Barr Labs' ANDA for a generic version of Bayer Schering's oral contraceptive Yasmin has been granted final approval by FDA, the firm announced May 9.

The approval comes just over two months after a favorable court ruling for Barr that opened the door for the firm to launch generic drospirenone/ethinyl estradiol.

On March 3, the U.S. District Court for the District of New Jersey found that the patent covering Yasmin was invalid (¹ Also see "Court Finds Bayer’s Yasmin Oral Contraceptive Patent Is Invalid" - Pink Sheet, 4 March, 2008.).

FDA had already tentatively approved the ANDA, which Barr filed in January 2005 with paragraph IV certification.

Sales of Yasmin for the 12 months ended February totaled $575 million, Barr said, citing IMS Health data.

Both Barr and Watson have filed ANDAs with paragraph IV certification for another Bayer contraceptive, Yaz , which contains lower doses of drospirenone and ethinyl estradiol.

- Brooke McManus (b.mcmanus@elsevier.com)

Barr Gets Go-Ahead For Generic Yasmin

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