small molecule

ASTEPRO

AZELASTINE HYDROCHLORIDE

Loss of exclusivityJune 2028latest FDA-listed patent expiry
CompanyVIATRIS SPECIALTY LLC

Drug detail

Brand nameASTEPRO
Active ingredientAZELASTINE HYDROCHLORIDE
Strength0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage formSPRAY, METERED
RouteNASAL
ModalitySmall molecule
FDA approvalOctober 2008
Marketing statusDISCN

Listed patents

PatentExpiresType
8071073June 2028product

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.

ASTEPRO patent cliff — loss of exclusivity June 2028 | CliffBio