inadequate generic competition

(2) The term “inadequate generic competition” means, with respect to a drug, there is not more than one approved drugs 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

21 USC § 356h(e)(2)


Scoping language

In this section
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