Perrigo launches OTC birth control pill nationwide

2024-03-05

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Perrigo has started shipping Opill, the first over-the-counter daily birth control pill in the U.S., to retailers across the country.

The move follows the FDA’s landmark approval last year, allowing Opill to be sold without a prescription for users of all ages. Designed to meet diverse needs, Opill will be offered in one-month and three-month packages, with prices set at $19.99 and $49.99, respectively.

Opill is noted for its efficacy and safety, with an effectiveness rate of 98% when used as directed. The push to OTC aims to address the fact that nearly half of all pregnancies in the U.S. each year are unintended, often due to challenges in accessing traditional prescription-based contraceptives.

Opill was first approved by the FDA in 1973 and marketed by Pfizer as the Rx product Ovrette, until it was discontinued for business reasons in 2005. French drugmaker HRA acquired the rights to Opill in 2015 with the intent to generate the data necessary to support a full Rx-to-OTC switch application and Perrigo grabbed the reigns when it bought HRA Pharma last in 2022.

Perrigo's HRA Pharma applied for an Rx-to-OTC switch for Opill back in July of 2022. Then, in October of the same year, a month before a planned FDA advisory committee meeting, the agency postponed the meeting, as well as delayed the drug's PDUFA date for 90 days. The FDA gave its approval in July 2023.

Perrigo is one of two drugmakers looking to offer an Rx-to-OTC switch for a birth control pill. In 2018, Cadence OTC bought the rights to two estrogen-progesterone combo oral contraceptives, Lo/Ovral and Alesse, from Pfizer. The company is currently focused on finalizing its go-to-market strategy and online consumer questionnaire.

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