Barr confirms filing in USA for Yasmin

Just a week after Schering AG of Germany said that it had been notified by the regulatory authority of the approval of a generic form of its second-best-selling product, Yasmin (drospirenone and ethinyl estradiol), by an unnamed company in the USA (Marketletter March 28), Barr Laboratories confirmed that it has initiated a challenge to the patents listed by Berlex Laboratories, the US subsidiary of Schering, on this low-dose, monophasic oral contraceptive which is the first birth control pill to contain the progestin, drospirenone.

Yasmin had annual US sales of approximately $322.0 million for the 12 months ended January 2005, based on IMS sales data quoted by Barr. Schering's full-year 2004 global turnover from the drug was reported as 429.0 million euros ($552.2 million).

Barr filed its Abbreviated New Drug Application containing a paragraph IV certification for a generic Yasmin product with the US Food and Drug Administration in January and received notification of its acceptance for filing in February. Following receipt of the notice, Barr said that it notified Berlex, the New Drug Application holder in the USA, and Schering, the patent owner.