Teva's product is sold as a generic version of Bayer HealthCare's oral contraceptive Yaz. Bayer believes Teva is offering for sale its Gianvi product with Physician Prescribing Information that falsely claims that Gianvi's ethinyl estradiol is "stabilized by betadex as a clathrate." Based on testing of tablets now in the US market, Bayer believes that Teva's Gianvi product does not in fact contain ethinyl estradiol stabilized by betadex as a clathrate. Teva launched Gianvi on June 2.
Bayer is seeking a temporary restraining order and a preliminary injunction to stop Teva from making false claims about its Gianvi product and from infringing Bayer Schering's U.S. Patent No. 5,798,338, which covers offers to sell a drug with an ethinyl estradiol that is stabilized by betadex as a clathrate. Bayer also asks that Teva take action in the US market to correct any erroneous impression persons may have derived concerning the nature, characteristics or qualities of Gianvi.
Total sales of Yaz Tablets were approximately $782 million in the United States, for the 12 months ending Dec. 31, based on IMS sales data.
Bayer currently faces more than 1,100 lawsuits on behalf of women who allege that the drug maker failed to adequately research their birth control pills (Yaz, Yasmin and generic Ocella) or warn about the risk of serious and potentially life-threatening injuries, such as stroke, heart attack, pulmonary embolism, deep vein thrombosis, gallbladder disease and other complications.