Sales of Yasmin and Yaz Down, Generic Competition Heightens Risks

August 9, 2010, 3:00PM. By Gordon Gibb

Pittsburgh, PAWhile the decline in fortunes of Yasmin birth control—together with concern over Yaz side effects and Yasmin gallbladder problems—was not enough to prevent manufacturer Bayer from enjoying a 6.4 percent year-over-year growth in sales for its second quarter (Q2) of 2010, concerns over safety nonetheless caused sales of the Bayer birth control products to fall considerably. In so doing, the Yasmin/Yaz/Yasminelle franchise lost its previous position at the top of the Bayer portfolio.

According to a July 30 summary of the manufacturer's Q2 results in Global Insight, sales of the Yasmin/Yaz/Yasminelle portfolio were down 11.1 percent from the same time a year ago. The lower demand for the products, and other factors, is causing Bayer to adjust its sales forecasts.

Part of the reason for the fall in sales of the Yasmin pill—and its sister product, Yaz birth control pills, lay with negative publicity with regard to concern over blood clots (thrombosis) and other adverse reactions. Bayer has been required to add information to its product labeling concerning risks for blood clot at the behest of the US Food and Drug Administration (FDA).

Then there are the lawsuits alleging Yaz blood clots and similar concern with its Yasmin counterpart. Global Insight reports that as of the 10th of July there were about 2,700 lawsuits on the books, brought by plaintiffs who allege health problems stemming from the contraceptive products—or by the estates or family members of women who have died.

But there is another factor attacking the performance of Yasmin and Yaz in the market—and a further risk to women concerned about the potential health effects of contraceptives containing drospirenone:

Generic competition.

Teva Pharmaceuticals is reported to have launched a Yasmin/Yaz generic known as 'Gianvi' at the beginning of June. That launch appears to have caught Bayer by surprise, given that Teva—through its subsidiary Barr Pharmaceuticals—had won the right to market a Yasmin/Yaz generic as of July, 2011.

It was reported that Gianvi (drospirenone + ethinyl estradiol) is targeting a global market for oral contraceptives worth US $1.5 billion annually.

The introduction of a Yasmin/Yaz generic could only increase the potential thrombosis risk to women, given the assumed similarity of formulations. In this way, Yasmin blood clot and Yaz side effects could now extend beyond Bayer.