AstraZeneca signs distribution agreement with Par Pharmaceutical for an authorized generic version of TOPROL-XL
22 November 2006 - AstraZeneca today announced it has entered into a supply and distribution agreement with Par Pharmaceutical to distribute an authorized generic version of metoprolol succinate in the United States. Currently, the authorized generic product will be distributed in the 25 mg dosage strength. The signing of 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 United States.
A 25 mg version of metoprolol succinate was launched in the United States yesterday by Eon Labs, part of Sandoz. The 25 mg dose accounts for an estimated 20 per cent of AstraZeneca’s TOPROL-XL sales in the US.
The Full Year EPS guidance of $3.85 to $3.95 announced with the Third Quarter 2006 results excluded any one-off costs and inventory adjustments associated with the possible launch of generic metoprolol succinate. These one-off costs and inventory adjustments are now calculated to be approximately $150m or 8 cents per share and will be charged in the fourth quarter. After accounting for this, the company now expects the full year EPS guidance to be at the lower end of the $3.85 to $3.95 range previously announced.
On January 17, 2006, a US District Court, in litigation involving KV Pharmaceutical Company, Andrx Pharmaceuticals LLC, Andrx Corporation, and Eon Labs Manufacturing, Inc., held the patents covering TOPROL-XL (metoprolol succinate) extended release tablets to be invalid and unenforceable. AstraZeneca strongly disagrees with the court’s decision, and filed a Notice of Appeal in February to the US Court of Appeals for the Federal Circuit. A decision regarding this appeal is pending. The patent protecting TOPROL-XL expires September 18, 2007.
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