Teva is confident that Copaxone will remain its proprietary
Teva Pharmaceutical intends to file a law suit against Dr Reddy's Laboratories for allegedly infringing the patents of Copaxone (glatiramer acetate) injection 40mg/mL, as per the reports.
Copaxone (glatiramer acetate injection) is for treatment of patients with relapsing forms of multiple sclerosis.
"Teva Pharmaceutical confirms that it has received the first paragraph IV notice for its three-times-a-week Copaxone (R) 40 mg/mL product from Dr Reddy's Laboratories. Teva will continue to vigorously defend its Copaxone intellectual property rights against infringement wherever they are challenged. It 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," the company said in a statement.
The company further mentioned that it is confident Copaxone will remain a proprietary, global market leading product for the reduction in the frequency of relapses in RRMS patients over the product's lifecycle, given the strength of its intellectual property rights.
Copaxone 40mg/Ml is protected by two Orange book patents that expires in 2030.