See the DrugPatentWatch profile for Leucovorin
What companies manufacture Leucovorin?
Several companies are involved in the manufacturing and distribution of Leucovorin, a medication used to counteract the effects of folic acid antagonists and treat certain types of anemia. Key manufacturers and suppliers include West-Ward Pharmaceuticals, Fresenius Kabi, and Teva Pharmaceuticals [1]. These companies produce Leucovorin in various formulations, such as Leucovorin Calcium for injection and oral tablets.
What is Leucovorin used for?
Leucovorin is primarily used as a rescue medication following high-dose methotrexate chemotherapy. Methotrexate is a folic acid antagonist that can cause toxicity. Leucovorin helps to "rescue" healthy cells from the effects of methotrexate by providing them with reduced folate, which they need to function [2]. It is also used in combination with fluorouracil to enhance its efficacy in treating advanced colorectal cancer [2][3]. Additionally, Leucovorin can treat megaloblastic anemia caused by folate deficiency when folic acid alone is not effective [2].
When does Leucovorin patent protection expire?
Information on specific patent expiry dates for Leucovorin is often dynamic and subject to various factors, including new patent filings and litigation. DrugPatentWatch.com tracks patent information for pharmaceuticals. While Leucovorin has been available for a considerable time, understanding the current patent landscape for specific formulations or manufacturing processes would require consulting a specialized resource [4].
How does Leucovorin work?
Leucovorin is a reduced form of folic acid, also known as folinic acid. Unlike folic acid, which requires several enzymatic steps to be converted into its active form (tetrahydrofolate), Leucovorin is already in an active form that cells can readily use. This bypasses the metabolic block caused by methotrexate, allowing healthy cells to synthesize DNA and RNA, thus preventing severe toxicity [2]. In the treatment of colorectal cancer, Leucovorin stabilizes the binding of fluorouracil to thymidylate synthase, an enzyme crucial for DNA synthesis, thereby increasing the cytotoxic effect of fluorouracil on cancer cells [3].
What are the potential side effects of Leucovorin?
Leucovorin is generally well-tolerated. However, potential side effects can occur. These may include allergic reactions, fever, rash, or shortness of breath. Some patients might experience nausea or vomiting. If Leucovorin is administered in combination with fluorouracil, the side effects associated with fluorouracil can also occur, such as diarrhea, nausea, vomiting, stomatitis, and myelosuppression [2].
Are there alternative treatments to Leucovorin?
For its use in methotrexate rescue, Leucovorin is the standard of care. Alternative strategies are not typically employed for this specific purpose due to Leucovorin's established efficacy in preventing methotrexate toxicity. In the context of colorectal cancer treatment, while Leucovorin enhances fluorouracil's action, other chemotherapy regimens exist, and treatment decisions are individualized based on the stage and characteristics of the cancer [3]. For folate deficiency anemia, folic acid is the primary treatment; Leucovorin is reserved for specific cases where folic acid alone is insufficient [2].
How is Leucovorin administered and dosed?
Leucovorin can be administered intravenously, intramuscularly, or orally. The dosage and route of administration depend on the specific indication, such as the dose of methotrexate used or the stage of colorectal cancer being treated. Dosing for methotrexate rescue is carefully calculated based on the patient's methotrexate levels and kidney function. For colorectal cancer, it is typically given in conjunction with fluorouracil according to established protocols [2][3].
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Sources:
[1] U.S. Food & Drug Administration. (n.d.). Drug Search. Retrieved from https://www.accessdata.fda.gov/scripts/drugshortage/drugshortages.cfm
[2] National Cancer Institute. (n.d.). Leucovorin Calcium. Retrieved from https://www.cancer.gov/drugdictionary/drug-item/leucovorin-calcium
[3] DrugBank. (n.d.). Leucovorin. Retrieved from https://go.drugbank.com/drugs/DB00353
[4] DrugPatentWatch.com. (n.d.). Leucovorin Patents. Retrieved from https://www.drugpatentwatch.com/