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Royce Labs seeking court order to allow generic captopril marketing in suit v. Bristol-Myers Squibb.

Executive Summary

ROYCE CAPTOPRIL ANDA APPROVAL HINGES ON COURT RULING in a patent infringement suit brought by Capoten innovator Bristol-Myers Squibb. In an Aug. 11 emergency motion filed in response to Bristol's Aug. 4 suit, Royce Labs asks the Miami federal court to order Royce's captopril ANDA effective immediately. The patent suit brought by Bristol under the Waxman/Hatch Act triggers a 30-month stay of approval on the ANDA that can be lifted only by court order.

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