Mylan waives exclusive U.S. rights to generic Kaletra

Aimed at increasing supply during the COVID-19 pandemic, Mylan N.V. (MYL -3.9%) has waived its exclusive U.S. distribution rights for a generic version of AbbVie’s (ABBV +2.8%) HIV antiviral combo pill Kaletra (lopinavir/ritonavir).

Its action enables other generic firms to apply for U.S. approval.

It will earn a 180-day period of market exclusivity for being the first to file and (presumably) the first to receive an FDA nod for the tablet formulation (application currently under agency review).

The FDA approved Lannett Company’s (LCI -2.7%) generic oral solution formulation in January 2017.

https://seekingalpha.com/news/3555159-mylan-waives-exclusive-u-s-rights-to-generic-kaletra-shares-down-4