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Zeneca Sular Waxman/Hatch patent extension would be limited to two years by FDA determination.

Executive Summary

ZENECA SULAR 1,377-DAY PATENT EXTENSION WOULD REQUIRE FDA REDETERMINATION of the regulatory review period for Sular (nisoldipine extended-release) under the Waxman/Hatch Act. In recent comments to the agency, nisoldipine-innovator Bayer requests that FDA reconsider its judgment that the regulatory review period for the calcium channel blocker began in 1981, when Bayer first submitted an IND for immediate-release nisoldipine. FDA's interpretation would limit the Sular patent (#4,154,839) to a two-year patent extension (expiring Nov. 2, 1998) rather than a nearly four-year extension to Aug. 10, 2000, Bayer said in a July 19 letter to the agency.
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