Surprise! Mylan's Copaxone Generic Sets Teva Up For A Struggle
Executive Summary
FDA cleared Mylan's generic version of Copaxone 40mg even after management warned investors not to expect action until 2018. Mylan said it will launch "imminently, but Teva said a launch ahead of the pending appeals case would be "at risk."
You may also be interested in...
Viatris Sues Teva In US Over ‘Illegal Copaxone Scheme’
Viatris’ Mylan has accused Teva of creating a perfect ‘playbook’ to delay Mylan’s launch of a generic version of its Copaxone blockbuster and then strangle uptake, something Mylan was vocal about years earlier, in a suit filed in a New Jersey court.
Teva Sues FDA For Excluding Copaxone From BLA Transition
Teva and US FDA disagree over whether Copaxone is a protein. While generics are already on the market, Teva wants to assert process patents against future would-be competitors, which the firm cannot do through the ANDA pathway.
Teva Sues FDA For Excluding Copaxone From BLA Transition; Wants To Use Biosimilar Litigation Process
Teva and US FDA disagree over whether Copaxone is a protein. While generics are already on the market, Teva wants to assert process patents against future would-be competitors, which the firm cannot do through the ANDA pathway.