Organon Completes Agreement to License MIUDELLA®, Sebela Pharmaceuticals’ Hormone-Free Intrauterine Device
This transaction strengthens Organon’s contraception portfolio and expands long-acting reversible options for women
Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced the completion of a global licensing agreement with Sebela Pharmaceuticals, granting Organon exclusive rights to MIUDELLA®, a hormone-free, copper intrauterine device (IUD). Please see our prior announcement for a summary of the transaction terms.
Approved by the US Food and Drug Administration (FDA) on February 24, 2025, MIUDELLA is the first hormone-free copper IUD to be introduced in the US in over 40 years. Indicated for the prevention of pregnancy for up to three years in females of reproductive potential, MIUDELLA is 99% effective. It features a proprietary SLIMSERTTM technology, which consists of a highly flexible frame and a fully preloaded inserter with a small, tapered insertion tube diameter of 3.7mm.1
MIUDELLA is anticipated to be commercially available in late 2026. The MIUDELLA label includes a Risk Evaluation and Mitigation Strategy (REMS). A REMS is a strategy used by the FDA to manage known or potential risks associated with a product. To mitigate complications due to potential improper insertion, MIUDELLA will only be available in the US through the MIUDELLA REMS program. See additional safety information below.
