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KV Pharmaceutical, Andrx win summary judgment in patent litigation with AstraZeneca
By Lisa Kerner
Erie, Pa., Jan. 18 - KV Pharmaceutical Co. and Andrx Corp. both announced that the companies have received a favorable court ruling on motions for summary judgment in a patent infringement case. The motions were argued in November 2005 before the U.S. District Court for the Eastern District of Missouri.
AstraZeneca's patents were determined to be invalid and unenforceable by the district court. The company can appeal.
The case was filed against KV Pharmaceutical and Andrx by AstraZeneca based on the companies' submission of abbreviated new drug applications to the Food and Drug Administration, according to company news releases. The applications were seeking approval to market generic formulations of Toprol-XL (metoprolol succinate extended-release tablets).
Following the court decision, KV Pharmaceutical believes it has the first-filed abbreviated new drug application pending at the FDA for the 100 mg and 200 mg strengths of Toprol-XL, said a company release. The company also has similar applications on file for the 50mg and 25 mg strengths.
The approval and launch of Andrx's abbreviated new drug applications for the 25mg, 50mg, 100mg and 200mg strengths of its metoprolol succinate extended-release tablets are subject to: the Food and Drug Administration's removal of Andrx's official action indicated status, satisfaction of all other FDA approval requirements, and successful validation and potential future legal proceedings by AstraZeneca.
Andrx believes it also may be entitled to 180 days of market exclusivity on the 50mg strength of generic Toprol-XL.
Andrx develops generic versions of controlled-release, niche and immediate-release pharmaceutical products, including oral contraceptives. The company is based in Fort Lauderdale, Fla.
St. Louis-based KV Pharmaceutical manufactures and markets branded and generic/non-branded prescription pharmaceutical products.
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