small molecule

BREO ELLIPTA

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Loss of exclusivityApril 2031latest FDA-listed patent expiry
CompanyGLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE

Drug detail

Brand nameBREO ELLIPTA
Active ingredientFLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Strength0.1MG/INH;EQ 0.025MG BASE/INH
Dosage formPOWDER
RouteINHALATION
ModalitySmall molecule
FDA approvalMay 2013
Marketing statusRX

Listed patents

PatentExpiresType
8746242*PEDApril 2031
8746242October 2030product
8534281*PEDSeptember 2030
8534281March 2030product
11116721*PEDAugust 2029
11116721February 2029product
8511304*PEDDecember 2027
8511304June 2027product

Regulatory exclusivity

CodeExpires
PEDNovember 2026
NPPMay 2026

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.

BREO ELLIPTA patent cliff — loss of exclusivity April 2031 | CliffBio