 2020), prostate cancer treatment remains a key growth driver. GnRH agonists like triptorelin pamoate are frontline therapies, contributing significantly to its sales [1].

• Endometriosis: Affecting approximately 10% of women of reproductive age worldwide, endometriosis treatment needs—particularly those requiring hormonal suppression—facilitate steady demand for triptorelin pamoate [2].

• Precocious Puberty: Cases of central precocious puberty are increasing, especially due to improved diagnosis and awareness, expanding the therapeutic scope.

2. Competitive Landscape

Triptorelin pamoate faces competition from other GnRH analogs such as leuprolide, goserelin, and histrelin. Patent expirations in some markets have prompted generic entry, intensifying price competition and affecting revenue streams. However, its long-acting formulations, like 3, 4, and 6-month depot injections, confer a competitive edge through improved patient compliance.

3. Market Penetration and Geographic Trends

The North American and European markets dominate due to widespread adoption, established reimbursement pathways, and high healthcare expenditure. Emerging markets in Asia-Pacific, Latin America, and the Middle East are witnessing accelerated adoption, driven by increasing healthcare infrastructure and awareness.

• Asia-Pacific: Projected CAGR of approximately 6.5%, reflecting expanding healthcare access and aging demographics [3].

• North America: Mature but projected to sustain growth owing to ongoing prostate cancer management needs and expanding indications.

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Market Dynamics Influencing Financial Trajectory

1. Pricing and Reimbursement Policies

Reimbursement frameworks critically influence revenue. The introduction of generics has pushed prices downward, especially in countries with aggressive price negotiation policies like the UK, Germany, and Canada. Nonetheless, branded formulations for extended-release formulations maintain premium pricing, supporting higher margins.

2. Patent Expirations and Generic Competition

Patent expiry of proprietary formulations diminishes exclusivity, leading to market share erosion. Generic versions of triptorelin pamoate are now available in several jurisdictions, resulting in significant price competition. This dynamic necessitates strategic planning for pharmaceutical companies to safeguard revenue, such as through lifecycle management or development of novel formulations.

3. Advancements in Formulation Technologies

The development of longer-acting formulations reduces administration frequency, improving patient adherence and allowing premium pricing. Bioconjugates and implantable devices are in experimental stages, signaling future innovation that could influence the market.

4. Regulatory and Clinical Trial Trends

Regulatory agencies are increasingly emphasizing rigorous clinical trial data, especially concerning safety and efficacy. Approval of biosimilars or new indications can dramatically alter the competitive landscape and revenue projections.

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Financial Outlook and Revenue Forecasts

Based on current market data, the global market for triptorelin pamoate and similar GnRH agonists is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years.

• Market Valuation: In 2022, the global GnRH agonist market was valued at roughly $1.8 billion, with triptorelin pamoate representing a significant chunk, especially in prostate cancer treatments.

• Revenue Drivers: Increase in prostate cancer caseloads, expanding indications, and elongated dosing intervals contribute to longevity in revenue streams. However, growth potential hinges on market penetration rates and competitive pressures from biosimilars.

• Sales Impact of Patent Expirations: Patent cliffs in North America and Europe are expected to reduce revenues by 20-30% in the next 3-5 years unless offset by new indications or formulations.

• Emerging Markets: The Asia-Pacific region is expected to account for over 30% of the growth, driven by population aging and increasing healthcare access.

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Strategic Considerations for Stakeholders

• Pharmaceutical Companies must invest in innovation, such as developing next-generation long-acting formulations or combination therapies, to extend lifecycle and preserve market share.

• Investors should monitor patent statuses and regulatory approvals, especially concerning biosimilar developments which could impact pricing power.

• Healthcare Providers need to weigh the cost-benefit ratio of generic versus branded formulations, considering patient adherence and clinical outcomes.

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Regulatory and Ethical Factors

Regulatory agencies continue to scrutinize biosimilar approval processes, which influences market entry and competitiveness. Ethical considerations, like affordability in emerging markets, are increasingly influencing reimbursement decisions and market access strategies.

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Key Takeaways

• Triptorelin pamoate remains a key hormonal therapy for prostate cancer, endometriosis, and precocious puberty, underpinning a stable demand trajectory.

• Market growth is driven by increasing global disease prevalence, expanding indications, and longer-acting formulations, but faces headwinds from generic competition and regulatory challenges.

• Anticipated patent expiries and biosimilar entries are likely to exert downward pressure on prices, necessitating innovation and lifecycle management strategies.

• Emerging markets present significant growth opportunities, especially with improving healthcare infrastructure and awareness.

• Strategic investment in formulation innovations and geographic expansion remains crucial for maintaining and enhancing financial performance.

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FAQs

1. How does patent expiration impact the profitability of triptorelin pamoate?
Patent expiration generally leads to the introduction of generic versions, increasing competition and significantly reducing prices. This diminishes profit margins unless companies innovate or diversify their product pipeline with new formulations or indications.

2. What are the key factors influencing the adoption of long-acting triptorelin pamoate formulations?
Factors include improved patient compliance due to less frequent dosing, healthcare provider preferences, reimbursement policies, and clinical trial evidence supporting efficacy and safety.

3. How does the emergence of biosimilars affect the market for triptorelin pamoate?
Biosimilars can disrupt the market by offering lower-cost alternatives, leading to price competition, potential market share erosion, and pressure on branded drugs to justify premium pricing.

4. Which regions are expected to drive the majority of future growth for triptorelin pamoate?
Emerging markets in Asia-Pacific, Latin America, and the Middle East are poised for accelerated growth, driven by demographic shifts and expanding healthcare infrastructure.

5. What strategic moves can pharmaceutical companies make to sustain revenue post-patent expiry?
Investing in new formulations, expanding approved indications, pursuing acquisition of biosimilar assets, and entering emerging markets are critical strategies for sustaining revenue.

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References

[1] World Health Organization. (2020). Global Cancer Observatory.
[2] Bao, J., et al. (2019). Prevalence and impact of endometriosis. Reproductive Health.
[3] GlobalData. (2022). Asia-Pacific Pharmaceutical Market Forecast.