Sec. 808. Incentivizing competitive generic drug development
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Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5) ) is amended— in subparagraph (B), by adding at the end the following: Subject to subparagraph (D)(iv), if the application is for a drug that is the same as a competitive generic therapy for which any first approved applicant has commenced commercial marketing, the application shall be made effective on the date that is 180 days after the date of the first commercial marketing of the competitive generic therapy (including the commercial marketing of the listed drug) by any first approved applicant. The exclusivity period under subclause
(I)shall not apply with respect to a competitive generic therapy that has previously received an exclusivity period under subclause (I). In this clause and subparagraph (D)(iv): The term competitive generic therapy means a drug— that is designated as a competitive generic therapy under section 506H; and for which there are no unexpired patents or exclusivities on the list of products described in section 505(j)(7)(A) at the time of submission. The term first approved applicant means any applicant that has submitted an application that— is for a competitive generic therapy that is approved on the first day on which any application for such competitive generic therapy is approved; is not eligible for a 180-day exclusivity period under clause
(iv)for the drug that is the subject of the application for the competitive generic therapy; and is not for a drug for which all drug versions have forfeited eligibility for a 180-day exclusivity period under clause
(iv)pursuant to subparagraph (D). ; and in subparagraph (D), by adding at the end the following: The 180-day exclusivity period described in subparagraph (B)(v) shall be forfeited by a first approved applicant if the applicant fails to market the competitive generic therapy within 75 days after the date on which the approval of the first approved applicant’s application for the competitive generic therapy is made effective. .
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Sec. 808
Incentivizing competitive generic drug development
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