Watson has been accused of patent infringement for trying to introduce its own generic version of Beyaz, a daily birth control pill containing estrogen, the “fourth generation” progestin drosperinone and a folate supplement.
According to the lawsuit over the Beyaz generic equivalent, Bayer claims to hold the exclusive right to the birth control pill until April 17, 2020. Compensatory and punitive damages are being sought against Watson, arguing that the generic drug maker should be hit with fines that are triple the amount of any revenue it may make from selling generic Beyaz.
Bayer obtained approval to market Beyaz in September 2010, adding a folate supplement to their blockbuster birth control pill Yaz, which became available as a generic that same year.
Yaz and Beyaz both combine 0.02 mg of ethinyl estradiol with 3 mg of drospirenone, a newer generation progestin, which was originally introduced in 2001 with Yasmin birth control, which combines 0.03 mg of ethinyl estradiol with the same 3 mg of drospirenone.
Bayer introduced Yaz in 2006, as the company began to face competition from generic Yasmin equivalents.
All of the drospirenone-based birth control pills have been marred by safety concerns in recent years, as studies suggest that the newer progestin may increase the risk of a blood clot, pulmonary embolism, deep vein thrombosis, stroke, heart attack or sudden death.
Bayer currently faces thousands of claims by women who have filed a Yaz lawsuit, Yasmin lawsuit or Beyaz lawsuit that alleges the drug maker failed to adequately research their birth control pills or warn about the risk of potentially life-threatening side effects.
The FDA recently released a report that suggested drospirenone-based birth control pills may increase the risk of blood clots by 75% over older birth control pills. They also doubled the risk of heart attacks and strokes in users who were new to birth control, with some health problems appearing in less than three months after women started to take the pills.