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MAJOR CHANGES IN WAXMAN-HATCH BILL

Executive Summary

Brief summaries of the changes made in the ANDA-patent restoration bill in the week prior to adjournment for the GOP Natl. Convention. The changes were described in an Aug. 10 outline of the bill's key provisions. Title I: ANDA The FDA has discretion to request additional safety and efficacy data if there are differences between the active ingredients in the new generic product and the pioneer drug. After enactment, an ANDA may not be filed for five years after the approval of an NDA for a new chemical entity (NCE). ANDAs filed with respect to NDAs approved after enactment, other than those covering NCEs, may not become effective until three years after FDA approval of the NDA. NDAs covering non-NCEs first approved between Jan. 1, 1982 and enactment will receive two years of exclusivity from the date of enactment. Generic copies of patented drugs may be approved when the patent expires or if the generic company can certify that the patent is invalid or will not be infringed. In cases involving a challenge to the validity of a patent, the ANDA approval to market a generic drug may not be made effective until 30 months after litigation commences. Title II: Patent Restoration Only one patent may be extended one time in connection with the approval of the first NDA. The extension is for a maximum of five years with a cap of 14 years on the exclusive marketing period.

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