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
Southwest Oncology Group	Phase 3
National Cancer Institute (NCI)	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
Denmark	0551698
European Patent Office	0551698	Fabrication d'articles hydrophiles hydro-gonflables et dispositifs de délivrance de médicaments (Manufacture of water - swellable hydrophilic articles and drug delivery devices)
Germany	69217900

Market Dynamics and Financial Trajectory for SUPPRELIN LA

Last updated: July 27, 2025

Introduction

SUPPRELIN LA (histrelin implant) is a long-acting, subcutaneous hormonal therapy used primarily to manage central precocious puberty (CPP) in pediatric patients and treat certain adult conditions such as prostate cancer. Since its FDA approval in 2005, SUPPRELIN LA has carved a niche within the hormonal and pediatric markets, characterized by a unique mode of administration and targeted indications. Analyzing its market dynamics and financial trajectory reveals critical insights into its commercial potential, challenges, and strategic positioning.

Market Landscape and Key Drivers

1. Therapeutic Indications and Unmet Needs

SUPPRELIN LA is primarily indicated for CPP, a rare pediatric disorder characterized by early onset puberty, which affects approximately 1 in 5,000 children (as per the Pediatric Endocrine Society). Managing CPP effectively delays early puberty and its associated psychosocial and developmental complications.

Additionally, off-label use includes hormone suppression in prostate cancer and other hormone-dependent conditions in adults, broadening its market scope. The specialized nature of its indications maintains a relatively niche market, with consistent demand driven by pediatric endocrinology and oncology practices.

2. Market Penetration and Adoption Trends

Despite its proven efficacy, SUPPRELIN LA faces competition from alternative therapies, including depot formulations of leuprolide acetate (e.g., Lupron Depot) and other implantable or oral hormonal agents. However, its monthly or quarterly dosing schedule provides a convenience advantage over daily administrations, thus promoting patient compliance and adherence.

Switching trends, increased pediatric endocrinology training, and caregiver familiarity with implantable devices have positively influenced uptake. Despite dealing with a limited patient population, the device's ease of use and reduced treatment burden foster steady market penetration.

3. Competitive Dynamics

The primary competition stems from other GnRH agonist therapies and emerging treatment modalities, such as oral formulations and subcutaneous pellets. Price positioning, reimbursement policies, and provider preferences influence pharmaceutical companies' strategic decisions and market share allocations.

Moreover, advancements in drug delivery technologies and biosimilar developments could impact SUPPRELIN LA's market hold. Yet, patent protections and exclusive licensing agreements sustain its competitive edge in the mid-term.

4. Regulatory and Reimbursement Environment

The regulatory landscape influences market dynamics significantly. SUPPRELIN LA's approval by the FDA facilitated access in the U.S., but ongoing reimbursement challenges and evolving insurance policies can influence prescribing behaviors. The acquisition of reimbursement codes and incorporation into standard treatment guidelines are crucial for sustained sales growth.

Market Opportunities and Challenges

1. Growth Potential in Pediatric and Adult Markets

The adult market segment, particularly prostate cancer, remains an underexploited pathway. Although off-label utilization exists, lack of formal approval limits significant commercialization. However, expanding indications and educational outreach could stimulate higher acceptance.

Furthermore, pediatric demographic trends and early intervention awareness support consistent demand. Expanding geographic reach, particularly in emerging markets with rising healthcare investment, can unlock additional growth avenues.

2. Challenges: Market Saturation and Market Entry Barriers

In established markets such as the U.S. and Europe, saturation levels are moderate owing to the relatively small target population. Entry barriers include high R&D costs, regulatory approvals, and patent exclusivity periods. Reimbursement reforms and shifts toward oral therapies could threaten long-term viability unless the company innovates further.

3. Impact of Innovation and Lifecycle Management

To prolong its market relevance, companies are exploring enhancements in device technology, such as biodegradable implants or combination therapies. Lifecycle extension strategies, including line extensions and new indication approvals, could stabilize revenues.

Financial Trajectory Analysis

1. Revenue Generation and Market Share Evolution

SUPPRELIN LA’s revenue trajectory exhibits a steady incline since launch, driven by persistent demand within its primary indications. The annual global sales are estimated to be in the low hundreds of millions USD, with North America constituting the majority share due to high prevalence and superior reimbursement measures.

Market penetration rates have increased modestly due to ongoing physician education and insurance acceptance. The company's strategic investments in targeted marketing and clinical evidence generation support revenue stability.

2. Cost Structures and Profitability

Manufacturing costs for implantable devices remain relatively high, reflecting the sophisticated production process and regulatory compliance investments. Margins are maintained through optimized supply chain management and economies of scale.

Profitability is heavily reliant on sales volume growth and market penetration. Competitive pricing, reimbursement negotiations, and cost control are critical levers influencing financial performance.

3. Impact of Patent and Exclusivity

Patent protections and data exclusivity periods secure temporary market monopolies, enabling premium pricing strategies. As patents expire, generic competition may erode margins unless new formulations or indications extend the product lifecycle.

4. Market Risks and Financial Outlook

Market risks include regulatory hurdles, reimbursement challenges, and emerging therapies. Fluctuations in healthcare policy and payer coverage influence revenue stability. Nonetheless, the product's entrenched position in niche markets supports a cautiously optimistic long-term financial outlook, assuming sustained clinical demand and innovation.

Future Outlook and Strategic Considerations

The trajectory of SUPPRELIN LA hinges on clinical adoption, regulatory developments, and lifecycle management. Incorporating digital health tools, expanding indications, and fostering global partnerships may propel growth. Strategic investments in R&D, coupled with proactive regulatory engagement, will mitigate risks and sustain competitive advantages.

Concurrently, monitoring reimbursement policies and healthcare spending trends remains critical. Companies should also explore alliances with healthcare systems to embed SUPPRELIN LA into standard care pathways, enhancing revenue continuity.

Key Takeaways

• Niche yet Stable Demand: SUPPRELIN LA commands a steady, niche market driven by pediatric endocrinology and select adult conditions, with demand fuelled by treatment efficacy and patient compliance benefits.

• Competitive Positioning: Its unique implantable delivery mode offers differentiation, though competition from alternative hormonal therapies persists. Continuous innovation is necessary to maintain market share.

• Regulatory and Reimbursement Factors: Success relies heavily on navigating regulatory pathways and securing reimbursement approvals, especially in expanding geographies.

• Revenue and Profitability Outlook: While mature markets provide consistent revenue streams, future growth depends on indications expansion, market penetration, and lifecycle management strategies.

• Potential for Growth: Emerging markets and additional therapeutic indications present opportunities; however, pricing pressures and biosimilar threats pose challenges.

FAQs

1. What are the primary indications for SUPPRELIN LA?
SUPPRELIN LA is mainly approved for central precocious puberty in pediatric patients. Off-label, it is used for hormone suppression in prostate cancer and other hormone-dependent conditions.

2. How does SUPPRELIN LA compare to alternative therapies?
Its implantable, long-acting formulation offers improved compliance over daily injections or oral medications. However, competition exists from other GnRH analogs, impacting market share.

3. What are the key factors driving its market growth?
Factors include increasing diagnosis rates of CPP, preference for long-acting therapies, technological advances in implant devices, and expanding awareness within pediatric care.

4. What challenges does SUPPRELIN LA face in maintaining its market position?
Market saturation, competition from biosimilars or oral drugs, reimbursement uncertainties, regulatory hurdles, and patent expirations threaten long-term growth.

5. What strategic moves can enhance SUPPRELIN LA’s financial trajectory?
Augmenting indications, expanding into emerging markets, pursuing device innovation, strengthening regulatory and reimbursement pathways, and engaging in strategic collaborations are key measures.

References

[1] Pediatric Endocrine Society. (2020). Central Precocious Puberty Overview.
[2] U.S. Food and Drug Administration. (2005). SUPPRELIN LA Approval Notice.
[3] Market Research Future. (2022). Hormonal Disorder Treatment Market Analysis.
[4] Company filings and annual reports related to SUPPRELIN LA sales data.
[5] Peer-reviewed literature on CPP epidemiology and treatment trends.