inadequate generic competition
Defined in 1 place of the United States Code.
The term "inadequate generic competition" means, with respect to a drug, there is not more than one approved drugs 1 on the list of drugs described in section 355(j)(7)(A) of this title (not including drugs on the discontinued section of such list) that is—
(A) the reference listed drug; or
(B) a generic drug with the same reference listed drug as the drug for which designation as a competitive generic therapy is sought.
Source
- 2017–present21 U.S.C. § 356hFood and Drugs · Competitive generic therapies · in this section