Teva Pharmaceutical Industries Ltd. confirmed that it has received the first paragraph IV notice for its three-times-a-week COPAXONE 40 mg/mL product from Dr. Reddy’s Laboratories Inc.
According to a press release, Teva said it will continue to vigorously defend its COPAXONE intellectual property rights against infringement wherever they are challenged. Teva intends to file a lawsuit for patent infringement against Dr. Reddy’s within the 45-day period provided under the Hatch-Waxman Act. The filing of the lawsuit will trigger a 30-month stay of FDA approval of Dr. Reddy’s ANDA.