biologic

Ruconest

C1 Esterase Inhibitor (Recombinant)

Loss of exclusivityJuly 2026FDA regulatory exclusivity expiry
CompanyPharming Americas BV

Drug detail

Brand nameRuconest
Active ingredientC1 Esterase Inhibitor (Recombinant)
Strength2100IU
Dosage formFor Injection
RouteIntravenous
ModalityBiologic
FDA approvalJuly 2014
Marketing statusRx

Source: FDA Purple Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.

Ruconest patent cliff — loss of exclusivity July 2026 | CliffBio