AstraZeneca last month charged the generic company Andrx for an alleged impending patent infringement of AstraZeneca's Toprol-XL (metoprolol succinate) 50 mg. Toprol-XL pulled in sales of $909 million in the U.S. market last year, half of which were of the 50 mg dosage.
Toprol-XL, a beta-blocker, is indicated for treating hypertension.
A few days after the case filing, Andrx filed an abbreviated new drug application for the drug in question. Andrx stated that it was the first to file the ANDA for Toprol-XL 50 mg and, as such, is entitled to 180 days of market exclusivity when it launches the drug, pending the results of the patent case.
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