small molecule

BREZTRI AEROSPHERE

BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

Loss of exclusivityOctober 2038latest FDA-listed patent expiry
CompanyASTRAZENECA AB

Drug detail

Brand nameBREZTRI AEROSPHERE
Active ingredientBUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
Strength0.16MG/INH;0.0048MG/INH;0.018MG/INH
Dosage formAEROSOL, METERED
RouteINHALATION
ModalitySmall molecule
FDA approvalApril 2026
Marketing statusRX

Listed patents

PatentExpiresType
11331442October 2038product
11833292October 2038product
8815258March 2031use U-4503
8324266May 2030use U-4503
9463161May 2030product
10716753May 2030product
9415009May 2030use U-4503
8703806May 2030use U-4503
8808713May 2030product

Regulatory exclusivity

CodeExpires
NSApril 2029

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.