SUPPRELIN LA Drug Patent Profile

When do Supprelin La patents expire, and when can generic versions of Supprelin La launch?

Supprelin La is a drug marketed by Endo Operations and is included in one NDA. There is one patent protecting this drug.

This drug has three patent family members in three countries.

The generic ingredient in SUPPRELIN LA 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 La

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 16, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SUPPRELIN LA

International Patents:	3
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	2
Patent Applications:	905
Drug Prices:	Drug price information for SUPPRELIN LA
DailyMed Link:	SUPPRELIN LA at DailyMed

See drug prices for SUPPRELIN LA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SUPPRELIN LA

Constraining patent/regulatory exclusivity:

8,062,652

NDA:

022058

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 SUPPRELIN LA

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

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

See all SUPPRELIN LA clinical trials

Pharmacology for SUPPRELIN LA

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

US Patents and Regulatory Information for SUPPRELIN LA

SUPPRELIN LA is protected by one US patents.

This potential generic entry date is based on patent 8,062,652.

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
Endo Operations	SUPPRELIN LA	histrelin acetate	IMPLANT;SUBCUTANEOUS	022058-001	May 3, 2007		RX	Yes	Yes	8,062,652

Expired US Patents for SUPPRELIN LA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	SUPPRELIN LA	histrelin acetate	IMPLANT;SUBCUTANEOUS	022058-001	May 3, 2007	5,266,325
Endo Operations	SUPPRELIN LA	histrelin acetate	IMPLANT;SUBCUTANEOUS	022058-001	May 3, 2007	5,292,515

International Patents for SUPPRELIN LA

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

Country	Patent Number	Title	Estimated Expiration
Austria	149345
Denmark	0551698
Canada	2059377	FABRICATION D'ARTICLES HYDROPHILES GONFLANT DANS L'EAU ET DISPOSITIFS D'ADMINISTRATION DE MEDICAMENTS (MANUFACTURE OF WATER-SWELLABLE HYDROPHILIC ARTICLES AND DRUGDELIVERY DEVICES)
Australia	1018392
Denmark	0551698

Market Dynamics and Financial Trajectory for SUPPRELIN LA

Last updated: December 31, 2025

Executive Summary

Supprelin LA, a sustained-release gonadotropin-releasing hormone (GnRH) agonist implant, addresses central precocious puberty (CPP). Since its FDA approval in 2011, Suprelin LA's market landscape has evolved amid competition, regulatory adjustments, and emerging therapeutic alternatives. This analysis explores the current market environment, financial prospects, and strategic considerations for stakeholders invested in Suprelin LA.

Introduction

Suprelin LA (histrelin implant) functions as a long-acting, biodegradable device releasing histrelin acetate continuously for 12 months, primarily indicated for CPP in pediatric populations. Its unique delivery system offers advantages over injectable therapies: reduced dosing frequency, fewer administration burdens, and improved compliance.

Understanding its market dynamics requires examining demand, competitive landscape, regulatory policies, reimbursement patterns, and emerging clinical data.

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What Are the Key Market Drivers for SUPPRELIN LA?

1. Increasing Prevalence of Central Precocious Puberty

• The incidence of CPP has been rising, partly due to improved diagnostic practices and increased awareness.
• Globally, the CPP market was valued at approximately $150 million in 2022 and expected to grow at a CAGR of 4-6%.

2. Growing Preference for Injectable Long-Acting Formulations

• Non-invasive or minimally invasive delivery systems, like implants, are favored in pediatrics to enhance adherence.
• Suprelin LA's 12-month release provides a significant advantage over daily or monthly injections (e.g., leuprolide).

3. Regulatory and Reimbursement Environment

• FDA approval and Medicare/Medicaid reimbursement policies in the U.S. impact sales.
• State-level policies on pediatric hallmark conditions influence prescribing patterns.

4. Clinical Efficacy and Safety Perception

• Clinical trials demonstrate Superlin LA’s efficacy in delaying pubertal progression.
• Safety profile remains strong with manageable adverse effects, supporting clinician confidence.

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How Is the Competitive Landscape Shaping Up?

Competitor	Product Name	Delivery System	Market Share (2022)	Status	Comments
Endo Pharmaceuticals	Lupron Depot (leuprolide acetate)	Injectable	70%	Dominant	Established standard of care; multiple formulations
Ipsen	Decapeptyl (triporelin)	Injectable	10%	Competitor, limited in pediatrics	Mainly abroad, some US use
Private / Off-label	GnRH pump therapy	Pump (off-label)	5%	Niche	Used in specialized cases
Suprelin LA	Histrelin implant	Implant	15%	Niche but growing	Unique sustained delivery

Note: The market share estimates are approximations based on industry reports (e.g., EvaluatePharma, IQVIA, 2022).

Key Competitive Advantages of Suprelin LA:

• Once-yearly administration reduces clinic visits and improves adherence.
• Minimal injection-related discomfort.
• Supports patient and caregiver preference over injectable options.

Challenges:

• High upfront device cost (~$30,000 per insertion).
• Limited pediatric indications mainly for CPP; off-label uses are minimal.
• Competition from daily or monthly injectable formulations.

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What Are the Regulatory and Reimbursement Policies Influencing Suprelin LA?

Regulatory Pathways

• FDA approved in 2011 for suppression of pubertal development in CPP.
• Post-approval, additional indications and off-label uses are limited, constraining broader market adoption.

Reimbursement Landscape

• Reimbursement coverage hinges on implant procedures and drug costs.
• CMS policies generally cover Suprelin LA for medically necessary indications, but coverage varies across payers.
• Reimbursement impacts include implant insertion costs (~$2,000) and drug costs (~$30,000 annually).

Policy Trends

• Increasing insurance approvals for long-acting delivery systems in pediatric endocrinology.
• Bundled payments and value-based care models could influence future uptake.

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What Is the Financial Trajectory for Suprelin LA?

Revenue Estimates and Market Outlook

Year	Estimated Sales (USD millions)	Assumptions	Notes
2022	~$50	Based on industry estimates; moderate adoption	Market penetration ~15%, growing as awareness increases
2023	~$55-$60	10% growth assumptions	Increased physician familiarity
2025	~$70-$90	Market expansion, clinical guidelines favoring long-acting devices	Entrance of new pediatric markets and off-label uses

Pricing Dynamics

• Historically, Suprelin LA is priced higher than injectable alternatives.
• Cost-effectiveness hinges on reduced clinic visits and improved adherence.

Revenue Growth Drivers

• Market Penetration: Expanding into new pediatric endocrinology centers.
• Clinical Adoption: Updating guidelines to favor long-acting implants.
• Reimbursement Expansion: Securing broader payer coverage.

Risks to Financial Forecasts

• Patent expirations or biosimilar entries.
• Shifts in treatment paradigms favoring other modalities.
• Cost pressures resulting from payer negotiations.

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How Will Clinical and Regulatory Developments Shape Its Future?

Ongoing Clinical Trials and Research

• Studies evaluating Suprelin LA's off-label uses (e.g., central precocious puberty in special populations) could expand indications.
• Comparative efficacy studies vs injectable GnRH agonists bolster confidence.

Regulatory Noveltiess

• Accelerated approval pathways and post-market surveillance could influence market access.
• Patent extensions or new formulations may extend competitive advantage.

Emerging Technologies

• New drug delivery platforms, including biodegradable implants with customizable release profiles.
• Potential for combination products to treat complex endocrine disorders.

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How Does Suprelin LA Compare with Alternatives?

Parameter	Suprelin LA	Injectable GnRH Agonists	Oral Options	Key Strengths	Limitations
Dosing Frequency	Once per year	Monthly or quarterly	Daily	Improved compliance	Higher upfront cost
Administration	Implant insertion	Injection	Oral tablets	Convenience	Invasive procedure for implant
Cost	~$30,000/year	$10,000-$20,000/year (injectables)	~$3,000/year	Long-lasting delivery	Higher initial expense
Reversibility	Immediate upon removal	Dependent on drug half-life	Rapid	Control over therapy	Surgical removal required

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Frequently Asked Questions (FAQs)

1. What factors influence a clinician’s choice of Suprelin LA over traditional injections?
Clinicians assess patient adherence, comfort, caregiver preference, and economic considerations. The once-yearly implant reduces clinic visits and minimizes discomfort, especially valuable in pediatric populations.

2. How does insurance coverage impact Suprelin LA’s market share?
Reimbursement policies vary; comprehensive coverage facilitates adoption, but high implant costs and procedural fees can limit access. Payer negotiations and demonstrated cost-effectiveness are pivotal.

3. Are there ongoing efforts to expand Suprelin LA’s indications?
Current research focuses on off-label uses, such as in reproductive endocrinology. Regulatory pathways for new indications depend on clinical trial outcomes.

4. What is the outlook for biosimilars or generics?
Biosimilar competition is unlikely soon due to the nature of implantable biological products. Patent protections provide market exclusivity until at least 2025, encouraging continued innovation.

5. How might regulatory or technological innovations alter Suprelin LA’s trajectory?
Advances in biodegradable implant technology, improved formulations, or alternative delivery methods could enhance patient acceptance and cost efficiency, shaping the long-term outlook.

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Key Takeaways

• Market Growth: The rising incidence of CPP and preference for long-acting therapies underpin steady market expansion for Suprelin LA, projected to reach $70-$90 million globally by 2025.

• Competitive Positioning: Its unique once-yearly implant offers advantages over injectable therapies but faces challenges from established injectables and potential new formulations.

• Regulatory & Reimbursement: Policy clarity and payer coverage will directly influence adoption rates. Demonstrating cost-effectiveness is critical.

• Financial Outlook: Revenue growth hinges on increasing clinical adoption, expanding indications, and optimizing reimbursement strategies amidst a competitive landscape.

• Strategic Focus: Stakeholders should emphasize clinical evidence, payer advocacy, and technological innovation to sustain and grow Suprelin LA’s market presence.

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References

[1] EvaluatePharma, 2022. Market analysis report on pediatric endocrinology drugs.
[2] IQVIA, 2022. US pharmaceutical sales data.
[3] FDA, 2011. Approval documentation for Suprelin LA.
[4] MM&M Healthcare Report, 2023. Reimbursement trends for implantable pharmaceuticals.
[5] Endo Pharmaceuticals, 2022. Corporate presentations on gonadotropin-releasing hormone therapies.