Bayer has taken another hit on its birth-control pill Yaz. After taking a $500 million charge against 2012 earnings for Yaz and Yasmin-related litigation, the German company has lost its patent fight with three generics makers intent on selling their own copycats.
A U.S. appeals court reversed a lower court ruling that validated Yaz's patent, stopping some generics in their tracks. Now, Actavis ($ACT), formerly Watson Pharmaceuticals, says it will relaunch its copy. Novartis' ($NVS) generics unit Sandoz will continue to ship its version, Reuters says. And India's Lupin says it's finalizing its commercialization plan as it awaits the FDA's final approval.
The Yaz patent in question covered a dosing regimen rather than a drug formula; it was set to expire in 2014. So, Bayer had expected to garner hundreds of millions in additional sales of the branded version in the U.S. The drug's sales in Europe have already been suffering because of generics launched there.
The company's Yaz and Yasmin pills together bring in more than $1 billion a year; Actavis estimates that Yaz and its copies account for $347 million in annual sales. Bloomberg figures that Yaz and related products make up about 2.7% of Bayer's revenue.
Now, Bayer will face generic erosion in the U.S. at the same time it's fighting claims that Yaz and Yasmin caused blood-clot-related injuries. As Bloomberg notes, the company spent €1.19 billion on settlements and legal expenses last year.
- read the Actavis announcement
- see the news from Reuters
- get the Bloomberg article