Healthcare company Organon (NYSE:OGN) said on Monday that it has entered into an agreement to exclusively license global rights to MIUDELLA, Sebela Pharmaceuticals' hormone-free copper intrauterine device (IUD).

The transaction is subject to Hart-Scott-Rodino review and US Food and Drug Administration (FDA) approval of alternate supply chain entities.

MIUDELLA, the first hormone-free copper IUD approved in the United States in 40 years, received FDA approval in February 2025 for up to three years of pregnancy prevention but is not yet commercially available. The device features a flexible frame and a preloaded inserter with a 3.7mm tapered insertion tube.

Under the deal, Organon will pay USD27.5m at closing, with potential sales-based milestone payments of up to USD505m and tiered double-digit royalties on net sales.