Determination of reference product exclusivity

Section 351(k)(9)(A)(iv) of the Public Health Service Act (42 U.S.C. 262(k)(9)(A)(iv)) is amended— (1) by inserting determine any applicable exclusivity period under paragraph (6) or (7), and shall after the Secretary shall; (2) by striking the period at the end and inserting, as follows:; and (3) by adding at the end the following: (I) Exclusivity for first interchangeable biological products (aa) Products licensed on or after the date of enactment With respect to a biological product licensed under this subsection on or after the date of enactment of the Medication Competition Act, the Secretary shall include on the list published under this subparagraph any applicable exclusivity period under paragraph (6), not later than 30 days after the earliest date on which an expiration date of such an exclusivity period can be known pursuant to paragraph (6). (bb) Products licensed before the date of enactment With respect to a biological product licensed under this subsection before the date of enactment of the Medication Competition Act, the Secretary shall include on the list published under this subparagraph any applicable exclusivity period under paragraph (6), not later than 30 days after the later of such date of enactment or the earliest date on which an expiration date of such an exclusivity period can be known pursuant to paragraph (6). (II) Exclusivity for reference products (aa) Products licensed on or after the date of enactment With respect to a biological product licensed under subsection (a) on or after the date of enactment of the Medication Competition Act, the Secretary shall include on the list published under this subparagraph the expiration date of any exclusivity period under paragraph (7), not later than 30 days after licensure of the biological product. (bb) Products licensed before the date of enactment With respect to any biological product licensed under subsection (a) before the date of enactment of the Medication Competition Act, the Secretary shall include on the list published under this subparagraph the expiration date of any exclusivity period under paragraph (7), not later than 2 years after such date of enactment..