Leucovorin calcium - Generic Drug Details

What are the generic drug sources for leucovorin calcium and what is the scope of freedom to operate?

Leucovorin calcium is the generic ingredient in three branded drugs marketed by Hospira, Abic, Abraxis Pharm, Elkins Sinn, Hainan Poly, Hikma, Meitheal, Pharmachemie, Pharmachemie Usa, Teva Parenteral, Teva Pharms Usa, Am Regent, Fresenius Kabi Usa, Mylan Labs Ltd, Sagent Pharms, Sagent Pharms Inc, Glaxosmithkline, Novast Labs, Ani Pharms, Barr, Epic Pharma Llc, Leading, Par Pharm, and Xanodyne Pharm, and is included in fifty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for leucovorin calcium. Fourteen suppliers are listed for this compound.

Summary for leucovorin calcium

US Patents:	0
Tradenames:	3
Applicants:	24
NDAs:	53
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	477
Patent Applications:	6,862
Drug Prices:	Drug price trends for leucovorin calcium
What excipients (inactive ingredients) are in leucovorin calcium?	leucovorin calcium excipients list
DailyMed Link:	leucovorin calcium at DailyMed

See drug prices for leucovorin calcium

Recent Clinical Trials for leucovorin calcium

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

Sponsor	Phase
Fudan University	Phase 3
Jonsson Comprehensive Cancer Center	Phase 1/Phase 2
Arcus Biosciences, Inc.	Phase 1/Phase 2

See all leucovorin calcium clinical trials

Pharmacology for leucovorin calcium

Drug Class

Folate Analog

Medical Subject Heading (MeSH) Categories for leucovorin calcium

Antidotes

Vitamin B Complex

US Patents and Regulatory Information for leucovorin calcium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Meitheal	LEUCOVORIN CALCIUM	leucovorin calcium	INJECTABLE;INJECTION	216590-001	Jul 19, 2023	AP	RX	No	No
Novast Labs	LEUCOVORIN CALCIUM	leucovorin calcium	TABLET;ORAL	211132-003	Jul 30, 2020	AB	RX	No	No
Leading	LEUCOVORIN CALCIUM	leucovorin calcium	TABLET;ORAL	213929-001	Oct 22, 2020	AB	RX	No	No
Novast Labs	LEUCOVORIN CALCIUM	leucovorin calcium	TABLET;ORAL	211132-001	Jul 30, 2020	AB	RX	No	No
Hospira	LEUCOVORIN CALCIUM	leucovorin calcium	INJECTABLE;INJECTION	008107-005	Apr 5, 1989		DISCN	Yes	No

Leucovorin calcium Market Analysis and Financial Projection Experimental

Leucovorin Calcium Market Dynamics and Financial Trajectory

Market Size and Growth Forecast

The leucovorin calcium market is poised for 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, growing at a Compound Annual Growth Rate (CAGR) of approximately 16.2% during the forecast period of 2024-2036[1][3][4].

Key Drivers of Growth

Several factors are driving the growth of the leucovorin calcium market:

Increasing Cancer Cases

The global rise in cancer cases, particularly colorectal cancer, is a significant driver. Leucovorin calcium is used in combination with 5-fluorouracil to prolong survival in patients with advanced colorectal cancer[2][4].

Blood Cell Disorders

Growing cases of blood cell disorders such as anemia, thrombocytopenia, and neutropenia, caused by high doses of folic acid antagonists like methotrexate, trimethoprim, and pyrimethamine, are also driving market growth[1][4].

Megaloblastic Anemia

The increasing incidence of megaloblastic anemia due to folic acid deficiency, especially when oral therapy is not feasible, further fuels the market[2][4].

Market Segmentation

End-User Segmentation

The 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 due to the expanding healthcare system and the need for prescription-based purchases. Hospitals are the primary point of care for cancer and critical blood cell disorders, which are key indications for leucovorin calcium[1][4].

Route of Administration

The market is also segmented by the route of administration into oral, injectable, and others. The injectable segment is anticipated to dominate the market by 2036, given that leucovorin calcium is often administered intravenously or intramuscularly, especially in hospital settings[1][2].

Geographical Analysis

North America

North America is expected to hold the largest market share by 2036, driven by the presence of major pharmaceutical companies and advanced healthcare infrastructure. High healthcare expenditure in developed countries, such as the United States, also contributes to this growth. For instance, the national healthcare expenditure in the U.S. grew by 9.7% to USD 4.1 trillion in 2020[1][4].

Asia Pacific

The Asia Pacific region is also anticipated to hold a significant market share due to the growth of the geriatric population, improvements in healthcare infrastructure, and increased research and development activities in countries like China, Japan, and India[1][4].

Challenges and Restraints

Despite the growth prospects, the leucovorin calcium market faces several challenges:

Drug Interactions and Compatibility Issues

Compatibility issues with other drugs like capecitabine and cotrimoxazole, as well as adverse reactions in pregnant and breastfeeding women, and individuals with seizure disorders, can hamper market growth[4].

Supply Chain Disruptions

Supply problems due to restrictions on the import of raw materials into countries like the U.S., China, and India can also impact the market[1].

Key Players and Competitive Landscape

The global leucovorin calcium market is competitive, with several key players:

• Hikma
• Sagent
• Mylan
• Fresenius Kabi
• Teva
• Get Well Pharmaceutical
• RMPL Pharma
• BluePoint Laboratories

These companies are focused on product development, market expansion, and strategic partnerships to maintain their market share[4].

Financial Performance and Outlook

The financial trajectory of the leucovorin calcium market is promising, with significant revenue growth anticipated. Here are some key financial highlights:

• Market Size in 2023: USD 23.24 million[1]
• Projected Market Size by 2036: USD 163.65 million[1]
• CAGR: Approximately 16.2% from 2024 to 2036[1]
• Healthcare Expenditure Impact: High healthcare expenditure in developed regions, such as North America, contributes to market growth[1][4]

Clinical Significance and Usage

Leucovorin calcium is clinically significant in several areas:

Treatment of Megaloblastic Anemia

It is indicated for the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible[2][5].

Combination Therapy for Colorectal Cancer

It is used in combination with 5-fluorouracil to prolong survival in patients with advanced colorectal cancer. Clinical studies have shown improved response rates and survival times with this combination therapy[2].

Rescue Therapy

It is also used as a rescue therapy after high-dose methotrexate therapy in conditions like osteosarcoma and to counteract the effects of folic acid antagonists[2].

Key Takeaways

• The leucovorin calcium market is expected to grow significantly, driven by increasing cancer cases and blood cell disorders.
• The hospital segment and injectable route of administration are anticipated to dominate the market.
• North America and the Asia Pacific region are key geographical markets.
• Major pharmaceutical companies are driving innovation and market expansion.
• Despite growth prospects, the market faces challenges related to drug interactions and supply chain disruptions.

FAQs

Q: What is the primary use of leucovorin calcium in medical treatment? A: Leucovorin calcium is primarily used to treat megaloblastic anemias due to folic acid deficiency, especially when oral therapy is not feasible, and in combination with 5-fluorouracil for advanced colorectal cancer[2][5].

Q: Which segment is expected to hold the largest market share in the leucovorin calcium market by 2036? A: The hospital segment is anticipated to hold the largest market share by 2036 due to the expanding healthcare system and the need for prescription-based purchases[1][4].

Q: What are the key geographical regions driving the growth of the leucovorin calcium market? A: North America and the Asia Pacific region are the key geographical markets driving the growth of the leucovorin calcium market[1][4].

Q: What are some of the challenges facing the leucovorin calcium market? A: The market faces challenges such as drug interactions, compatibility issues, and supply chain disruptions due to restrictions on raw material imports[1][4].

Q: Who are the major players in the global leucovorin calcium market? A: Major players include Hikma, Sagent, Mylan, Fresenius Kabi, Teva, Get Well Pharmaceutical, RMPL Pharma, and BluePoint Laboratories[4].

Cited Sources

1. Research Nester: Leucovorin Calcium Market Size, Growth Forecasts 2036.
2. DailyMed: Leucovorin Calcium For Injection, USP.
3. Growth Plus Reports: Leucovorin Calcium Market Forecast 2031.
4. Verified Market Research: Leucovorin Calcium Market Size, Trends, Opportunities, Share.
5. NPS MedicineWise: DBL Leucovorin Calcium.