Organon has completed a global licensing agreement with Sebela Pharmaceuticals for exclusive rights to MIUDELLA, a hormone-free copper intrauterine device. Approved by the US FDA in February 2025, MIUDELLA is the first hormone-free copper IUD introduced in the US in over 40 years and is 99% effective for pregnancy prevention for up to three years. The device features a proprietary flexible frame and a preloaded inserter with a 3.7mm diameter tube. Commercial availability is anticipated in late 2026, with distribution restricted through a Risk Evaluation and Mitigation Strategy program to ensure proper insertion training. The deal strengthens Organon's contraception portfolio and expands long-acting reversible options for women.
Organon & CoOrganon gains exclusive global rights to MIUDELLA, a novel hormone-free IUD, expanding its contraception portfolio and long-acting reversible options.
Sebela Pharmaceuticals licenses MIUDELLA globally to Organon, likely receiving upfront and milestone payments, monetizing its FDA-approved product.