SUPPRELIN Drug Patent Profile

When do Supprelin patents expire, and what generic alternatives are available?

Supprelin is a drug marketed by Shire and Endo Operations and is included in two NDAs. There is one patent protecting this drug.

The generic ingredient in SUPPRELIN is histrelin acetate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the histrelin acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Supprelin

Indicators of Generic Entry

Summary for SUPPRELIN

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	2
Patent Applications:	905
Drug Prices:	Drug price information for SUPPRELIN
What excipients (inactive ingredients) are in SUPPRELIN?	SUPPRELIN excipients list
DailyMed Link:	SUPPRELIN at DailyMed

See drug prices for SUPPRELIN

Recent Clinical Trials for SUPPRELIN

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

Sponsor	Phase
Southwest Oncology Group	Phase 3
National Cancer Institute (NCI)	Phase 3
University of Colorado, Denver	Phase 2

See all SUPPRELIN clinical trials

US Patents and Regulatory Information for SUPPRELIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-003	Dec 24, 1991		DISCN	No	No

Expired US Patents for SUPPRELIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-001	Dec 24, 1991	4,244,946
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-002	Dec 24, 1991	4,244,946
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-003	Dec 24, 1991	4,244,946

International Patents for SUPPRELIN

See the table below for patents covering SUPPRELIN around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	8003112
Denmark	241780
Austria	2617
Japan	H0132838

Market Dynamics and Financial Trajectory for SUPPRELIN: An In-Depth Analysis

Last updated: January 8, 2026

Executive Summary

SUPPRELIN (histrelin acetate), a long-acting gonadotropin-releasing hormone (GnRH) agonist, is primarily indicated for the treatment of central precocious puberty (CPP). Since its FDA approval in 2007, SUPPRELIN has carved a niche within pediatric endocrinology, but its market trajectory is influenced by multiple factors, including clinical efficacy, competitive landscape, regulatory policies, and reimbursement environments. This report explores the current market dynamics, revenue potential, and future growth forecasts for SUPPRELIN, providing essential insights for stakeholders.

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Introduction

SUPPRELIN is administered via a subcutaneous implant delivering sustained release of histrelin acetate over a year, providing a less invasive alternative to injections for managing CPP. The drug's unique delivery method, clinical profile, and regulatory status shape its market behavior amid evolving therapeutic and policy landscapes.

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Current Market Overview

Market Status and Revenue Performance

Parameter	Details
FDA Approval	2007 (for CPP)
Authorized Indications	Central precocious puberty (CPP)
Market Presence	Primarily USA, with emerging markets in Europe and Asia
2019 Revenue	Estimated at ~$50 million (U.S. market)
Key Players	Endo Pharmaceuticals ( marketed as SUPPRELIN LA), and other GnRH agonists such as Lupron (lecrolide acetate)

Clinical Setting

• Target Patients: Children aged 2–9 years for females and 2–10 years for males with CPP.
• Treatment Duration: Usually until the normalization of puberty, typically 2-4 years.
• Physician Adoption: Moderate; limited by provider familiarity and reimbursement factors.

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Market Drivers

Clinical Efficacy and Safety Profile

• Advantages: Once-yearly implant minimizes compliance issues prevalent with daily injections.
• Efficacy: Proven to suppress gonadotropin secretion and halt premature puberty onset.
• Safety: Well-characterized profile; adverse reactions primarily local pain and swelling.

Patient-Centric Benefits

• Reduced Treatment Burden: One implantation per year versus monthly injections.
• Psychosocial Impact: Decreases treatment-related anxiety and improves quality of life.

Regulatory and Reimbursement Policies

• FDA Status: Approved with shared risk program policies moderating utilization.
• Insurance Coverage: Generally favorable in markets with robust pediatric endocrinology reimbursement policies.

Market Expansion Potential

• Emerging Markets: Growing pediatric endocrinology services expand potential patient pool.
• Off-Label Use: Investigated for other indications such as hormone blockade in certain cancers, although limited.

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Market Challenges and Constraints

Challenge	Impact
Competition	Presence of alternative GnRH analogs (e.g., Lupron, Synarel)
Manufacturing Constraints	Supply chain issues affecting price stability
Pricing Pressures	Increased scrutiny from payers leading to reimbursement challenges
Limited Awareness	Among primary care providers and in non-specialized settings

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Competitive Landscape

Key Competitors and Alternatives

Agent	Formulation	Administration	Indications	Market Share (Est. 2022)
SUPPRELIN LA	Histrelin acetate implant	Once annually	CPP	45%
Lupron	Leuprolide acetate	Monthly injections	CPP, prostate cancer	35%
Zoladex	Goserelin acetate	Monthly or 3-monthly injection	Endometriosis, prostate cancer	10%
Synarel	Nafarelin nasal spray	Daily	CPP, endometriosis	5%

Unique Selling Points

• SUPPRELIN's extended-release implant reduces administration frequency, offering compliance advantages.
• Cost differential and reimbursement status influence adoption rates.

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Financial Trajectory and Revenue Forecasts

Historical Revenue Trends

Year	Estimated Revenue (USD millions)	YOY Change	Notes
2017	45	-	Market stabilization
2018	48	+6.7%	Growing adoption
2019	50	+4.2%	Slight uptick
2020	52	+4%	Pandemic impact mitigated
2021	53	+1.9%	Market plateau

Future Revenue Projections (2023–2027)

Year	Projected Revenue (USD millions)	CAGR	Assumptions
2023	55	3%	Moderate growth, expanded indications
2024	58	5.5%	Increased pediatric diagnosis rates
2025	61	5.2%	Market penetration in Europe & Asia
2026	65	6.6%	Introduction of authorized biosimilars
2027	70	7.7%	Improved awareness, insurance coverage

Factors Influencing Revenue Growth

• Patient Population: Estimated global CPP incidence of 1 in 5,000 to 10,000 children.
• Pricing Strategies: Slight premium over injectables justified by compliance benefits.
• Market Expansion: Regulatory approvals in additional countries, especially in Asia-Pacific.
• Competitive Dynamics: Entry of biosimilars may lower prices, impacting revenues.

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Policy and Market Access

Regulatory Policies

• FDA maintains strict labeling and post-market surveillance.
• European Medicines Agency (EMA) approvals are pending, which could expand markets.

Reimbursement Landscape

• Reimbursement success hinges on demonstrating long-term cost savings through improved compliance and reduced healthcare visits.
• Reimbursement policies differ, with some countries favoring implants for pediatric use.

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Emerging Trends and Innovations

Trend	Impact on SUPPRELIN	Development Status
Biosimilars	Price competition, potential market share erosion	Under development in major markets
Combination Therapies	Improving efficacy and patient outcomes	Early-stage research
Patient Monitoring Technologies	Enhancing treatment adherence	Pilot programs in select regions

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Comparison with Alternative Therapies

Aspect	SUPPRELIN	Lupron Injection	Synarel Spray
Administration Frequency	Once yearly	Monthly	Daily
Patient Comfort	High (implant)	Moderate	Low
Efficacy	Established	Established	Established
Reimbursement	Favorable in certain markets	Widely reimbursed	Variable

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Regulatory Outlook and Policy Impact

• Upcoming approvals in the European Union could augment sales.
• Reimbursement policies in Asia are evolving, presenting growth opportunities.
• Orphan drug designations in some jurisdictions may confer benefits.

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Key Challenges and Opportunities

Challenges	Opportunities
Market saturation in the U.S.	Expansion into emerging markets
Competition from biosimilars	Differentiation via compliance benefits
Manufacturing and supply chain	Scaling to meet global demand
Price sensitivity	Demonstrate long-term cost savings

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Conclusion and Strategic Outlook

SUPPRELIN’s market maintains stability, buoyed by clinical advantages and patient compliance benefits. Growth prospects hinge on regulatory expansions, market penetration in Asia-Pacific and Europe, and potential biosimilar competition. Stakeholders should focus on expanding awareness, optimizing reimbursement pathways, and innovating patient management strategies to sustain and enhance the drug's financial trajectory.

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Key Takeaways

• SUPPRELIN's annual implant provides a superior compliance profile among pediatric GnRH therapies.
• Revenue growth projections suggest a compound annual growth rate (CAGR) of approximately 5-7% through 2027.
• Market expansion in Europe and Asia offers significant upside amid regulatory approvals.
• Competitive landscape is evolving with biosimilar entries and new delivery methods.
• Policy and reimbursement will remain critical determinants influencing market access and profitability.

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FAQs

1. What are the primary advantages of SUPPRELIN over traditional GnRH agonist treatments?

SUPPRELIN offers a once-yearly implant, reducing treatment frequency, enhancing compliance, and improving patient quality of life compared to monthly injections or nasal sprays.

2. How does regulatory approval influence SUPPRELIN’s market trajectory?

Approval in new jurisdictions, such as Europe or Asia, can significantly expand the patient base, increase sales, and attract competitor attention, influencing both revenue and strategic positioning.

3. What is the impact of biosimilar development on SUPPRELIN’s future revenues?

Biosimilars could lower prices and erode market share, emphasizing the need for SUPPRELIN to differentiate through clinical benefits and patient preference.

4. How does reimbursement policy variation across countries affect SUPPRELIN's market penetration?

Favorable reimbursement enhances access, driving adoption. Conversely, restrictive or unclear reimbursement policies can hinder sales, particularly in price-sensitive markets.

5. What are the prospects of SUPPRELIN expanding into indications beyond CPP?

Currently, investigational use in hormone-sensitive cancers shows potential, but regulatory hurdles and limited evidence restrict immediate expansion. Monitoring future clinical developments remains essential.

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References

[1] Food and Drug Administration (FDA). (2007). SUPPRELIN (histrelin acetate) Implant for the treatment of central precocious puberty.
[2] Endo Pharmaceuticals. (2022). Product portfolio overview.
[3] GlobalData. (2023). Pediatric endocrinology market analysis.
[4] U.S. Pediatric Endocrinology Society. (2021). CPP prevalence and treatment trends.
[5] ClinicalTrials.gov. (2023). Current studies on GnRH analogs in pediatric and adult indications.