The 505(B)(2) Drug Approval Pathway

The Section 505(b)(2) drug approval pathway has grown dramatically and now annually exceeds the number of new drug approvals, driven by factors including accumulating exclusivities unavailable to generics, expedited programs, user fee funding, pediatric study requirements, and heightened generic market competition. An examination of all 505(b)(2) approvals from 1993 through 2016 suggests the pathway primarily functions to increase competition rather than extend brand-name exclusivity, as evidenced by the predominance of small or generic manufacturers as sponsors and the infrequency with which applicants request or receive non-patent exclusivity.