long-monopoly drug
Defined in 1 dictionary — U.S. Code
United States Code
42 U.S.C. § 1320f-3 — in this part (2 versions over time)
In this part, subject to subparagraph (B), the term “long-monopoly drug” means, with respect to an initial price applicability year, a selected drug for which at least 16 years have elapsed since the date of approval of such drug under section 355(c) of title 21 or since the date of licensure of such drug under section 262(a) of this title, as applicable.