Teva went public with a generic version of Yaz. The combination oral contraceptive (COC), Gianvi, is made by Teva Pharmaceutical Industries. On Thursday Teva admitted before a federal court to making false statements about the generic oral contraceptive (drospirenone and ethinyl estradiol). The admission came in a lawsuit filed in federal court by Bayer HealthCare Pharmaceutical, the US distributor of Yaz.
Bayer had sued Teva in the U.S. District Court for the Northern District of Illinois for false advertising and patent infringement, accusing the world’s largest generic drug maker of falsely claiming in Gianvi’s prescribing information that the ethinyl estradiol uses the chemical beta-cyclodextrin as a “clathrate” to stablize it and prolong its shelf life, a patented Bayer technology. In its lawsuit, Bayer said an analysis of Gianvi found it did not use beta-cyclodextrin as a clathrate.
Teva said it would rectify the situation by sending weekly e-mails and faxes to pharmacists throughout the United States for three months that contain corrected prescribing information and had already provided the corrected information to the Food and Drug Administration. It also agreed not to ship any more Gianvi products containing any material claiming that the drug uses beta-cyclodextrin as a clathrate.
Teva received FDA approval for its version of the drug on June 1. Yaz had $782 million in sales in 2009, according to IMS Health.
Teva jumped into the generic Yaz market this month, no doubt in a big hurry to rake in some profits off Yaz before it loses the ability to do so because of the rash of injuries and deaths being attributed to the drug.
Personally I find it highly ironic that Bayer would criticize Teva for making false claims about Yaz. Bayer's reckless failure to disclose the harm its Yaz and Yasmin cause to women is the real crime.
If you or a loved one have been harmed by Yaz, Yasmin, Ocella or, now, Gianvi, please contact an experienced attorney. You can reach us by toll free at 1-888-8419623 during normal business hours or directly by email to Pamela@toledolaw.com.