Levoleucovorin - Generic Drug Details

What are the generic sources for levoleucovorin and what is the scope of freedom to operate?

Levoleucovorin is the generic ingredient in three 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 fifteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for levoleucovorin. One supplier is listed for this compound.

Summary for levoleucovorin

US Patents:	1
Tradenames:	3
Applicants:	11
NDAs:	15
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	21
Drug Prices:	Drug price trends for levoleucovorin
What excipients (inactive ingredients) are in levoleucovorin?	levoleucovorin excipients list
DailyMed Link:	levoleucovorin at DailyMed

See drug prices for levoleucovorin

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for levoleucovorin

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for levoleucovorin

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

Sponsor	Phase
Daiichi Sankyo	PHASE1
National Cancer Institute (NCI)	PHASE2
Janssen Research & Development, LLC	PHASE3

See all levoleucovorin clinical trials

Pharmacology for levoleucovorin

Drug Class

Folate Analog

US Patents and Regulatory Information for levoleucovorin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Meitheal	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	POWDER;INTRAVENOUS	211003-001	Aug 22, 2019		DISCN	No	No
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-002	Apr 29, 2011		DISCN	Yes	No
Hikma	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	POWDER;INTRAVENOUS	206263-001	Jun 16, 2016		DISCN	No	No
Amneal	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	POWDER;INTRAVENOUS	207547-001	Feb 13, 2017		DISCN	No	No
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-003	Apr 29, 2011		DISCN	Yes	No

Market Dynamics and Financial Trajectory for Levoleucovorin

Last updated: July 30, 2025

Introduction

Levoleucovorin, an enantiomeric variant of leucovorin (folinic acid), has garnered attention within the oncology and chemotherapeutic landscape due to its enhanced pharmacological profile. Its unique stereochemistry offers potential benefits over racemic forms, positioning it as a targeted adjunct in cancer treatment regimens. This report examines the evolving market dynamics and financial trajectory of levoleucovorin, emphasizing factors influencing demand, competitive factors, regulatory environment, and future growth prospects.

Overview of Levoleucovorin

Levoleucovorin, commercially marketed under brand names like Fusilev (Sun Pharmaceutical Industries), functions primarily as a rescue agent for antifolate chemotherapy (e.g., methotrexate) and as an adjunct to enhance the efficacy of various chemotherapeutic agents. Its mechanism involves replenishing folate pools in healthy cells, thereby reducing toxicity and improving treatment outcomes. The amped efficacy and safety profile distinguish it from racemic leucovorin, providing a strategic advantage in tailored oncology therapy.

Market Drivers

1. Rising Oncology Incidence

Cancer prevalence, notably colorectal, ovarian, and pancreatic cancers, directly influences demand for supportive care drugs like levoleucovorin. As incidence rates escalate globally, particularly in aging populations, the need for effective chemotherapy adjuncts intensifies. The Global Cancer Observatory reports an annual increase in cancer diagnoses, stimulating demand for supportive treatments [1].

2. Growing Adoption in Chemotherapy Protocols

Levoleucovorin's role as a folic acid supplement enhances the efficacy of agents such as fluorouracil (5-FU) and methotrexate. Oncologists prefer targeted folate supplementation, which can reduce side effects and improve patient tolerability, further driving its utilization.

3. Regulatory Approvals and Reimbursement Policies

Market expansion hinges on approvals from regulatory agencies such as the U.S. FDA and EMA. Fusilev's FDA approval for colorectal cancer rescue therapy established a significant platform, with subsequent approvals expanding indications. Reimbursement policies in key markets influence prescribing trends, with supportive coverage fostering increased utilization.

4. Strategic Collaborations and Market Penetration

Pharmaceutical companies are engaging in licensing agreements and collaborations to expand global reach. These strategic alliances facilitate market penetration in emerging economies and diversify supply chains, amplifying revenue streams.

Competitive Landscape

1. Key Players

• Sun Pharmaceutical Industries: Market leader with Fusilev, benefiting from established manufacturing and distribution networks.
• Hospira (Pfizer): Previously marketed leucovorin products before facing competition from generic formulations.
• Generic Manufacturers: Entering markets with cost-effective alternatives, impacting pricing and margins.

2. Competition from Racemic Folinic Acid

While racemic leucovorin remains widely used due to cost advantages, the stereoselectivity of levoleucovorin offers clinical advantages that could justify premium pricing and increased adoption in specific settings.

3. Patent and Exclusivity

Levoleucovorin's patents and exclusivity periods influence market dynamics. Expiry of key patents could prompt generic entries, impacting profitability and pricing strategies.

Regulatory and Reimbursement Factors

1. Market Access Challenges

Navigating regulatory pathways across different geographies remains complex. While the U.S. maintains robust approval of Fusilev, emerging markets may require additional clinical data and local regulatory engagement.

2. Pricing and Reimbursement Policies

Pricing strategies depend heavily on reimbursement decisions. Favorable policies in the U.S. and Europe support sustainable margins, whereas price sensitivity in emerging economies necessitates strategic adjustments.

Financial Trajectory and Forecast

1. Revenue Trends

Levoleucovorin recently generated annual revenues in the range of $250–300 million globally, with growth driven by increased cancer diagnoses and expanded indications [2]. The product's market share benefits from atomized distribution and increasing acceptance within regimens involving 5-FU and methotrexate.

2. Growth Projections

Analysts project a compound annual growth rate (CAGR) of approximately 4–6% over the next five years, driven primarily by:

• Increased adoption in chemotherapy regimens.
• Expansion into emerging markets.
• Development of novel indications and formulations.

3. Impact of Generic Competition

The imminent expiration of key patents may introduce generic formulations, exerting downward pressure on prices. However, differentiated clinical benefits could sustain premium pricing for branded versions, mitigating some margin erosion.

4. Investment in Research and Development

Firms investing in novel delivery systems, biosimilars, or combination therapies may influence levoleucovorin's market space, either through co-development partnerships or alternate formulations.

Market Barriers and Risks

• Pricing Pressures: Cost-sensitive healthcare systems may limit reimbursement.
• Clinical Adoption: Variability in clinical guideline updates and physician preferences could impact utilization rates.
• Regulatory Delays: Slow approval processes or changes in regulatory standards may hinder market entry or expansion.
• Supply Chain Challenges: Manufacturing complexities related to stereoselective synthesis could affect supply stability and costs.

Future Outlook

The outlook for levoleucovorin remains cautiously optimistic. Its clinical efficacy, particularly in specific chemotherapy protocols, facilitates continued demand. The gradual decline in priced due to patent expirations will likely be counterbalanced by volume growth and expanded indications. Innovations in drug delivery and combination therapies could open new revenue streams.

Key Takeaways

• Growing Oncology Burden: Rising cancer incidence worldwide bolsters demand for supportive therapies, including levoleucovorin.
• Unique Clinical Edge: Its stereoselective advantages over racemic folinic acid provide competitive differentiation.
• Market Penetration: Widespread regulatory approvals and strategic collaborations favor expansion, especially in emerging markets.
• Competition Dynamics: Patent expiries and generic entries will influence pricing and margins but may be offset by clinical differentiation.
• Investment Outlook: Moderate growth projections suggest sustained profitability, with opportunities arising from new indications and formulations.

FAQs

1. What distinguishes levoleucovorin from racemic leucovorin?
Levoleucovorin is the pure dextro-enantiomer of leucovorin, offering higher potency and potentially fewer side effects compared to racemic formulations, which contain equal parts of both enantiomers.

2. How significant is levoleucovorin in current chemotherapy protocols?
It plays a vital role as a rescue agent for methotrexate toxicity and an adjunct to enhance fluorouracil therapy, especially in colorectal cancer. Its use is supported by clinical guidelines and regulatory approvals.

3. What are the main factors influencing its market growth?
Key drivers include increasing cancer prevalence, adoption in treatment protocols, regulatory approvals, and strategic market expansion. Patent expiries pose competitive challenges.

4. How does competition impact levoleucovorin's market?
Generic entrants and racemic formulations offer lower-cost alternatives, exerting pricing pressure, though clinical advantages of levoleucovorin can sustain market share.

5. What is the outlook for levoleucovorin’s revenue in the next five years?
Projected CAGR of 4–6%, with growth from expanded indications, geographic market expansion, and volume increases, offsetting some impact of price erosion from generics.

References

[1] Globocan 2022: Global Cancer Data. International Agency for Research on Cancer.
[2] Market analyses from IQVIA, EvaluatePharma, and industry reports detailing recent sales and forecast data.

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This comprehensive review aims to equip healthcare and business strategists with critical insights into the levoleucovorin market, supporting informed decision-making in clinical and commercial contexts.