AstraZeneca's Toprol XL patents ruled invalid in US

Published: 1-Feb-2006
Regulatory


AstraZeneca (AZ) has lost US patent protection on its top-selling cardiovascular drug, Toprol XL (metoprolol succinate), following challenges by Andrx, KV Pharmaceutical and Eon Labs, a unit of Novartis.

A judge in the US District Court for the Eastern District of Missouri ruled the compound patent (5,081,154) and the composition patent (5,001,161) to be invalid, thus opening the door for generic launches and posing a threat to the $1,291m sales generated by the drug in the US in 2005.

'AZ disagrees with and is disappointed by these conclusions. The company maintains that both patents are valid and enforceable and will appeal the Court's decision,' reads a company statement.

The patents were due to expire on 17 September 2007.

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