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Re: jmkobers post# 15539

Tuesday, 05/03/2016 7:38:45 PM

Tuesday, May 03, 2016 7:38:45 PM

Post# of 20689
A generic-drug launch is considered “at risk” if there are unexpired patents on the drug and the patent litigation has not yet been settled at the appellate (i.e. CAFC) level. The 40mg-Copaxone litigation certainly won’t have completed the appeal process by Jan 2017, so any launch at that time will be “at risk” unless the parties settle the case.

Bottom line: If NVS/MNTA have FDA approval, they will launch 40mg Glatopa in Jan 2017 regardless of the litigation status, as long as there is no court injunction against launching (which is highly unlikely, IMO).

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