Mylan voluntarily waives exclusive rights to distribute generic version of Kaletra antiretroviral to aid US COVID-19 efforts
26 March 2020 -

Mylan (NASDAQ: MYL), a global pharmaceutical company, has voluntarily waived its exclusive rights to distribute its generic version of Kaletra (lopinavir/ritonavir) antiretroviral 100mg/25mg and 200mg/50mg tablets in the United States, it was reported on Wednesday.

This move is intended to help increase the available supply of the product should it prove effective in the treatment of coronavirus. It will allow the company to enable other generic applicants to be eligible for FDA approval of their medicines for patients in the United States, expanding access in the event that additional clinical studies or other evaluations conclude that the product may be effective in treating COVID-19.

The company was the first to file a substantially complete abbreviated new drug application with the Food and Drug Administration (FDA) to launch a generic version of this product to market, entitling the company to a 180-day marketing exclusivity period upon final FDA approval, which is pending.