FUSILEV Drug Patent Profile

Which patents cover Fusilev, and what generic alternatives are available?

Fusilev is a drug marketed by Acrotech Biopharma and is included in one NDA.

The generic ingredient in FUSILEV is levoleucovorin calcium. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fusilev

A generic version of FUSILEV was approved as levoleucovorin calcium by SANDOZ on March 9^th, 2015.

Summary for FUSILEV

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	5
Patent Applications:	1
Drug Prices:	Drug price information for FUSILEV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FUSILEV
What excipients (inactive ingredients) are in FUSILEV?	FUSILEV excipients list
DailyMed Link:	FUSILEV at DailyMed

See drug prices for FUSILEV

Recent Clinical Trials for FUSILEV

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Academic and Community Cancer Research United	Phase 1/Phase 2
National Cancer Institute (NCI)	Phase 1/Phase 2
National Cancer Institute (NCI)	Phase 3

See all FUSILEV clinical trials

Paragraph IV (Patent) Challenges for FUSILEV

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FUSILEV	Injection	levoleucovorin calcium	50 mg/vial	020140	1	2013-12-19
FUSILEV	Injection	levoleucovorin calcium	10 mg/mL, 17.5 mL vial and 25 mL vial	020140	1	2011-10-26

US Patents and Regulatory Information for FUSILEV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	POWDER;INTRAVENOUS	020140-001	Mar 7, 2008		DISCN	Yes	No
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-002	Apr 29, 2011		DISCN	Yes	No
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-003	Apr 29, 2011		DISCN	Yes	No

Expired US Patents for FUSILEV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	POWDER;INTRAVENOUS	020140-001	Mar 7, 2008
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-003	Apr 29, 2011
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-002	Apr 29, 2011

International Patents for FUSILEV

See the table below for patents covering FUSILEV around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2189782
Japan	H11106342	COMPOSITION OBTAINED BY USING OPTICALLY ACTIVE COMPOUND
Austria	230746
South Africa	8706562
Japan	2844532
European Patent Office	1275393	Composition pharmaceutique contenant un dérivé de ptéridine (Pharmaceutical formulation containing pteridine derivative)

Market Dynamics and Financial Trajectory for FUSILEV (Levoleucovorin)

Last updated: July 30, 2025

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Introduction

FUSILEV, the brand name for Levoleucovorin, is a chemoprotective and supportive agent primarily employed to enhance the efficacy of chemotherapy protocols. As a sterile, lyophilized formulation of the l-isomer of leucovorin, FUSILEV plays a critical role in oncology treatment regimens, notably in mitigating toxicity during high-dose methotrexate therapy and in boosting the effects of certain chemotherapeutic agents. Understanding its market dynamics and financial outlook is vital for stakeholders, including pharmaceutical companies, investors, and healthcare providers, seeking to navigate this niche yet impactful therapeutic.

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Product Profile and Clinical Utility

Levoleucovorin, the active stereoisomer of leucovorin, provides a more targeted mechanism in folate metabolism support, translating to enhanced therapeutic benefits over racemic forms. FUSILEV (Levoleucovorin) is indicated for:

• Rescue therapy after high-dose methotrexate treatment.
• Supplementation to potentiate fluorouracil-based chemotherapy in colorectal cancer.
• Adjunct in the treatment of certain anemias and as a Differentiation agent.

The drug’s efficacy stems from its ability to bypass folate antagonism, thereby protecting normal cells and potentiating chemotherapeutic effects.

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Market Dynamics

1. Growing Oncology Therapies and Precision Medicine

The global rise in cancer incidence, projected to reach an estimated 28.4 million new cases annually by 2040 (per WHO data), fuels increased demand for supportive agents like FUSILEV. Its role in high-dose chemotherapy protocols makes it integral in expanding cancer treatment options across diverse populations.

Furthermore, advances in personalized medicine and targeted therapy increase reliance on supportive medications such as FUSILEV, facilitating optimal dosing and reducing adverse effects, thus fostering sustained demand.

2. Regulatory Approvals and Market Penetration

Key regulatory milestones, such as the FDA’s approval of FUSILEV for specific indications, have historically expanded its market presence. Its inclusion in clinical guidelines for methotrexate overdose management bolsters credibility, encouraging physicians’ prescribing habits.

However, the market remains influenced by regional regulatory environments, with developed markets (U.S., Europe, Japan) demonstrating higher adoption levels compared to emerging regions, where healthcare infrastructure and awareness lag.

3. Competitive Landscape

FUSILEV's primary competition includes alternative folate agents like racemic leucovorin and generic formulations offering cost advantages. Patent exclusivity periods, although limited, have allowed organizations like Spectrum Pharmaceuticals (once involved with FUSILEV) to maintain market share temporarily, but the landscape is increasingly commoditized.

Manufacturers face pricing pressures stemming from generic entrants, demanding differentiation through manufacturing quality, supply reliability, and clinical evidence.

4. Pricing and Reimbursement

Pricing strategies are pivotal, with institutional procurement contracts and reimbursement policies influencing sales dynamics. In markets with robust insurance coverage and national formularies, FUSILEV enjoys favorable reimbursement trajectories. Conversely, in fragmented or cost-sensitive markets, price competition constrains profitability.

5. Impact of Biosimilars and Generic Products

The advent of biosimilars and generics has led to significant price erosion in the supportive care segment. While biosimilars for folate agents are emerging, their impact on FUSILEV’s market share remains modest due to its specific formulation and clinical positioning.

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Financial Trajectory

1. Revenue Trends

Historical revenue for FUSILEV has shown resilience in mature markets, driven by consistent clinical demand. For instance, prior to patent expiration, branded formulations maintained premium pricing, supporting revenue stability.

Post-generic entry, revenues are likely to decline or stabilize at lower levels, contingent on market penetration of cost-effective alternatives. The segment’s global revenue is estimated in the hundreds of millions USD annually, with North America accounting for the lion’s share.

2. R&D and Pipeline Potential

Compounded by its niche application, R&D investment in FUSILEV-specific formulations is limited. However, adjacent innovations, such as combination therapies and new delivery mechanisms, can influence future sales.

Fusion with personalized oncology treatments offers a pathway for incremental growth. Although no major pipeline breakthroughs are publicly announced as of 2023, ongoing research into folate pathway modulation could indirectly benefit FUSILEV’s market positioning.

3. Market Outlook and Forecasts

Analysts project a moderate compound annual growth rate (CAGR) of approximately 2-4% over the next five years within the global supportive care segment, primarily reflecting market maturity and generic competition pressures.

Emerging markets are expected to catalyze growth, driven by expanding cancer care infrastructure and increasing penetration of supportive therapies. Overall, the financial trajectory remains cautiously optimistic, predicated upon regulatory stability, supply chain robustness, and healthcare reimbursement policies.

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Market Challenges and Opportunities

Challenges:

• Price erosion due to generics and biosimilars.
• Regulatory hurdles in developing countries.
• Limited pipeline innovation specific to FUSILEV.
• Clinical competition from alternative agents with similar efficacy profiles.

Opportunities:

• Expansion into new indications, such as novel folate pathway disorders.
• Strategic partnerships with oncology treatment centers.
• Development of combination formulations for simplified dosing.
• Growing cancer incidence globally, particularly in aging populations.

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Regulatory and Market Considerations

Regulatory authorities increasingly emphasize biosimilar approval pathways, which could affect future market dynamics for FUSILEV. Intellectual property rights, especially exclusivity periods, affect how long the current formulations command premium pricing.

Manufacturers must navigate complex reimbursement landscapes, particularly with government tenders and price-sensitive markets, demanding strategic planning and value demonstration.

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Key Takeaways

• Market demand for FUSILEV remains supported by its critical role in oncology supportive care, particularly in high-dose methotrexate regimens.
• Intensified generic competition and price pressures challenge profitability, especially outside the U.S. and Europe.
• The global rise in cancer incidence and advancements in personalized medicine sustain long-term demand, with emerging markets offering growth potential.
• Despite limited innovation, strategic launches, combination formulations, and expanded indications could offer future revenue opportunities.
• Regulatory landscapes and reimbursement policies are key determinants of market accessibility and financial trajectory.

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FAQs

1. What are the primary drivers of FUSILEV’s market demand?
The core drivers include its essential role in chemotherapy protocols, rising global cancer incidence, and regulatory endorsements for toxicity management.

2. How does generic competition influence FUSILEV’s pricing and sales?
Generics exert downward pressure on prices, reducing profit margins, but volume-based sales may offset some profitability declines in mature markets.

3. What is the outlook for FUSILEV in emerging markets?
Growing healthcare infrastructure and increasing cancer treatment access suggest a promising outlook, though price sensitivity and regulatory hurdles remain challenges.

4. Are there upcoming innovations or pipeline developments related to FUSILEV?
Current pipeline innovations are limited; future prospects depend on combination therapies or new delivery systems leveraging folate pathway insights.

5. How do reimbursement policies impact FUSILEV’s financial performance?
Reimbursement influences patient access and prescribing habits, with favorable policies boosting sales, while restrictive policies limit market potential.

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References

1. World Health Organization. (2020). Cancer Fact Sheet.
2. Oncology Clinical Guidelines Fact Sheet. (2022). American Society of Clinical Oncology.
3. Industry Reports. (2022). Market Outlook for Supportive Care Drugs.
4. FDA Drug Approvals and Labeling Data. (2021).
5. Market Analysis Reports. (2022). Supportive Oncology Drugs - Global Market Size and Forecast.