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renegotiation-eligible drug

Defined in 1 place of the United States Code.

In this section, the term “renegotiation-eligible drug” means a selected drug that is any of the following:

(A) A selected drug for which a new indication is added to the drug.

(B) A selected drug that—

(i) is not an extended-monopoly or a long-monopoly drug; and

(ii) for which there is a change in status to that of an extended-monopoly drug.

(C) A selected drug that—

(i) is not a long-monopoly drug; and

(ii) for which there is a change in status to that of a long-monopoly drug.

(D) A selected drug for which the Secretary determines there has been a material change of any of the factors described in paragraph (1) or (2) of subsection (e).

Source

In this section, the term "renegotiation-eligible drug" means a selected drug that is any of the following:

(A) Addition of new indication

A selected drug for which a new indication is added to the drug.

(B) Change of status to an extended-monopoly drug

A selected drug that—

(i) is not an extended-monopoly or a long-monopoly drug; and

(ii) for which there is a change in status to that of an extended-monopoly drug.

(C) Change of status to a long-monopoly drug

A selected drug that—

(i) is not a long-monopoly drug; and

(ii) for which there is a change in status to that of a long-monopoly drug.

(D) Material changes

A selected drug for which the Secretary determines there has been a material change of any of the factors described in paragraph (1) or (2) of subsection (e).

Source