FENSOLVI KIT Drug Patent Profile

When do Fensolvi Kit patents expire, and when can generic versions of Fensolvi Kit launch?

Fensolvi Kit is a drug marketed by Tolmar and is included in one NDA. There are two patents protecting this drug.

This drug has eleven patent family members in eleven countries.

The generic ingredient in FENSOLVI KIT is leuprolide acetate. There are twenty-two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fensolvi Kit

A generic version of FENSOLVI KIT was approved as leuprolide acetate by SANDOZ on August 4^th, 1998.

Summary for FENSOLVI KIT

International Patents:	11
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FENSOLVI KIT
DailyMed Link:	FENSOLVI KIT at DailyMed

Pharmacology for FENSOLVI KIT

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

US Patents and Regulatory Information for FENSOLVI KIT

FENSOLVI KIT is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020		RX	Yes	Yes				Y
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020		RX	Yes	Yes			Y	Y

Expired US Patents for FENSOLVI KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020

International Patents for FENSOLVI KIT

See the table below for patents covering FENSOLVI KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0114069	"composições poliméricas de liberação de leuprolida com eficácia melhorada, processo para preparação das mesmas, implante sólido, kit e uso".
South Korea	100831113
Cyprus	1110653
Japan	6087886
China	101669900

FENSOLVI KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FENSOLVI KIT

Introduction

FENSOLVI, a six-month, subcutaneously administered leuprolide acetate, was approved by the U.S. Food and Drug Administration (FDA) in May 2020 for the treatment of pediatric patients two years of age and older with central precocious puberty (CPP)[5].

Market Need and Competition

Central precocious puberty is a rare disease characterized by the onset of puberty before age eight in girls and before age nine in boys. Leuprolide acetate is the most widely used treatment for CPP, and FENSOLVI enters a market where there was a need for a more convenient and effective treatment option.

Competitive Landscape

Before FENSOLVI's approval, other leuprolide acetate products were available, but they often required more frequent dosing. FENSOLVI's innovative proprietary polymeric gel technology allows for a six-month dosing cycle, which is a significant advantage over existing treatments. This technology forms an in-situ solid after injection, releasing leuprolide acetate in a sustained and controlled manner over time[5].

Regulatory Approval and Clinical Efficacy

FDA Approval

The FDA approval of FENSOLVI was based on data from a multicenter, open-label, single-arm Phase 3 study. The study demonstrated FENSOLVI's clinical efficacy in suppressing sex hormone levels and arresting or reversing the progression of puberty, with a favorable safety and tolerability profile[5].

Clinical Benefits

FENSOLVI offers several clinical benefits, including a small injection volume of 0.375mL, subcutaneous administration, and a twice-yearly dosing cycle. These features are crucial for improving patient compliance, especially in pediatric patients who require treatment for several years[5].

Market Impact and Supply Chain

Addressing Shortages

The approval and availability of FENSOLVI came at a time when there were reports of shortages of other leuprolide acetate injection products in the U.S. market. Tolmar Pharmaceuticals, the manufacturer of FENSOLVI, affirmed its ability to supply the drug and even increased production to meet the demand, ensuring that patients with CPP would not face treatment disruptions[4].

Global Availability

Tolmar has a demonstrated record of providing consistent supply of its leuprolide acetate products globally, across approximately 89 countries, with no shortages reported to date. This global reach and reliable supply chain are critical for maintaining market stability and patient access to the drug[4].

Financial Trajectory

Revenue Potential

Given its unique features and the critical need it fills in the treatment of CPP, FENSOLVI has significant revenue potential. The drug's approval and subsequent market entry have allowed Tolmar Pharmaceuticals to capture a larger market share in the leuprolide acetate segment.

Cost and Pricing

The development and pricing of FENSOLVI are influenced by several factors, including the cost of development, manufacturing, and the competitive landscape. Developing a new medicine typically takes 10-15 years and costs around $2.6 billion, including the costs of failures along the way[3].

Market Share and Competition

The impact of FENSOLVI on the market share of other leuprolide acetate products, such as Lupron, is notable. For instance, during a shortage of Lupron, FENSOLVI was able to capture a larger market share than it otherwise would have, as patients and healthcare providers sought alternative treatments[1].

Patient and Physician Adoption

Patient Compliance

The six-month dosing cycle and small injection volume of FENSOLVI have been well-received by patients and their families. This convenience can improve treatment compliance, which is crucial for the long-term management of CPP[5].

Physician Preference

Physicians appreciate the efficacy, safety, and convenience of FENSOLVI. Dr. Stuart Atkinson, Vice President and Head of Medical Affairs at Tolmar Pharmaceuticals, highlighted the clinical data demonstrating the efficacy and safety of FENSOLVI, which are key factors in physician preference[5].

Challenges and Opportunities

Regulatory Environment

The regulatory environment, particularly the FDA's approval process, plays a significant role in the market dynamics of pharmaceuticals. FENSOLVI's approval under the FDA's stringent guidelines underscores its safety and efficacy, which can enhance market confidence[5].

Competitive Ecosystem

The life sciences industry is highly competitive, with innovative products, emerging therapies, and eventual generic and biosimilar competition. FENSOLVI must navigate this ecosystem to maintain its market position[3].

Financial Projections and Performance

Revenue Growth

Given its unique selling points and the addressable market, FENSOLVI is expected to contribute significantly to Tolmar Pharmaceuticals' revenue growth. The company's ability to increase production and ensure a stable supply chain further supports this growth potential.

Cost Management

Effective cost management is crucial for maintaining profitability. Tolmar's state-of-the-art cGMP facilities and efficient manufacturing processes help in controlling costs while ensuring high-quality production[4].

Key Takeaways

• Unique Selling Proposition: FENSOLVI's six-month dosing cycle and innovative polymeric gel technology differentiate it from other leuprolide acetate products.
• Market Need: FENSOLVI addresses a critical need in the treatment of central precocious puberty, particularly during times of shortages of other similar products.
• Regulatory Approval: FDA approval based on robust clinical data ensures the drug's safety and efficacy.
• Financial Trajectory: Significant revenue potential driven by its unique features, reliable supply chain, and strong market adoption.
• Competitive Landscape: FENSOLVI competes in a highly competitive life sciences industry but has carved out a niche with its innovative technology and clinical benefits.

FAQs

Q: What is FENSOLVI used for?

FENSOLVI is used for the treatment of pediatric patients two years of age and older with central precocious puberty (CPP)[5].

Q: How does FENSOLVI differ from other leuprolide acetate products?

FENSOLVI is the only six-month, subcutaneously administered leuprolide acetate approved for CPP, utilizing an innovative proprietary polymeric gel technology for sustained release[5].

Q: What are the clinical benefits of FENSOLVI?

FENSOLVI offers a small injection volume, subcutaneous administration, and a twice-yearly dosing cycle, which improves patient compliance and treatment efficacy[5].

Q: How has FENSOLVI impacted the market share of other leuprolide acetate products?

During a shortage of Lupron, FENSOLVI captured a larger market share than it otherwise would have, as it provided a timely alternative treatment option[1].

Q: What are the financial implications of FENSOLVI's approval for Tolmar Pharmaceuticals?

FENSOLVI is expected to contribute significantly to Tolmar Pharmaceuticals' revenue growth due to its unique features, reliable supply chain, and strong market adoption.

Sources

1. Court of Chancery of the State of Delaware - Opinion on AbbVie vs. Takeda.
2. FDA - FY 2020 PDUFA Performance Report.
3. CBSA - Weekly Policy Blog: CBSA Joins New Partnership to Promote Benefits of Pro-Innovation Mergers and Acquisitions.
4. PR Newswire - Tolmar Affirms Supply of FENSOLVI (leuprolide acetate) for Pediatric Patients with Central Precocious Puberty.
5. BioSpace - FDA Approves FENSOLVI (leuprolide acetate) for Injectable Suspension for Pediatric Patients with Central Precocious Puberty.