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news.AstraZeneca has entered into a supply and distribution agreement with Par Pharmaceutical to distribute an authorized generic version of its own heart drug, metoprolol succinate, in the US.
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Currently, the authorized generic product will be distributed in the 25mg dosage strength. This agreement does not affect the availability of AstraZeneca’s branded version of metoprolol succinate, Toprol-XL. AstraZeneca will continue to manufacture and make Toprol-XL available in the US.
The decision by AstraZeneca comes after a 25mg version of metoprolol succinate was launched in the US by a generic subsidiary of Novartis. The 25mg dose accounts for an estimated 20% of AstraZeneca’s Toprol-XL sales in the US.
AstraZeneca will take a one-time charge of about $150 million. The company said that it now expects the full year EPS guidance to be at the lower end of the $3.85 to $3.95 range.
A US district court has held the patents covering Toprol-XL extended release tablets to be invalid and unenforceable.
AstraZeneca said that it strongly disagrees with the court’s decision, and filed a notice of appeal in February to the Court of Appeals. A decision regarding this appeal is pending. The patent protecting Toprol-XL expires September 18, 2007.