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 Pharma Ltd, Hainan Poly Pharm, Norvium Bioscience, Novast Labs, 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:	14
Patent Applications:	3,154
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
Seagen Inc.	Phase 3
Eisai Inc.	Phase 3
Merck Sharp & Dohme Corp.	Phase 3

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
Hainan Poly Pharm	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	217314-002	May 22, 2023	AP	RX	No	No
Hainan Poly Pharm	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	217314-001	May 22, 2023	AP	RX	No	No
Actavis Llc	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	POWDER;INTRAVENOUS	206516-001	Feb 13, 2017		DISCN	No	No

Levoleucovorin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Leucovorin and Levoleucovorin

Introduction

Leucovorin and its isomer levoleucovorin are crucial medications in the treatment of cancer, particularly in chemotherapy regimens. These drugs have seen significant market dynamics and financial trajectories, driven by various factors including demand, innovation, and regulatory environments.

Market Growth Drivers

The global market for leucovorin and levoleucovorin is driven by several key factors:

Rising Cancer Prevalence

The increasing incidence of cancer globally is a major driver for the demand of these drugs. In 2020, approximately 19.3 million new cancer cases were recorded, which is expected to drive the demand for cancer treatments, including leucovorin and levoleucovorin[1].

Essential Role in Chemotherapy

Leucovorin and levoleucovorin are essential in enhancing the efficacy of chemotherapy, particularly with 5-fluorouracil (FU) for colorectal cancer. They protect healthy cells from the toxic effects of chemotherapy, making them indispensable in cancer treatment regimens[2][4].

Innovation in Drug Formulation

Pharmaceutical companies have been innovating in drug formulation, developing more stable and effective forms such as extended-release injections and pre-filled syringes. These innovations enhance patient compliance and reduce overall costs, making the drugs more accessible[4].

Financial Trajectory

Revenue and Sales

Levoleucovorin, marketed as FUSILEV by Spectrum Pharmaceuticals, has shown significant revenue growth. In the second quarter of 2014, FUSILEV net sales were $26.6 million, contributing substantially to the company's total product sales of $46.9 million[3].

Cost and Pricing Dynamics

The cost difference between leucovorin and levoleucovorin is substantial. While the Medicare allowable monthly price for generic leucovorin is around $139, levoleucovorin costs approximately $2,475 per month. This cost difference makes levoleucovorin more economically favorable for some healthcare providers, especially when considering the 6% markup allowed by Medicare[2].

Generic Versions and Market Impact

The availability of generic versions of leucovorin has significantly impacted the market. Generic leucovorin is much cheaper and has become a preferred option in many regions, especially in developing countries where affordability is a critical factor. This has fueled market growth and is expected to continue as more generic versions become available[4].

Competitive Landscape

Key Players

The market for leucovorin and levoleucovorin is competitive, with key players including Teva Pharmaceutical Industries Ltd., Mylan N.V., Hikma Pharmaceuticals plc, and Spectrum Pharmaceuticals. These companies have been investing in research and development, strategic partnerships, and expanding their manufacturing capabilities to capture a larger market share[1][5].

Strategic Partnerships and M&A

Companies in this sector are engaging in strategic partnerships, research and development agreements, and mergers and acquisitions to enhance their market position. For example, Hikma Pharmaceuticals has been expanding its sterile injectables capacity and investing in pipeline replenishment to support long-term growth[5].

Regulatory Environment

FDA Approvals and Clinical Trials

The FDA approval of levoleucovorin in 2011 marked a significant milestone. Clinical trials exploring new indications for leucovorin are ongoing, which could expand its therapeutic uses beyond oncology and folate deficiency. Regulatory bodies are also streamlining the approval process for these drugs, facilitating quicker market entry[2][4].

Global Market Expansion

Emerging Markets

The demand for leucovorin and levoleucovorin is increasing in emerging markets due to rising cancer incidence and growing awareness of folate deficiency. Companies are investing in distribution and partnerships in these regions to tap into the growing customer base[4].

Regional Market Dynamics

The market is segmented by region, with North America, Europe, Asia-Pacific, and the Rest of the World being key areas. The US and MENA regions are particularly significant for companies like Hikma Pharmaceuticals, which has a strong presence in these markets[1][5].

Investment Opportunities

R&D and Innovation

Investing in research and development for new drug formulations or novel delivery systems offers a competitive edge. Companies that innovate in terms of efficacy, safety, or ease of use will have substantial opportunities for growth[4].

Generic Manufacturing

With the patent for many leucovorin products expiring, generic versions are expected to play an increasingly important role. Companies entering the generic manufacturing space can capture a significant portion of the market, especially in emerging regions[4].

Market Expansion

Expanding the availability of leucovorin and levoleucovorin in emerging markets presents a lucrative opportunity. Investing in distribution and partnerships in these regions can help companies tap into a growing customer base[4].

Key Takeaways

• The global market for leucovorin and levoleucovorin is driven by the rising prevalence of cancer and the essential role these drugs play in chemotherapy.
• Innovation in drug formulation and the availability of generic versions are key factors in market growth.
• The financial trajectory is marked by significant revenue growth, particularly for levoleucovorin, and substantial cost differences between branded and generic versions.
• Strategic partnerships, M&A, and regulatory approvals are crucial for market expansion.
• Emerging markets offer significant investment opportunities due to growing demand and expanding healthcare infrastructure.

FAQs

Q: What is the primary use of leucovorin and levoleucovorin in medical treatment? A: Leucovorin and levoleucovorin are primarily used to enhance the efficacy of chemotherapy, particularly with 5-fluorouracil (FU) for colorectal cancer, and to manage folate deficiency.

Q: Why is there a significant cost difference between leucovorin and levoleucovorin? A: The cost difference is largely due to the absence of the pharmacologically inactive dextro-isomer in levoleucovorin, which, although not clinically significant, allows for higher pricing and reimbursement rates.

Q: Which companies are key players in the leucovorin and levoleucovorin market? A: Key players include Teva Pharmaceutical Industries Ltd., Mylan N.V., Hikma Pharmaceuticals plc, and Spectrum Pharmaceuticals.

Q: How are regulatory bodies influencing the market for these drugs? A: Regulatory bodies like the FDA and EMA are streamlining the approval process and conducting clinical trials to explore new indications, which helps in quicker market entry and expanded therapeutic uses.

Q: What investment opportunities exist in the leucovorin and levoleucovorin market? A: Investment opportunities include R&D for new drug formulations, generic manufacturing, and expanding distribution in emerging markets.

Cited Sources

1. Global Leucovorin Calcium Market Trends 2021 - OMRGlobal
2. The Leucovorin Shortage: A Tangled Web of Similar Isomers and Huge Cost Differences - Value Based Cancer
3. Spectrum Pharmaceuticals Reports 45% Sales Growth in the Second Quarter - Business Wire
4. Surging Demand for Leucovorin Calcium Injection Drives Pharma Industry Growth - Market Research Intellect
5. BUILDING FOR THE FUTURE - Hikma Pharmaceuticals 2016 Annual Report - Hikma Pharmaceuticals