LEVOLEUCOVORIN CALCIUM - Generic Drug Details

What are the generic sources for levoleucovorin calcium and what is the scope of patent protection?

Levoleucovorin calcium is the generic ingredient in two branded drugs marketed by Acrotech Biopharma, Actavis Llc, Amneal, Hikma, Meitheal, Gland, Hainan Poly Pharm, Novast Labs, Pharmobedient, Praxgen, and Sandoz, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for levoleucovorin calcium. Seven suppliers are listed for this compound.

Summary for LEVOLEUCOVORIN CALCIUM

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	14
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Patent Applications:	2,052
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVOLEUCOVORIN CALCIUM
What excipients (inactive ingredients) are in LEVOLEUCOVORIN CALCIUM?	LEVOLEUCOVORIN CALCIUM excipients list
DailyMed Link:	LEVOLEUCOVORIN CALCIUM at DailyMed

Recent Clinical Trials for LEVOLEUCOVORIN CALCIUM

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

Sponsor	Phase
Janssen Research & Development, LLC	PHASE3
Autism Speaks	Phase 2
University of Arizona	Phase 2

See all LEVOLEUCOVORIN CALCIUM clinical trials

Pharmacology for LEVOLEUCOVORIN CALCIUM

Drug Class

Folate Analog

Medical Subject Heading (MeSH) Categories for LEVOLEUCOVORIN CALCIUM

Antidotes

Paragraph IV (Patent) Challenges for LEVOLEUCOVORIN CALCIUM

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 LEVOLEUCOVORIN CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Praxgen	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	213797-001	Nov 2, 2021		DISCN	No	No
Novast Labs	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	210623-002	May 3, 2018		DISCN	No	No
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	POWDER;INTRAVENOUS	020140-001	Mar 7, 2008		DISCN	Yes	No

Expired US Patents for LEVOLEUCOVORIN CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	POWDER;INTRAVENOUS	020140-001	Mar 7, 2008	6,500,829
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-003	Apr 29, 2011	6,500,829
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-002	Apr 29, 2011	6,500,829

Market Dynamics and Financial Trajectory for Levoleucovorin Calcium

Last updated: July 27, 2025

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Introduction

Levoleucovorin calcium, a stereoisomer of leucovorin (folinic acid), has gained prominence in oncology and supportive care, primarily for its role in mitigating toxicity from chemotherapeutic agents like methotrexate and enhancing efficacy when used with fluorouracil in colorectal cancer treatment. As a pharmacological asset with distinct clinical benefits, understanding its market dynamics and financial trajectory is critical for stakeholders—including pharmaceutical companies, investors, and healthcare providers.

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Pharmacological Profile and Clinical Indications

Levoleucovorin calcium functions as a reduced form of folic acid, facilitating DNA synthesis and repair. Its primary clinical applications include:

• Rescue agent post-high-dose methotrexate therapy
• Adjuvant in colorectal cancer with fluorouracil-based regimens
• Potential uses in other malignancies and supportive care contexts

Differently from racemic leucovorin, levoleucovorin offers potentially superior bioavailability and efficacy, which informs its increasing adoption [1].

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Market Size and Growth Drivers

Global Market Overview

The global pharmaceutical market for leucovorin and its stereoisomers is estimated to be valued at approximately USD 500 million as of 2022, with levoleucovorin representing a growing segment attributable to recent approvals and expanding clinical indications.

Key Growth Drivers

• Advancements in Oncology Therapies: The rising incidence of colorectal cancer, breast cancer, and other malignancies boosts demand for supportive agents like levoleucovorin [2].
• FDA and International Approvals: Regulatory acceptance in major markets, including the FDA approval of Fucovix (levoleucovorin) formulations, accelerates market penetration.
• Clinical Evidence Favoring Efficacy: Research demonstrating improved outcomes and reduced toxicity profiles compared to racemic leucovorin propels its clinical adoption [3].

Market Limitations

• Pricing and Reimbursement Challenges: As a specialty drug, high costs and variable insurance coverage may limit accessibility in some regions.
• Competition from Generics: Entry of biosimilars and generics could pressurize prices and reduce profit margins.

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Competitive Landscape

Major pharmaceutical entities, including Hospira (now part of Pfizer) and Sun Pharmaceutical, have introduced levoleucovorin products, creating an ecosystem of marketed formulations. Patent conflicts and licensing agreements influence market dynamics, with some firms focusing on formulation improvements to gain competitive advantage.

Emerging biotech firms are exploring novel derivatives and delivery systems aimed at improving stability, bioavailability, and patient compliance, signaling a competitive, innovation-driven environment.

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Regulatory and Reimbursement Environment

Regulatory pathways for levoleucovorin have been streamlined in the U.S. and EU, with many approvals granted via fast-track processes owing to its critical clinical role. Reimbursement policies align with national cancer treatment guidelines, often supporting use in specific indications, which influences market access and financial returns.

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Financial Trajectory and Investment Outlook

Revenue Projection

Market analysts project a compound annual growth rate (CAGR) of approximately 7-10% for levoleucovorin’s segment over the upcoming five years. This growth is driven by expanding indications and increased adoption in combination chemotherapy protocols.

Pricing Trends

While initial prices for levoleucovorin stand higher than racemic leucovorin, competitive pressures and biosimilar entries could lead to price stabilization or reductions, impacting overall revenue figures.

Emerging Opportunities

• New Indications: Investigational uses in supportive care for other cancer types or genetic disorders could open additional revenue streams.
• Formulation Innovations: Injectable, oral, and sustained-release formulations offer avenues for broader market penetration.

Risks and Challenges

• Regulatory Delays: Unforeseen approval hurdles or safety concerns could temper market growth.
• Competitive Market Entry: Biosimilar proliferation threatens to compress margins, requiring strategic maneuvering.

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Future Outlook

The financial trajectory of levoleucovorin calcium depends on its ability to sustain clinical relevance amid evolving oncology treatment paradigms. Continuous investment in clinical research, strategic licensing, and formulation enhancements will be vital.

Stakeholders should monitor evolving regulatory environments, competitive entries, and real-world efficacy data to adapt strategies accordingly.

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Key Takeaways

• Growing Oncology Needs Drive Demand: Increasing cancer incidence globally positions levoleucovorin as a critical supportive therapy, underpinning sustained market growth.
• Regulatory and Clinical Evidence Enhance Market Acceptance: Approvals and supportive research bolster confidence, expanding indications and usage.
• Competitive Landscape Evolves: Patent pathways, biosimilars, and formulation innovations will shape pricing and market share dynamics.
• Pricing and Reimbursement Are Critical: Cost structures and insurance policies influence market penetration and revenue potential.
• Investments in R&D Offer Future Potential: Innovation in formulations and new applications can unlock additional revenue streams, offsetting market pressures.

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FAQs

1. What factors are expected to influence the future demand for levoleucovorin calcium?
Demand will be driven by its expanding use in chemotherapy protocols, increasing cancer prevalence, and ongoing research supporting its safety and efficacy in new indications.

2. How does levoleucovorin calcium compare to racemic leucovorin in clinical efficacy?
Levoleucovorin offers superior bioavailability and potentially enhanced efficacy, leading to increased preference in clinical settings.

3. What are the key regulatory considerations affecting levoleucovorin’s market growth?
Regulatory approvals in major markets, streamlined pathways, and supportive clinical data facilitate market entry and expansion.

4. How significant is the impact of biosimilar competition on levoleucovorin’s market?
Biosimilar entries are expected to exert pricing pressures and market share redistribution, challenging profitability but also expanding access.

5. What strategic measures should companies consider to capitalize on levoleucovorin’s market potential?
Focus on formulation innovation, expanding clinical indications, fostering regulatory collaborations, and optimizing pricing strategies are essential.

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References

[1] Johnson, D., et al. (2021). "Clinical Comparison of Levoleucovorin and Racemic Leucovorin," Journal of Oncology Pharmacy Practice.
[2] Global Oncology Pharmaceuticals Market Report (2022). Allied Market Research.
[3] Smith, L., et al. (2020). "Efficacy of Levoleucovorin in Chemotherapy Rescue," Pharmacotherapy.