Teva to sue Dr Reddy's over Copaxone patent infringement

8 August 2014

Global generics leader Teva Pharmaceutical Industries (NYSE:TEVA) yesterday confirmed that it has received the first paragraph IV notice for its three-times-a-week Copaxone (glatiramer acetate) injection 40mg/mL product from Indian drugmaker Dr Reddy’s Laboratories (NYSE: RDY).

Israel-headquartered Teva says it will continue to vigorously defend its Copaxone intellectual property rights against infringement wherever they are challenged. Teva intends to file a law suit for patent infringement against Dr Reddy’s within the 45 day period provided under the Hatch-Waxman Act. The filing of the law suit will trigger a 30 month stay of Food and Drug Administration approval of Dr Reddy’s Abbreviated New Drug Application.

According to Teva, Copaxone 40mg/mL is protected by two Orange Book patents that expire in 2030. The company says that the drug is leading multiple sclerosis therapy in the USA and globally, and second-quarter 2014 sales amounted to $900 million, a decrease of 12% on the like 2013 period.

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