Mylan Waives Marketing Exclusivity in US for Lopinavir/Ritonavir for COVID-19 Needs

Mylan announced, in its ongoing effort to support patients and public health needs in the current circumstances surrounding the COVID-19 pandemic, the company has voluntarily waived its exclusive rights in the U.S. to distribute its generic version of Kaletra® (lopinavir/ritonavir) antiretroviral 100mg/25mg and 200mg/50mg tablets to help increase the available supply of the product should it prove effective in the treatment of coronavirus. By doing so, Mylan will enable other generic applicants to be eligible for FDA approval of their medicines for patients in the U.S., expanding access in the event that additional clinical studies or other evaluations conclude that the product may be effective in treating COVID-19.

Mylan was the first company to file a substantially complete abbreviated new drug application with the Food and Drug Administration (FDA) to bring 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.

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