small molecule

AXIRON

TESTOSTERONE

Loss of exclusivitySeptember 2027latest FDA-listed patent expiry
CompanyELI LILLY AND CO

Drug detail

Brand nameAXIRON
Active ingredientTESTOSTERONE
Strength30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage formSOLUTION, METERED
RouteTRANSDERMAL
ModalitySmall molecule
FDA approvalNovember 2010
Marketing statusDISCN

Listed patents

PatentExpiresType
8435944September 2027use U-1390
8807861February 2027product
9289586February 2027use U-1390
8419307February 2027use U-1386
9180194June 2026use U-1390
8993520June 2026use U-1390

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.

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