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Mifeprex patent extension

Executive Summary

Danco Labs expects Mifeprex (mifepristone, RU-486) to receive a two-year patent extension as a result of FDA's reassessment of the regulatory review period for the abortion drug, in lieu of the four-year extension originally expected. FDA said in an Oct. 24 Federal Register notice that it changed its determination of the start date for the Mifeprex IND from 1994 to the pre-Waxman/Hatch date of 1983 (1"The Pink Sheet" Oct. 28, p. 21). A two-year extension will give Mifeprex exclusivity through January 2004...

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