ORLADEYO

Launch

berotralstat hydrochloride

NDAORALPELLETSPriority Review
Approved
Dec 2025
Lifecycle
Launch
Competitive Pressure
0/100

Mechanism of Action

activity. Plasma kallikrein is a protease that cleaves high-molecular-weight kininogen (HMWK) to generate cleaved HMWK (cHMWK) and bradykinin, a potent vasodilator that increases vascular permeability resulting in swelling and pain associated with HAE. In patients with HAE due to C1-inhibitor…

Loss of Exclusivity

LOE Date
Nov 1, 2039
166 months away
Patent Expiry
Nov 1, 2039
Exclusivity Expiry
Jun 11, 2029

Patent Records (4)

Patent #ExpiryTypeUse Code
12545645
Nov 1, 2039
SubstanceProduct
12545646
Nov 1, 2039
SubstanceProduct
12545647
Nov 1, 2039
SubstanceProduct
12552750
Nov 1, 2039
SubstanceProduct