Mylan voluntarily waives marketing exclusivity for generic Kaletra

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Mylan voluntarily waives marketing exclusivity for generic Kaletra

By Sandra Levy - 03/26/2020

Mylan announced the voluntarily waiving of its exclusive rights in the United States to distribute its generic version of Kaletra (lopinavir/ritonavir) antiretroviral in 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 Food and Drug Administration 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.

Mylan was the first company to file a substantially complete abbreviated new drug application with the 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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