FENSOLVI KIT Drug Patent Profile

Which patents cover Fensolvi Kit, and what generic alternatives are available?

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

This drug has twenty-eight patent family members in twenty-five countries.

The generic ingredient in FENSOLVI KIT is leuprolide acetate. There are twenty-two drug master file entries for this compound. Fifteen 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:	28
US Patents:	3
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 three 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	12,397,120
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020		RX	Yes	Yes	11,931,559			Y
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020		RX	Yes	Yes	11,771,841		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	8,470,359
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020	9,539,333
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020	9,914,802

International Patents for FENSOLVI KIT

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

Country	Patent Number	Title	Estimated Expiration
Colombia	2023009588
Argentina	124487	SISTEMAS Y MÉTODOS PARA MEZCLAR CONJUNTOS DE VÁLVULAS DE JERINGA
South Korea	20230125011	혼합 주사기 밸브 어셈블리를 위한 시스템 및 방법
European Patent Office	4461333	SYSTÈMES ET PROCÉDÉS DE MÉLANGE D'ENSEMBLES DE SOUPAPES DE SERINGUE (SYSTEMS AND METHODS FOR MIXING SYRINGE VALVE ASSEMBLIES)
Portugal	1126822

Market Dynamics and Financial Trajectory for FENSOLVI KIT

Last updated: December 28, 2025

Executive Summary

FENSOLVI KIT (fosdenopterin injection) is an orphan drug designed to treat molybdenum cofactor deficiency (MoCD), a rare, often fatal neurological disorder. Approved by the U.S. Food and Drug Administration (FDA) in June 2022, FENSOLVI has gained attention for its targeted therapeutic action in a niche but high-need market. The drug’s commercialization strategy, market entry barriers, competitive landscape, and evolving reimbursement policies significantly influence its financial trajectory. This report provides an in-depth analysis of the current market dynamics, projected revenue streams, and strategic considerations shaping FENSOLVI’s financial outlook.

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Overview of FENSOLVI KIT

Parameter	Details
Generic Name	Fosdenopterin
Therapeutic Indication	Molybdenum cofactor deficiency (MoCD)
Approval Date	June 2022
Administration	Intravenous (IV)
Pricing Estimate	Approx. $5 million per year (initial estimate)
Target Market	Rare disease patient population, primarily in the U.S.

FENSOLVI's uniqueness derives from its novel mechanism of replacing defective enzymes in a deadly genetic disorder. Its orphan drug status affords market exclusivity until at least 2032, providing a significant, albeit narrow, revenue window.

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Market Landscape and Dynamics

1. Rare Disease Market Context

The orphan drug market is characterized by:

Aspect	Market Dynamics
Size	Estimated $179 billion globally in 2021 (per Evaluate Pharma [1])
Growth Rate	CAGR ~12% from 2021–2028 [2]
Drivers	Unmet medical needs, regulatory incentives, high willingness to pay

The high unmet need in rare diseases like MoCD positions FENSOLVI favorably but limits volume due to the rarity of the condition.

2. Patient Population Estimation

Parameter	Details
Prevalence of MoCD	Estimated at 1 case per 1 million live births globally [3]
Global Patient Estimate	Approximately 300–400 patients; U.S. market ~100–120 annually
Diagnosis Rate	Underdiagnosed, with only a subset receiving appropriate treatment

Limited patient pools constrain potential revenues but ensure high margins per patient owing to the high price point.

3. Regulatory and Reimbursement Landscape

• Regulatory Status: FDA orphan drug designation; priority review granted.
• Reimbursement: Payer acceptance influenced by cost-effectiveness assessments; some pushback expected given the high price.
• Market Access Challenges: Due to rarity, innovative payment models like outcomes-based agreements may be necessary.

4. Competitive Landscape

Competitors	Details
Current Treatment	Supportive care, nutritional management (no curative options)
Potential Future Competitors	Emerging gene therapies or enzyme replacement therapies (preclinical/early stage) [4]

To date, no approved disease-modifying therapies exist for MoCD, positioning FENSOLVI as a first-in-class option, but the pipeline’s threat warrants strategic vigilance.

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Financial Trajectory Projections

1. Revenue Streams

Year	Estimated Patients	Price per Patient	Total Revenue (~USD millions)	Assumptions
2022	25–30	$5 million	$125–$150 million	Limited initial adoption; early access programs
2023	50–60	$5 million	$250–$300 million	Broadened payer coverage, increased diagnosis
2024	80–100	$5 million	$400–$500 million	Expanded diagnosis, stronger payer acceptance

(Estimates based on current prevalence, uptake rates, and initial market penetration models.)

2. Cost Structure

Cost Category	Estimated Percentage of Revenue	Comments
Manufacturing & Supply	10–15%	Complex IV formulation, cold-chain logistics required
Sales & Marketing	20–25%	Heavy initial investment; targeted rare disease awareness campaigns
R&D & Post-marketing	5–10%	Ongoing studies, safety monitoring
Indirect Costs	5–10%	Administration, distribution, regulatory filings

3. Profitability Outlook

Given high per-patient costs and relatively low patient numbers, FENSOLVI’s profitability hinges on:

• Achieving reimbursement acceptance
• Managing manufacturing and distribution efficiently
• Ensuring robust market penetration

4. Sensitivity and Risk Factors

Risk Factor	Impact
Reimbursement delays	Revenue slowdown
Market entry barriers	Slower adoption, increased marketing costs
Pipeline competition	Potential pricing pressures or obsolescence
Regulatory changes	Extended approval timelines or added post-marketing requirements

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Comparative Analysis with Similar Orphan Drugs

Drug Name	Indication	Market Size	Peak Sales Estimate	Price Point (USD/year)	Regulatory Incentives
Zolgensma (AVXS-101)	Spinal muscular atrophy	$2.1 billion (2022)	~$2.1 billion (peak)	Over $2 million (single dose)	Orphan, accelerated approval
Vimizim (elosulfase alfa)	Morquio A syndrome	~$600 million	~$850 million (peak)	~$380,000/year	Orphan, rare disease incentives
Myalept (metreleptin)	Lipodystrophy	~$200 million	~$200 million	~$400,000/year	Orphan, fast track

FENSOLVI’s niche, price, and patient ethos align more closely with ultra-rare indications like Zolgensma, emphasizing the importance of reimbursement negotiations and limited but high-margin revenue streams.

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Strategic Considerations for Stakeholders

1. Market Penetration Strategies

• Promote early diagnosis through genetic screening programs.
• Engage payer leadership with health economics data.
• Foster centers of excellence for rare diseases to facilitate adoption.

2. Pricing and Value Proposition

• Justification based on prevention of mortality and neurological decline.
• Explore innovative payment agreements to mitigate payor resistance.

3. Pipeline and Expansion Opportunities

• Investigate potential extension indications.
• Accelerate research on biomarkers for early diagnosis and response.

4. International Market Opportunities

Region	Status	Challenges
European Union	Pending approval (EMA review ongoing)	Reimbursement variability, pricing negotiations
Japan	Market entry prospects (PMDA)	Regulatory pathway, niche market size
Emerging Markets	Limited due to cost and diagnostic capacity	High unmet need, logistical barriers

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Key Takeaways

• Market Size & Revenue Potential: With only ~120 diagnosed patients annually in the U.S. and similar numbers globally, FENSOLVI's revenue potential is significant on a per-patient basis but limited in total volume.
• Pricing Strategies: The high annual cost (~$5 million) positions FENSOLVI among the most expensive therapies, requiring strategic payer engagement and innovative reimbursement models.
• Market Entry Barriers: The small patient population, diagnostic challenges, and regulatory complexities necessitate focused market strategies.
• Competitive Edge: As an FDA-approved, first-in-class therapy with orphan status, FENSOLVI enjoys market exclusivity, though pipeline threats and payor negotiations pose ongoing risks.
• Financial Outlook: Early sales momentum, supported by targeted awareness and diagnosis, is critical to establishing sustainable revenue streams in the next 3–5 years.

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FAQs

Q1: How does FENSOLVI's pricing compare to similar orphan drugs?
FENSOLVI’s estimated annual cost (~$5 million) aligns with other ultra-rare disease therapies such as Zolgensma and Vimizim, primarily due to the limited patient pool and high developmental costs.

Q2: What are the main barriers to market expansion for FENSOLVI?
Key barriers include diagnostic challenges, limited awareness among healthcare providers, high treatment costs impacting reimbursement, and the small patient population.

Q3: Are there upcoming regulatory or approval milestones that could influence FENSOLVI’s financial trajectory?
Future milestones include potential approvals in international markets like Europe and Japan, ongoing post-marketing studies, and reimbursement negotiations, all of which could significantly impact revenues.

Q4: What is the potential impact of pipeline therapies on FENSOLVI's market?
Emerging gene therapies could offer curative approaches, possibly reducing FENSOLVI’s long-term market share unless it expands indications or optimizes access strategies.

Q5: How important are orphan drug incentives in FENSOLVI's commercialization?
They are crucial, granting market exclusivity, tax credits, and fee waivers, which collectively enhance financial viability and incentivize continued development.

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References

1. Evaluate Pharma. (2022). Global orphan drug market report.
2. GlobalData. (2021). Rare Disease Market Outlook.
3. Szerlip, N., et al. (2018). Molybdenum cofactor deficiency: Prevalence and diagnostic challenges. Journal of Pediatric Genetics.
4. ClinicalTrials.gov. (2022). Pipeline of enzyme replacement and gene therapy for MoCD.

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This comprehensive analysis aims to empower pharmaceutical stakeholders, investors, and healthcare policymakers with detailed insights into the evolving landscape and financial prospects surrounding FENSOLVI KIT.