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.

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Indicators of Generic Entry

Summary for SUPPRELIN

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	35
Clinical Trials:	2
Patent Applications:	4,408
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	019836-003	Dec 24, 1991	4,244,946
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-002	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 Korea	850001158
Japan	S565448	ORGANIC COMPOUND
Canada	1154758	PEPTIDES HYDROSOLUBLES AYANT UNE ACTION SUR LES GONADES (WATER-SOLUBLE PEPTIDES AFFECTING GONADAL FUNCTION)
Japan	H0132838
Germany	3062118

SUPPRELIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SUPPRELIN LA

Introduction

SUPPRELIN LA, a histrelin acetate subcutaneous implant, is a pivotal 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 growth, and financial implications.

Efficacy and Clinical Outcomes

SUPPRELIN LA has demonstrated remarkable efficacy in clinical trials. A two-year study confirmed that the implant maintains profound hormone suppression with no breakthroughs, leading to decreased growth velocity, skeletal maturation, and body mass index in children with CPP[1].

Market Size and Growth

The Europe Central Precocious Puberty (CPP) treatment market, which includes SUPPRELIN LA, is projected to grow significantly. By 2030, the market is expected to reach USD 857.65 million, growing at a CAGR of 6.7% from its base year value of USD 510.50 million in 2022[4].

Key Market Drivers

Several factors drive the growth of the CPP treatment market, including SUPPRELIN LA:

Increasing Product Launches and Collaborations

Major pharmaceutical companies are engaging in collaborations and launching new products, which enhances the market growth. For instance, collaborations like the one between AbbVie Inc. and Scripps Research have improved drug development processes, contributing to the economic benefits of these companies[4].

Rising Prevalence of CPP in Girls

The prevalence of CPP is higher in girls than in boys, with approximately one in every 5,000 to 10,000 girls affected. This higher prevalence in the female population drives the demand for treatments like SUPPRELIN LA[4].

Adoption of Direct Tender Segment

The direct tender channel has increased the accessibility of CPP treatments, including SUPPRELIN LA, by offering these drugs at reasonable prices and for extended treatment periods. This has enhanced market growth[4].

Market Restraints

Despite the growth drivers, there are challenges that affect the market:

High Cost of Treatment

The high cost of CPP treatments, including surgery and medications like SUPPRELIN LA, is a significant barrier. This cost can be prohibitive for lower economic groups, hindering market growth[4].

Financial Trajectory

Revenue Projections

The increasing demand for CPP treatments, driven by factors like rising prevalence and new product launches, is expected to boost the revenue of SUPPRELIN LA. The market's projected growth to USD 857.65 million by 2030 indicates a positive financial trajectory for this drug[4].

Copay Assistance Programs

To mitigate the high cost of treatment, programs like the SUPPRELIN LA SHARES Copay Assistance Program offer significant financial relief. Eligible patients may save up to $6,000, making the treatment more accessible and potentially increasing market penetration[2].

Prescription Drug Spending Trends

Overall prescription drug spending is projected to grow from $500 billion in 2018 to $863 billion by 2028, with retail and nonretail components contributing to this growth. This trend suggests a favorable environment for pharmaceuticals like SUPPRELIN LA, although it also highlights the need for cost management and policy reforms to control spending[3].

Competitive Landscape

SUPPRELIN LA competes with other GnRH agonists such as Triptorelin and Lupron Depot-Ped (leuprolide acetate). The competitive landscape is driven by the efficacy, convenience, and cost-effectiveness of these treatments. SUPPRELIN LA's once-yearly subcutaneous implant offers a unique advantage in terms of compliance and convenience, which can influence market share[4].

Policy Implications

Efforts to increase transparency and reduce prescription drug spending will continue to impact the market. Policies aimed at promoting competition among drug manufacturers, reducing pay-for-delay deals, and promoting biosimilar use could affect the pricing and market dynamics of SUPPRELIN LA and similar drugs[3].

Patient and Physician Perspectives

Compliance and Convenience

SUPPRELIN LA's once-yearly administration is a significant advantage, as it reduces the compliance issues associated with frequent injections. This convenience is particularly appreciated by patients and families managing CPP, as highlighted by Dr. Gad Kletter, who noted that the implant offers a "truly sustained treatment option that only requires action once a year"[1].

Clinical Benefits

The profound hormone suppression and the lack of breakthroughs with SUPPRELIN LA are critical clinical benefits. These outcomes not only manage the physical aspects of CPP but also address the psychological and social challenges associated with early puberty[1].

Conclusion

SUPPRELIN LA is a crucial treatment in the management of central precocious puberty, with a strong market presence and positive financial trajectory. The drug's efficacy, convenience, and the growing demand for CPP treatments drive its market growth. However, the high cost of treatment remains a challenge that needs to be addressed through copay assistance programs and policy reforms.

Key Takeaways

• SUPPRELIN LA demonstrates continued profound hormone suppression with no breakthroughs in CPP treatment.
• The Europe CPP treatment market is projected to grow to USD 857.65 million by 2030.
• Key drivers include increasing product launches, higher prevalence in girls, and adoption of direct tender segments.
• High treatment costs are a significant restraint.
• Copay assistance programs and policy reforms are crucial for managing costs.
• SUPPRELIN LA's once-yearly administration offers a compliance advantage.

FAQs

What is SUPPRELIN LA used for?

SUPPRELIN LA is used for the treatment of central precocious puberty (CPP), a condition where children enter puberty earlier than usual.

How effective is SUPPRELIN LA in treating CPP?

SUPPRELIN LA has been shown to maintain profound hormone suppression with no breakthroughs, leading to decreased growth velocity, skeletal maturation, and body mass index in children with CPP[1].

What are the key drivers of the CPP treatment market?

The key drivers include increasing product launches, higher prevalence of CPP in girls, and the adoption of direct tender segments[4].

How does the SUPPRELIN LA SHARES Copay Assistance Program help patients?

The program allows eligible patients to save up to $6,000, making the treatment more accessible by reducing the financial burden[2].

What are the projected revenue trends for the CPP treatment market?

The market is projected to grow from USD 510.50 million in 2022 to USD 857.65 million by 2030, at a CAGR of 6.7%[4].

What are the policy implications for prescription drug spending, including SUPPRELIN LA?

Efforts to increase transparency, reduce pay-for-delay deals, and promote biosimilar use are expected to continue, which could impact the pricing and market dynamics of SUPPRELIN LA and similar drugs[3].

Sources

1. Indevus Pharmaceuticals, Inc. - "Two Year Study Confirms SUPPRELIN LA Implant Maintains Profound Hormone Suppression in Children with Central Precocious Puberty" - BioSpace.
2. SUPPRELIN® LA - "SHARES Copay Assistance Program" - SUPPRELIN LA.
3. Conti RM et al. - "Projections of US Prescription Drug Spending and Key Policy Implications" - JAMA Health Forum.
4. Data Bridge Market Research - "Europe Central Precocious Puberty (CPP) Treatment Market" - Data Bridge Market Research.