competitive generic therapy
Defined in 1 place of the United States Code.
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.
Source
- 2017–present21 U.S.C. § 355Food and Drugs · New drugs · under this section