Barr Pharma announced that USFDA has approved the ANDA for generic version of the oral contraceptive Yasmin.
Barr challenged the Yasmin patent held by Bayer AG and in March, a U.S. district court found that the patent held by Bayer was invalid because it was obvious (as reported earlier by this blog). The German drugmaker has appealed the ruling.
Yasmin, known generically as Drospirenone and Ethinyl estradiol, had branded annual sales of about $575 million, Barr said.
The generic drugmaker said it planned to start selling its version of Yasmin in mid 2008. It expects, as the first to file for approval, to have 180 days of exclusivity before any other generic companies can start selling the contraceptive (news link to Reuters & Forbes)
Monday, 12 May 2008
Barr got final approval to market Yasmin (Drospirenone and Ethinyl estradiol)
Posted by ADKS at 11:31 am