Generic form of Spectrum's Fusilev (levoleucovorin calcium) launched in the US for osteosarcoma- Mylan

Mylan announced the US launch of levoleucovorin calcium injection 10 mg (base)/mL; 175 mg (base)/17.5 mL and 250 mg (base)/25 mL single-use vials, which is the generic version of Spectrum Pharmaceuticals' Fusilev for Injection. Mylan received final approval from the FDA for its Abbreviated New Drug Application for this product, which is indicated for rescue use after high-dose methotrexate therapy in osteosarcoma. Levoleucovorin is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.

Comment: The United States Patent and Trademark Office extended Spectrum's patent by more than two years, from December 2019 expiration date to March 2022 and Spectrum then sued Sandoz in 2014 for patent infringement, claiming that Fusilev had additional Orphan Drug law protections extending its patent. However following an appeal, in April 2015 the injunction aimed to block the generic was denied by the appeals court and Sandoz was granted a summary judgment of noninfringement.