Teva Pharmaceuticals announced this week that it has launched a generic version of Bayer’s Yaz birth control pill, which will be marketed as Gianvi. The announcement has sparked a patent infringement lawsuit from Bayer, who says Teva is breaking an agreement between the two companies.
The generic Yaz lawsuit was filed shortly after Teva announced the copycat pill. Bayer officials say Teva is violating a contract between the two companies that prohibited the generic drug maker from launching Yaz generic until at least July 2011. Teva officials, however, say that the contract allowed them to sell the generic birth control pill early under certain conditions.
Yaz (ethinyl estradiol and droperinone) is a birth control pill manufactured by Bayer, which contains a fourth-generation progestin that is only found in Yaz, it’s precursor, Yasmin, and Ocella, a generic Yasmin version. While Ocella is also distributed by Teva, Bayer still manufactures the pill under a prior agreement between the drug makers.
Earlier this year, Bayer reported a 10% drop in Yaz sales for the first quarter of 2010 amid growing concerns about the potential side effects of Yaz and Yasmin. The losses in the healthcare division were at odds with gains made in other parts of the company, which saw a 5.3% increase in sales overall for the first quarter of 2010. The successful launch of a Yaz generic would likely cause Bayer’s profits from the birth control pill to fall even further.
“Demand for [the Yaz family of oral contraceptives] in the United States suffered particularly from the discussion surrounding the thrombosis risk of contraceptives containing drospirenone,” the company said in its report. “However, Bayer continues to believe that the risk profile is comparable to that of other combination oral contraceptives.”
Bayer currently faces more than 1,100 Yaz lawsuits, Yasmin lawsuits and generic Ocella lawsuits filed throughout the United States on behalf of women who allege that the drug maker failed to adequately research their birth control pill 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.
Critics have pointed to drospirenone as the likely cause of an increased risk of blood clots and other serious health problems with Yaz and Yasmin. Many of the complaints filed against the drug maker allege that a recall of Yaz and Yasmin should have been issued after post-marketing reports suggested that the birth control pills carry a higher risk than some other oral contraceptives