Israel-based Teva Pharmaceuticals has confirmed that it has received the first paragraph IV notice for its three-times-a-week Copaxone injection 40mg/mL product from Dr Reddys Laboratories.
Dr Reddys had recently filed the first patent challenge against Teva Pharma for Copaxone. The drug generated approximately $4.3 billion in worldwide sales in 2013, accounting for more than 21% of Tevas total revenues. Its US sales were at $3.2 billion in 2013. Worldwide Copaxone revenues edged up 1% to $1.07 billion in the first quarter of 2014. Sales in the US grew 1% to $816 million benefiting from a January price increase.
In a statement, Teva said that 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 Reddys 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 Reddys Abbreviated New Drug Application (ANDA), it said.