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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:	3
Clinical Trials:	2
Patent Applications:	893
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
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)
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)
Canada	2570960	COMPOSITIONS ET METHODES DE TRAITEMENT DE LA PUBERTE CENTRALE PRECOCE (COMPOSITIONS AND METHODS FOR TREATING CENTRAL PRECOCIOUS PUBERTY)
Australia	651654
Denmark	0551698
Austria	149345

SUPPRELIN LA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SUPPRELIN LA

Introduction

SUPPRELIN LA, a subcutaneous implant containing histrelin acetate, is a crucial treatment for central precocious puberty (CPP), a condition where children enter puberty earlier than usual. This article delves into the market dynamics and financial trajectory of SUPPRELIN LA, highlighting its efficacy, market size, and financial performance.

Efficacy and Clinical Significance

SUPPRELIN LA has been proven to maintain profound hormone suppression in children with CPP. A two-year study confirmed that the implant continues to suppress peak hormone and sex steroid levels without breakthroughs, leading to decreased growth velocity, skeletal maturation, and body mass index[1].

Clinical Outcomes

• The study showed significant reductions in peak LH levels and growth velocity over the two-year period.
• There were no escapes or breakthroughs of hormones, indicating sustained efficacy[1].

Patient Compliance

The once-yearly administration of SUPPRELIN LA enhances patient compliance compared to traditional injections, which may require more frequent dosing[1].

Market Size and Growth

The global central precocious puberty (CPP) treatment market, which includes SUPPRELIN LA, is projected to grow significantly.

Current Market Size

As of 2024, the global CPP treatment market was valued at USD 1.84 billion[4].

Forecasted Growth

The market is expected to reach USD 3.31 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 7.60% during the forecast period of 2025 to 2032[4].

Regional Dominance

North America dominates the CPP treatment market due to its well-established healthcare infrastructure. The Asia-Pacific region is also expected to grow due to increasing healthcare expenditure and rising incidences of obesity[4].

Financial Performance of SUPPRELIN LA

SUPPRELIN LA is part of the portfolio of Endo International plc, a pharmaceutical company that reports financial results for its various segments.

Revenue Contribution

While specific revenue figures for SUPPRELIN LA are not separately disclosed, it falls under the branded pharmaceuticals segment of Endo International. In the first quarter of 2024, Endo reported total revenues of $420 million, with branded pharmaceuticals contributing a significant portion[5].

Segment Performance

• Branded Pharmaceuticals: This segment, which includes SUPPRELIN LA, reported revenues within the range of $860 million to $905 million for the full year 2024 forecast[5].

Overall Financial Health

Endo International has experienced fluctuations in its financial performance. For instance, in the third quarter of 2024, the company reported a net loss of $381.5 million, although adjusted EBITDA showed a positive trend at $151.3 million[2].

Competitive Landscape

The CPP treatment market is competitive, with various medications and treatment options available.

Market Players

Major players in the CPP treatment market focus on novel technologies and treatments, which drives market growth. SUPPRELIN LA, with its unique once-yearly implant, stands out due to its convenience and efficacy[4].

Distribution and End-Users

The distribution channels for SUPPRELIN LA include hospital pharmacies, retail pharmacies, and online pharmacies.

End-Users

The primary end-users are hospitals, specialty clinics, and homecare settings. The convenience of the once-yearly implant makes it a preferred option for both patients and healthcare providers[4].

Regulatory and Safety Considerations

SUPPRELIN LA is approved by the U.S. Food and Drug Administration (FDA) and has specific regulatory and safety guidelines.

FDA Approval

Approved on May 3, 2007, SUPPRELIN LA utilizes the patented HYDRON Polymer Technology for continuous release of histrelin acetate over 12 months[1].

Safety Profile

Common adverse reactions include implant site reactions, and there have been postmarketing reports of psychiatric events and convulsions. Proper surgical technique during insertion and removal is critical to minimize adverse events[3].

Key Takeaways

• Efficacy: SUPPRELIN LA maintains profound hormone suppression in children with CPP, enhancing patient compliance.
• Market Growth: The global CPP treatment market is projected to grow from USD 1.84 billion in 2024 to USD 3.31 billion by 2032.
• Financial Performance: SUPPRELIN LA contributes to the branded pharmaceuticals segment of Endo International, which has shown mixed financial results but positive adjusted EBITDA.
• Competitive Landscape: The market is competitive, with SUPPRELIN LA standing out due to its unique once-yearly administration.
• Distribution and End-Users: The drug is distributed through various channels and used in hospitals, specialty clinics, and homecare settings.

FAQs

What is SUPPRELIN LA used for?

SUPPRELIN LA is used for the treatment of central precocious puberty (CPP) in children, delaying the onset of early puberty.

How often is SUPPRELIN LA administered?

SUPPRELIN LA is administered once every 12 months via a subcutaneous implant.

What are the common adverse reactions to SUPPRELIN LA?

Common adverse reactions include implant site reactions, such as discomfort, bruising, and soreness. There have also been reports of psychiatric events and convulsions[3].

Who are the primary end-users of SUPPRELIN LA?

The primary end-users are hospitals, specialty clinics, and homecare settings.

What is the projected growth rate of the CPP treatment market?

The global CPP treatment market is expected to grow at a CAGR of 7.60% from 2025 to 2032[4].

What technology does SUPPRELIN LA use for its continuous release?

SUPPRELIN LA uses the patented HYDRON Polymer Technology for continuous release of histrelin acetate over 12 months[1].

Sources

1. Indevus Pharmaceuticals, Inc. - "Two Year Study Confirms SUPPRELIN LA Demonstrates Continued Profound Hormone Suppression in Children with Central Precocious Puberty" - BioSpace.
2. Endo - "Endo Reports Third-Quarter 2024 Financial Results and Reaffirms 2024 Guidance" - StockTitan.
3. FDA - "SUPPRELIN LA (histrelin acetate) subcutaneous implant" - FDA.
4. Data Bridge Market Research - "Global Central Precocious Puberty (CPP) Treatment Market" - Data Bridge Market Research.
5. Endo International plc - "Endo Provides Select First-Quarter 2024 Financial Results for Endo International plc" - Endo Investor Relations.