HISTRELIN ACETATE - Generic Drug Details

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

Histrelin acetate is the generic ingredient in three branded drugs marketed by Endo Operations and Shire, and is included in three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Histrelin acetate has three patent family members in three countries.

There is one drug master file entry for histrelin acetate. One supplier is listed for this compound.

Summary for HISTRELIN ACETATE

International Patents:	3
US Patents:	1
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	5
What excipients (inactive ingredients) are in HISTRELIN ACETATE?	HISTRELIN ACETATE excipients list
DailyMed Link:	HISTRELIN ACETATE at DailyMed

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

Constraining patent/regulatory exclusivity:

8,062,652

Dosage:

IMPLANT;SUBCUTANEOUS

^*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 HISTRELIN ACETATE

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

Sponsor	Phase
NRG Oncology	Phase 3
National Cancer Institute (NCI)	Phase 3
Southwest Oncology Group	Phase 3

See all HISTRELIN ACETATE clinical trials

Pharmacology for HISTRELIN ACETATE

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

Anatomical Therapeutic Chemical (ATC) Classes for HISTRELIN ACETATE

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

US Patents and Regulatory Information for HISTRELIN ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	VANTAS	histrelin acetate	IMPLANT;SUBCUTANEOUS	021732-001	Oct 12, 2004		DISCN	Yes	No
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-001	Dec 24, 1991		DISCN	No	No
Endo Operations	SUPPRELIN LA	histrelin acetate	IMPLANT;SUBCUTANEOUS	022058-001	May 3, 2007		RX	Yes	Yes	8,062,652
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-002	Dec 24, 1991		DISCN	No	No

Expired US Patents for HISTRELIN ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-003	Dec 24, 1991	4,244,946
Endo Operations	SUPPRELIN LA	histrelin acetate	IMPLANT;SUBCUTANEOUS	022058-001	May 3, 2007	5,266,325
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-002	Dec 24, 1991	4,244,946
Endo Operations	VANTAS	histrelin acetate	IMPLANT;SUBCUTANEOUS	021732-001	Oct 12, 2004	5,292,515

International Patents for HISTRELIN ACETATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1773293	COMPOSITIONS ET METHODES DE TRAITEMENT DE LA PUBERTE CENTRALE PRECOCE (COMPOSITIONS AND METHODS FOR TREATING CENTRAL PRECOCIOUS PUBERTY)
Canada	2570960	COMPOSITIONS ET METHODES DE TRAITEMENT DE LA PUBERTE CENTRALE PRECOCE (COMPOSITIONS AND METHODS FOR TREATING CENTRAL PRECOCIOUS PUBERTY)
World Intellectual Property Organization (WIPO)	2006009801

Market Dynamics and Financial Trajectory for Histrelin Acetate

Last updated: July 27, 2025

Introduction

Histrelin acetate, a potent gonadotropin-releasing hormone (GnRH) agonist, has carved a niche in the therapeutic landscape, primarily treating central precocious puberty (CPP) and prostate cancer. As a long-acting implant administered subcutaneously, its unique delivery system offers convenience and adherence advantages, fueling its adoption across healthcare settings. This article assesses the intricate market dynamics and financial trends shaping histrelin acetate, providing critical insights for stakeholders considering investment, development, or competitive positioning.

Therapeutic Landscape and Market Drivers

Clinical Applications and Market Penetration

Central Precocious Puberty (CPP): The primary approved indication for histrelin acetate involves delaying early onset puberty in children, thereby mitigating psychosocial and developmental complications. The rising recognition of CPP's long-term effects increases demand for effective therapies like histrelin implants.

Prostate Cancer: In adult men, histrelin acetate serves as a menopausal suppression agent and palliative treatment for hormone-sensitive prostate cancer. Aging populations in developed countries underpin the rising prevalence, expanding market potential.

Advantages Promoting Adoption

• Long-acting formulation: The 12-month subcutaneous implant enhances adherence, reduces clinic visits.
• Minimal systemic side effects: Due to its targeted delivery, it improves patient tolerability.
• Simplified dosing regimen: Advantages over daily or monthly injectables.

Key Market Drivers

• Increasing incidence of CPP globally, notably in pediatric populations.
• Aging demographics escalating prostate cancer prevalence.
• Growing preference for sustained-release biologic therapies.
• Rising awareness and improved diagnostic techniques for early puberty onset.
• Healthcare system shifts favoring outpatient, minimally invasive treatments.

Market Constraints and Challenges

• Cost considerations: The high per-injection cost, attributed to manufacturing and delivery device complexity, may impede affordability, especially in developing economies.
• Limited indications: Currently approved primarily for CPP and prostate cancer, constraining expansive market growth.
• Regulatory hurdles: Navigating approval processes in emerging markets presents obstacles.
• Competitive landscape: Established GnRH analogs like leuprolide and goserelin, available in multiple formulations, pose significant competition.

Competitive Dynamics and Market Players

Manufacturers and Market Share

Key players include Florence Healthcare, Tolmar Pharmaceuticals, and Ferring Pharmaceuticals, the latter being notable for its heralded Relinq implant. Market dominance varies regionally based on regulatory approvals and cardiovascular reimbursement policies.

Pricing Strategies and Reimbursement

Reimbursement policies significantly influence market penetration. In the U.S., the implant's coverage under Medicaid and private insurance facilitates access. Conversely, high costs may limit utilization in lower-income regions, influencing overall revenue streams.

Patent Landscape and Generic Competition

Patent protection extends through 2025-2030 for key formulations, but imminent patent expirations could pave the way for generics, intensifying price competition and shrinking margins.

Market Size and Financial Trajectory

Global Market Valuation and Growth Prospects

Current estimates place the global market for histrelin acetate and similar GnRH analogs at approximately $400-500 million (2022), with projections indicating compound annual growth rates (CAGR) of 6-8% over the next five years [1]. The growth trajectory hinges on demographic shifts, therapeutic approvals, and technological advances.

Regional Market Dynamics

• North America: Dominates due to high prevalence of CPP diagnosis, robust healthcare infrastructure, and reimbursement frameworks.
• Europe: Growing acceptance, aligning with demographic trends; faced with heterogenous regulations.
• Asia-Pacific: Emerging market, driven by increasing awareness, improving healthcare access, and pediatric endocrinology advancements.

Financial Trends and Revenue Drivers

Revenue growth is anticipated from:

• Expansion in diagnosed and treated pediatric populations.
• Off-label use for other indications, such as endometriosis (although not currently approved).
• Patent expiry-driven entry of generics, reducing prices but broadening access.

Future Outlook

Development of biosimilar versions and novel delivery mechanisms could disrupt existing revenue streams but also present opportunities for market share expansion. Investment in clinical trials for expanded indications, such as hormone-sensitive cancers, may further diversify revenue sources.

Regulatory and Market Access Considerations

Regulatory Environment

Stringent approval processes across jurisdictions influence launch timelines. Successful navigation can accelerate revenue generation avenues. The EMA, FDA, and emerging markets’ agencies evaluate safety, efficacy, and manufacturing standards.

Market Access and Pricing Policies

Cost-effectiveness analyses favor long-acting implants by decreasing healthcare resource utilization. Reimbursement policies will remain pivotal in determining the geographical spread and market capture.

Risk Factors Impacting Market and Financial Trajectory

• Patent expirations introduce generic competition.
• Potential shifts in treatment guidelines affecting pediatric and oncology indications.
• Pricing pressures due to healthcare reforms.
• Clinical development risks related to new indications or formulations.
• Alternative therapies with similar efficacy may erode market share.

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Key Takeaways

• Growing Demand: The demographic trend toward an aging population and increasing pediatric diagnoses underpins a steady rise in histrelin acetate demand.
• Competitive Positioning: Market success hinges on differentiation through convenience, cost-effectiveness, and regulatory approval breadth.
• Pricing Strategy Sensitivity: High device costs demand effective pricing models aligned with reimbursement policies to maximize market penetration.
• Pipeline Expansion: Investigating additional indications, such as endometriosis or other hormone-dependent diseases, could diversify revenue streams.
• Patent and Market Dynamics: The potential entry of generics post-patent expiration may pressure margins but also expand access.

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FAQs

1. What are the main therapeutic indications for histrelin acetate?
Primarily, histrelin acetate is used to treat central precocious puberty in children and as a palliative for hormone-sensitive prostate cancer in adults.

2. How does the implant delivery system influence market adoption?
The long-acting, minimally invasive implant enhances patient compliance, reduces healthcare visits, and positions histrelin acetate favorably against monthly or quarterly injections, supporting broader adoption.

3. What are the key factors impacting the financial growth of histrelin acetate?
Demographics, reimbursement policies, patent protections, development of generics, competitive landscape, and approval of new indications significantly influence financial outcomes.

4. How does regional regulation affect market potential?
Regulatory approvals determine access; regions with streamlined approval processes and favorable reimbursement policies facilitate faster and greater market penetration.

5. What strategies can manufacturers employ to sustain market leadership?
Investing in clinical trials for new indications, advancing delivery technologies, engaging with payers for favorable coverage, and managing patent timelines are vital.

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References

[1] GlobalData Healthcare. "GnRH Agonists Market Analysis and Forecast." 2022.