Surprise! Mylan's Copaxone Generic Sets Teva Up For A Struggle
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."
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Teva announced the appointment of former Sandoz CEO Richard Francis as its next leader as Kare Schultz steps down.
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 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.