FDAnews Drug Daily Bulletin

Jury Awards GSK $235 Million After Teva Added Heart Failure Indication to Generic Coreg

June 28, 2017

A federal jury awarded GlaxoSmithKline $235 million in a suit against Teva, saying the generics manufacturer infringed on GSK’s patent for the cardiovascular drug Coreg when Teva marketed its generic for chronic heart failure as well as high blood pressure.

The approval of Teva’s generic Coreg (carvedilol) in 2007 was a carve-out, or a conditional approval, in which GSK reserved the rights to market the drug for chronic heart failure. In 2011, however, Teva altered its product label to add the indication.

In its decision, filed in the Delaware federal court, the jury rejected Teva’s claim that the patent cited was invalid and awarded GSK $234.1 million in lost profits and said the drugmaker was entitled to an additional $1.4 million in royalties.

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