Barr Laboratories has confirmed that it is the unnamed company that has filed for US Food and Drug Administration approval of a copycat version of Schering AG’s oral contraceptive, Yasmin (ethinyl estradiol and drospirenone).
The FDA revealed the filing on its website earlier this month [[17/03/05d]], and in a statement, Barr said that it had notified Schering of its move, and that the latter had “indicated that it intends to defend its patents.” No patent challenge has yet been launched. Although Schering has not officially commented on the news, it is unlikely to take the news lying down. Since its US approval and subsequent launch back in 2001, the drug has become a huge success for the German company, bringing in 429 million euros in 2004 revenues – up 56% – which Schering says makes it the world’s leading oral contraceptive [[16/05/01e]], [[09/02/05b]].
Yasmin, which was recently awarded an additional patent covering its formulation in the USA until 2020 [[16/09/04c]], is seen as one of the keys to Schering’s future performance.