Period of market exclusivity for botanical drugs

Section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)(E)) is amended by adding at the end the following: (vi) (I) A botanical drug approved under subsection (b)(1) pursuant to an application submitted after the date of enactment of this clause shall be entitled to a 12-year period during which no application submitted under subsection (b)(2) or (j) that references or relies upon such drug may become effective. (II) In this clause, the term botanical drug means a botanical drug subject to subsection (a), as determined by the Secretary by regulation..