Bayer has entered into a deal with Barr Pharmaceuticals to supply generic versions of the German firm’s big-selling Yasmin and Yaz oral contraceptives, three months after its US patents on the former drug were declared invalid.
The Leverkusen-based firm has acted quickly to deal with the disappointment caused by a New Jersey court’s decision in March to declare the key patent on Yasmin (drospirenone and ethinyl estradiol) invalid. This agreement with Barr, which filed its Abbreviated New Drug application back in January 2005, means that Bayer will supply the US firm with the generic for launch prior to the expiration of the patents on both the products.
The copycat, but authorised, versions of Yasmin and Yaz (also drospirenone and ethinyl estradiol) will now be launched on or before July 1, 2008 and July 1,2011, respectively, several years earlier than the last-to-expire Bayer patent listed in the FDA’s Orange Book. Barr, which has an additional profit split with Gedeon Richter, its development partner for generic Yasmin, will pay Bayer an undisclosed supply price for the products.
Despite this deal, however, Bayer said it would continue to pursue an appeal of the New Jersey decision in March and if successful, it would receive a larger share of Barr’s revenues from generic Yasmin. Commenting on the agreement, Bayer HealthCare board member Gunnar Riemann said that they “allow us to participate in the US market for generic oral contraceptives in partnership with an established player”.
He added that the firm’s global women’s healthcare business should continue posting high-single-digit to low-double-digit percentage annual growth rates in the coming years “thanks to the products we already have on the market and to new, promising developmental products”.
Barr is also pretty happy with the deal and chief executive Bruce Downey said that although Bayer will continue to appeal the New Jersey court decision, “these agreements ensure that we will be able to continue selling our generic versions of Yasmin and Yaz regardless of the outcome of that appeal”.
