Teva launches generic Yaz in USA, breaking deal with Bayer, which says it will sue; Mylan's generic Valtrex OKed by FDA

Teva Pharmaceutical Industries, the world's leading generic drugs company, announced today that it has commercially launched Gianvi (drospirenone and ethinyl estradiol) tablets, the company's copy version of German drug major Bayer's Yaz.

The action is in contravention of a deal entered into in 2008, when, following previous patent battles over the contraceptive product with what is now Teva's subsidiary Barr Pharmaceuticals, Bayer signed a so-called 'pay-for-delay' agreement, whereby the German firm would supply the product to Teva in exchange for royalty payments, thus delaying its losses from cheaper competition. As part of that deal, Teva would not have launched Yaz in the USA before July 2011, unless other generics makers managed to enter the market earlier.

Total sales of Yaz tablets were around $782 million in the USA, for the 12 months ended December 31, 2009, based on IMS sales data. As the first company to file an Abbreviated New Drug Application containing a paragraph IV certification for this product, Teva says it has been awarded a 180-day period of marketing exclusivity.