PARSIPPANY, N.J. (AP) – The Medicines Co. said it has reached a settlement with another drugmaker over future sales of a generic version of its anti-clotting drug Angiomax.

The Parsippany, N.J., company said APP Pharmaceuticals LLC will be allowed to launch a generic version labeled bivalirudin on May 1, 2019, but this license could start before then under certain circumstances. APP also has agreed to make Angiomax for The Medicines Co., giving it another supply source for additional growth, which helps replace a contract manufacturing source it lost recently.

APP, a unit of Fresenius Kabai Co., also agreed to license and supply Medicines Co. with a portfolio of generic products in areas like the treatment of acute cardiovascular, neurological and infectious diseases in hospitals.

APP had applied in 2007 to the Food and Drug Administration to make a generic version of Angiomax, which the FDA approved in 2000. The Medicines Co. responded with a lawsuit alleging a violation of its patents protecting the drug, which expire in 2028. The Medicines Co. said pending litigation will be resolved once APP dismisses an appeal of a federal court decision that a Medicines Co. patent extension application was filed in a timely fashion.

The settlement is subject to review by the Federal Trade Commission and the U.S. Department of Justice.

In October, Teva Pharmaceutical Industries Ltd., the world’s largest maker of generic drugs, also said it will start selling a generic version of Angiomax in 2019, following the settlement of a patent lawsuit.

Date: January 23, 2012
Source: Associated Press