← Patent-cliff monitor Loss of exclusivity May 2040 latest FDA-listed patent expiry
Drug detail Brand name ORLADEYO Active ingredient BEROTRALSTAT DIHYDROCHLORIDE Strength EQ 96MG BASE/PACKET Dosage form PELLETS Route ORAL Modality Small molecule FDA approval December 2025 Marketing status RX
Listed patents Patent Expires Type 12545645*PED May 2040 — 12552750*PED May 2040 — 12545646*PED May 2040 — 12590068*PED May 2040 — 12590069*PED May 2040 — 12545647*PED May 2040 — 12590069 November 2039 substance, product 12344585 November 2039 use U-4535 12545647 November 2039 substance, product 12552750 November 2039 substance, product 12545645 November 2039 substance, product 11618733 November 2039 use U-4535 11117867 November 2039 product 10662160 November 2039 substance 12590068 November 2039 substance, product 12545646 November 2039 substance, product 10125102 April 2035 substance 10329260 March 2035 substance 12116346 March 2035 substance 10689346 March 2035 use U-4535 11230530 March 2035 use U-4535 11708333 March 2035 use U-4535
Regulatory exclusivity Code Expires PED June 2029 NP December 2028
Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.