Teva Pharmaceutical Industries Ltd. has received the first paragraph IV notice for its three-times-a-week Copaxone (glatiramer acetate) injection 40 mg/mL product from Dr. Reddy's Laboratories, Inc. Teva says 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 abbreviated new drug application. 

Teva says that Copaxone 40 mg/mL is protected by two Orange Book patents that expire in 2030. In January 2014, the FDA approved Teva’s supplemental new drug application for Copaxone 40 mg/mL administered three times a week. The new formulation allows for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of multiple sclerosis (MS). The company also  filed for marketing authorization in the European Union, Canada, Russia, Australia and other markets globally, with approvals expected over the next several months.

The US Orange Book patents covering Copaxone (20 mg) expired in May 2014.

Copaxone, a drug to treat relapsing-remitting multiple sclerosis, is Teva’s top-selling specialty medicine with 2013 sales of $4.328 billion. 

Source Teva Pharmaceutical Industries