Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Bayer’s multimillion dollar birth control pill, Yaz, will go head-to-head with generic competition with the introduction of Teva Pharmaceutical Industries’ Gianvi. Teva was awarded a 180-day marketing exclusivity period for Gianvi by the Food and Drug Administration after being the first company to file an Abbreviated New Drug Application (ANDA). Bayer isn’t taking the news lightly. The company says it plans to sue Teva for prematurely launching the new “girl” on the block, which Bayer says they are not legally permitted to do until July 2011.

Bayer has reason to want to protect its territory. Yaz, also known as Yasmin, brought in $782 million in sales in 2009, making it the top oral contraceptive in the nation. However, with popularity comes criticism. Bayer faces more than 1,100 lawsuits from women who allege that Yaz caused them to suffer serious health problems including heart attack, stroke, pulmonary embolism, blood clots, kidney failure, deep vein thrombosis, and gallbladder disease. Some fatalities have also been reported.

Yaz is marketed as an innovative new type of birth control pill containing drospirenone and ethinyl estradiol that not only serves as an effective contraceptive but also a proven treatment for premenstrual dysphoric disorder (PMDD) and severe acne. Drospirenone is a diuretic that can increase potassium levels in the blood and cause heart rhythm disturbances that can lead to blood clots and other serious problems.

The pills’ safety labels include a risk of potentially life threatening events, but women say Bayer downplayed those side effects even though it knew Yaz was just as, if not more, dangerous than other oral contraceptives. It is expected Gianvi will carry the same risks as its brand-name competitor.

Source: Globes

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