Teva comments on receipt of first paragraph IV notice for COPAXONE® 40 mg/mL (glatiramer acetate injection) formulation
Posted: 8 August 2014 | | No comments yet
Teva Pharmaceutical Industries Ltd. confirmed that it has received the first paragraph IV notice for its three-times-a-week COPAXONE® 40 mg/mL…
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today 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. Teva 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.
COPAXONE® 40 mg/mL is protected by two Orange Book patents that expire in 2030.