Sunday, August 5, 2012

Sandoz launches under 180-days exclusivity generic copies of Dovonex Cream in the US

Sandoz, which had the first-to-file status for calcipotriene cream (LEO Pharma Inc.’s Dovonex® Cream, 0.005%), has launched  the first generic version  in the US.  Calcipotriene cream is indicated for the treatment of plaque psoriasis. 
Sandoz’s is the largest among generic companies in dermatology space both in the US and globally. According to IMS Health, US sales for the branded version of calcipotriene cream were approximately $118.8 million for the 12 months ending in May 2012. 
Currently Sandoz has a total of 172 ANDAs (Abbreviated New Drug Applications) pending approval with the US FDA, including  40 confirmed first-to-file opportunities