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 Pharma Ltd, Hainan Poly Pharm, Norvium Bioscience, Novast Labs, 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:	46
Clinical Trials:	3
Patent Applications:	6,911
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
Autism Speaks	Phase 2
Phoenix Children's Hospital	Phase 2
State University of New York - Downstate Medical Center	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
Meitheal	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	211002-002	Aug 16, 2019		DISCN	No	No
Meitheal	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	211002-001	Aug 16, 2019	AP	RX	No	Yes
Amneal	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	POWDER;INTRAVENOUS	207547-001	Feb 13, 2017		DISCN	No	No
Sandoz	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	203563-001	Mar 9, 2015	AP	RX	No	No
Hainan Poly Pharm	LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	217314-002	May 22, 2023	AP	RX	No	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
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-003	Apr 29, 2011
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-002	Apr 29, 2011

LEVOLEUCOVORIN CALCIUM Market Analysis and Financial Projection Experimental

Levoleucovorin Calcium Market Dynamics and Financial Trajectory

Introduction to Levoleucovorin Calcium

Levoleucovorin calcium, a chemically reduced derivative of folic acid, is a crucial drug in the treatment of various cancers and in rescuing patients from high-dose methotrexate therapy. It is available under brand names such as Fusilev and Khapzory. Here, we delve into the market dynamics and financial trajectory of levoleucovorin calcium.

Market Size and Growth Projections

The global leucovorin calcium market, which includes levoleucovorin calcium, is expected to experience significant growth over the coming years. As of 2023, the market size was valued at USD 23.24 million, and it is projected to reach USD 163.65 million by 2036, registering a Compound Annual Growth Rate (CAGR) of approximately 16.2% during the forecast period of 2024-2036[4].

Key Drivers of Market Growth

Increasing Prevalence of Cancer

One of the primary drivers of the leucovorin calcium market is the rising prevalence of cancer globally. In 2020, around 19.3 million new cancer cases were recorded worldwide, which is expected to drive the demand for cancer treatments, including leucovorin calcium[1][4].

Expanding Healthcare Infrastructure

The growth of the healthcare system, particularly in developed countries, is another significant factor. The North American region, for instance, is anticipated to hold the largest market share due to the presence of major pharmaceutical companies and high healthcare expenditure. In 2020, the national healthcare expenditure in the U.S. grew by 9.7% to USD 4.1 trillion[4].

Specific Indications and Uses

Levoleucovorin calcium is FDA-approved for several critical indications, including rescue after high-dose methotrexate therapy in osteosarcoma, diminishing the toxicity associated with folic acid antagonists, and treatment of metastatic colorectal cancer in combination with fluorouracil. These specific uses contribute to the drug's market demand[5].

Market Segmentation

End Users

The global leucovorin calcium market is segmented by end users into hospitals, retail pharmacies, specialty clinics, and others. The hospital segment is expected to hold the largest market share by 2036, driven by the expansion of the healthcare system and the necessity of prescription-based access to the drug[4].

Geographic Regions

The market is also segmented geographically, with North America anticipated to dominate due to the presence of major pharmaceutical companies and advanced healthcare infrastructure. The Asia Pacific region is also expected to hold a significant market share, driven by geriatric population growth, infrastructural improvements in healthcare, and increased R&D activities[4].

Challenges and Limitations

Drug Interactions and Supply Issues

Despite the growth prospects, the leucovorin calcium market faces several challenges. These include drug interactions, supply problems due to restrictions on the import of raw materials, and increasing product recalls. These issues can impact the availability and reliability of the drug[4].

Regulatory and Safety Considerations

Levoleucovorin calcium has specific limitations of use, such as not being indicated for the treatment of pernicious anemia and megaloblastic anemias secondary to a lack of vitamin B12, due to the risk of neurologic manifestations despite hematologic remission. These regulatory and safety considerations must be carefully managed to ensure the drug's safe and effective use[5].

Financial Trajectory

Revenue Projections

The financial trajectory of the leucovorin calcium market is promising, with significant revenue growth expected. In 2024, the industry size is assessed at USD 26.63 million, and it is projected to reach USD 163.65 million by 2036. This growth is driven by increasing demand, expanding healthcare infrastructure, and the rising prevalence of cancer[4].

Investment Opportunities

The market's growth prospects present several investment opportunities. Companies involved in this market can benefit from the increasing launch prices and the growing awareness about cancer treatments. Additionally, improvements in healthcare infrastructure, especially in developing countries, offer further investment avenues[4].

Clinical and Pharmacological Aspects

Pharmacokinetics

The pharmacokinetics of levoleucovorin calcium are critical in understanding its efficacy. Studies have shown that intravenous administration of leucovorin calcium results in higher area under the curve (AUC) values for the (6R) isomer compared to the biologically active (6S) isomer. Oral administration, however, produces an AUC for the (6S) reduced folates that is approximately twice that of the (6R) isomer[2].

Clinical Uses

Levoleucovorin calcium is used as an antidote to the inhibition of dihydrofolate reductase by methotrexate and in combination with fluorouracil-based chemotherapy regimens. Its FDA-approved indications include rescue after high-dose methotrexate therapy and treatment of metastatic colorectal cancer[5].

Key Takeaways

• The global leucovorin calcium market is expected to grow significantly, driven by the increasing prevalence of cancer and expanding healthcare infrastructure.
• The market is segmented by end users, with hospitals expected to hold the largest share, and geographically, with North America and the Asia Pacific region being key markets.
• Levoleucovorin calcium faces challenges such as drug interactions and supply issues but offers substantial investment opportunities.
• The drug's pharmacokinetics and clinical uses are crucial for its efficacy and market demand.

FAQs

What are the primary indications for levoleucovorin calcium?

Levoleucovorin calcium is indicated for rescue after high-dose methotrexate therapy in osteosarcoma, diminishing the toxicity associated with folic acid antagonists, and treatment of metastatic colorectal cancer in combination with fluorouracil[5].

How is the global leucovorin calcium market expected to grow?

The global leucovorin calcium market is expected to grow at a CAGR of approximately 16.2% from 2024 to 2036, reaching USD 163.65 million by 2036[4].

What are the main challenges facing the leucovorin calcium market?

The market faces challenges such as drug interactions, supply problems due to restrictions on raw materials, and increasing product recalls[4].

Which regions are expected to dominate the leucovorin calcium market?

North America and the Asia Pacific region are anticipated to hold significant market shares due to advanced healthcare infrastructure and growing R&D activities[4].

What is the significance of the pharmacokinetics of levoleucovorin calcium?

The pharmacokinetics of levoleucovorin calcium are crucial as they determine the efficacy of the drug, with intravenous administration producing different AUC values compared to oral administration[2].

Sources

1. Global Leucovorin Calcium Market Trends 2021 - OMRGlobal
2. Clinical pharmacokinetics of high-dose leucovorin calcium after intravenous and oral administration - PubMed
3. Leucovorin Calcium Market 2019: Business overview, Industry Insights, Trends and Top Company Analysis, Forecast by 2026 - MarketersMedia
4. Leucovorin Calcium Market Size, Growth Forecasts 2036 - Research Nester
5. Levoleucovorin (Fusilev and Khapzory) - Medical Clinical Policy Bulletins - Aetna