FDA Extends Exclusivity for Ruconest

The FDA has extended exclusivity for Ruconest, barring the marketing of biosimilars of the drug until July 2026.

Dutch drugmaker Pharming Group NV, which makes Ruconest (recombinant C1 esterase inhibitor), and its U.S. distributor, Salix Pharmaceuticals, said last week that the FDA granted the biological 12 years reference product exclusivity.

The FDA approved Ruconest in July 2014 to treat hereditary angioedema, and the drug was launched in November. Ruconest previously had received orphan drug designation, giving it seven years of marketing exclusivity. That exclusivity runs out in 2021. — Jonathon Shacat