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competitive generic therapy

Defined in 1 dictionary — U.S. Code

United States Code

21 U.S.C. § 355 — under this section

The term “competitive generic therapy” means a drug—

(AA) that is designated as a competitive generic therapy under section 356h of this title; and

(BB) for which there are no unexpired patents or exclusivities on the list of products described in section 355(j)(7)(A) of this title at the time of submission.