Danco Mifeprex Patent Extension Will Be Revised After Corcept Objects
Executive Summary
The patent life of Danco Labs/The Population Council's Mifeprex (mifepristone, RU-486) will be shortened following a determination by FDA that the abortifacient IND became "effective" in 1983 rather than 1994
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Mifeprex patent extension
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...
Mifeprex patent extension
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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