The Medicines Company, Sandoz Reach Agreement for Authorized Generic

The Medicines Company has reached an agreement with Sandoz Inc. for the distribution of an authorized generic of Angiomax (bivalirudin) for injection, an anticoagulant, in the United States.

The agreement follows a ruling by the US Court of Appeals for the Federal Circuit Court that ruled against The Medicines Company in its Angiomax (bivalirudin) patent litigation with Hospira, Inc. In its ruling, the Federal Circuit held that US Patent Nos. 7,582,727 (the ‘727 patent) and 7,598,343 (the ‘343 patent) were invalid.

In March 2014, the US District Court of Delaware found that all of the asserted claims of the ‘727 patent and the ‘343 patent covering Angiomax were valid but not infringed by Hospira's abbreviated new drug application products. The Medicines Company appealed the federal district court's claim construction and non-infringement rulings, while Hospira appealed the validity rulings.

Aniomax is indicated in patients undergoing percutaneous coronary intervention (PCI) with provisional use of a glycoprotein IIb/IIIa inhibitor and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome undergoing PCI. In addition, it is also indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty.

In June 2015, The Medicines Company received US Food and Drug Administration approval for its new molecular entity, Kengreal (cangrelor) as an adjunctive therapy to PCI for reducing periprocedural thrombotic events in patients who have not been treated with a P2Y12 inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.

Source: The Medicines Company (Sandoz) and The Medicines Company (Hospira)

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