Sec. 101. Change conditions of first generic exclusivity to spur access and competition
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Section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5)(B)(iv) ) is amended— in subclause (I), by striking 180 days after and all that follows through the period at the end and inserting the following: 180 days after the earlier of— the date of the first commercial marketing of the drug (including the commercial marketing of the listed drug) by any first applicant; or the applicable date specified in subclause (III). ; and by adding at the end the following new subclause:
The applicable date specified in this subclause, with respect to an application for a drug described in subclause (I), is the date on which each of the following conditions is first met: The approval of such an application could be made effective, but for the eligibility of a first applicant for 180-day exclusivity under this clause. At least 30 months have passed since the date of submission of an application for the drug by at least one first applicant. Approval of an application for the drug submitted by at least one first applicant is not precluded under clause
(iii). No application for the drug submitted by any first applicant is approved at the time the conditions under items (aa), (bb), and
(cc)are all met, regardless of whether such an application is subsequently approved. .
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Sec. 101
Change conditions of first generic exclusivity to spur access and competition
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