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Biocraft's amiloride HCI with hydrocholorthiazide

Executive Summary

ANDA approval announced July 21 for generic version of MS&D's Moduretic. Biocraft says that marketing will be delayed until April 17, 1988. Currently, Biocraft and Merck are in Newark Federal Court disputing the validity of the patent along with Biocraft's application for a generic approval. Both the Merck infringement suit and Biocraft counterclaim cite a patent on the chemical dated Dec. 25, 1973. FDA is using that date to determine the patent expiration: FDA gives the date of patent expiration as Dec. 25, 1990.
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PS012233

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