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Watson Barred From Generic Actos Market; Mylan, Teva, Ranbaxy May Enter First

This article was originally published in The Pink Sheet Daily

Executive Summary

Watson sues FDA, challenging the agency’s decision not to approve its ANDA for generic Actos while granting market exclusivity to other ANDA filers. The company planned to launch Aug. 17.

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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.

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