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AstraZeneca today announced that it has received a decision of Judge Rodney Sippel of the U.S. District Court for the Eastern District of Missouri in litigation titled In Re Metoprolol Succinate Patent Litigation. This case is a consolidation of the company's cases against defendants KV Pharmaceutical Company, Andrx Pharmaceuticals LLC, Andrx Corporation, and Eon Labs Manufacturing, Inc. The decision was issued in response to motions by all parties argued on November 16-17, 2005, regarding the validity, enforceability and infringement of two of the U.S. patents associated with TOPROL-XL® (metoprolol succinate) extended release tablets.
In its decision, the Court found that the patents asserted by AstraZeneca in this litigation -- the compound patent (U.S. Patent Number 5,081,154; ) and the composition patent (U.S. Patent Number 5,001,161) that cover TOPROL-XL® are invalid. The Court also found that the patents asserted by AstraZeneca in the litigation are unenforceable. AstraZeneca 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. Both patents are due to expire on September 17th 2007.
Sales for TOPROL-XL in the US in 2005 were $1,291 million. TOPROL-XL is a registered trademark of the AstraZeneca group of companies.
TOPROL-XL ® (metoprolol succinate) Extended-Release Tablets
TOPROL-XL® is a beta1-selective (cardioselective) adrenoceptor-blocking agent, for oral administration, available as extended-release tablets. TOPROL-XL has been formulated to provide a continuous release of metoprolol for once-daily administration.
Indications for TOPROL-XL® include the treatment of hypertension, alone or in combination with other antihypertensives; the long-term treatment of angina pectoris; and the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.
Toprol-XL® is sold outside the US as Seloken-ZOK®.
18 January 2006
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