Barr and Bayer sign agreements for launch of generic Yasmin and Yaz oral contraceptives

Jun 24 2008

Barr Laboratories, Inc. has entered into supply and licensing agreements with Bayer for generic versions of Bayer's Yasmin (drospirenone and ethinyl estradiol) and Yaz (drospirenone and ethinyl estradiol) oral contraceptive products.

Under terms of these agreements, Bayer will supply Barr with the generic products for launch prior to the expiration of the patents protecting these products and Barr will have sole responsibility to market, sell and distribute the products in the U.S. under the Barr Laboratories label.

"We are very pleased to have reached these licensing agreements with Bayer that permit Barr to launch our authorized generic versions of Yasmin and Yaz to patients years before the patents protecting these products are due to expire," said Bruce L. Downey, Barr's Chairman and CEO. "Although Bayer will continue to appeal the March 3, 2008 decision by U.S. District Court for the District of New Jersey that found the Yasmin patent invalid, 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."

Under the Yasmin agreement, Bayer will supply Barr with an authorized generic version of Yasmin for launch on or before July 1, 2008 -- several years earlier than the last-to-expire Bayer patent listed in the U.S. Food and Drug Administration's Orange Book. Barr will pay Bayer an undisclosed supply price for the product. Barr also has an additional undisclosed profit split with Gedeon Richter, its development partner for generic Yasmin.

Under a separate agreement, Bayer will supply Barr with an authorized generic version of Yaz for launch on July 1, 2011, or earlier in certain circumstances. Barr will pay Bayer an undisclosed supply price for the product. Barr also has an additional undisclosed profit split with Gedeon Richter, its development partner for generic Yaz.

On March 3, 2008 Barr announced that the U.S. District Court for the District of New Jersey had ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of the patent listed by Bayer's Yasmin product. On April 1, 2008, Bayer appealed this ruling to the U.S. Court of Appeals for the Federal Circuit. Under the licensing agreements, Barr will continue to be able to sell generic versions of Yasmin and Yaz regardless of the outcome of Bayer's appeal.

Yasmin provides an oral contraceptive regimen consisting of 21 active tablets each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol and 7 inert tablets. Yasmin is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. The product had annual U.S. sales of approximately $575 million for the twelve months ended April 2008, based on IMS sales data.

Yaz provides an oral contraceptive regimen consisting of 24 active tablets each containing 3 mg of drospirenone and 0.02 mg of ethinyl estradiol and 4 inert tablets. Yaz is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. The product had annual U.S. sales of approximately $384 million for the twelve months ended April 2008, based on IMS sales data.