First OTC Birth Control Pill Approved In US Will Launch With Three-Year Market Exclusivity

FDA approval of Perrigo subsidiary HRA’s application comes 60 years after Rx birth control was approved in the US, one year after the application was submitted, and 13 months after the Supreme Court’s Dobbs ruling. Perrigo plans to launch sales in 2024 first quarter.

Perrigo Company PLC has launched an OTC switch before, but its first with three-year market exclusivity will be Opill, approved as the first nonprescription daily oral contraceptive available in the US.

The Food and Drug Administration's approval announced on 13 July of Perrigo subsidiary HRA Pharma’s supplemental new drug application, 60...