CliffBio
small molecule

ANDROGEL

TESTOSTERONE

Loss of exclusivityOctober 2026latest FDA-listed patent expiry
CompanyBESINS HEALTHCARE IRELAND LTD

Drug detail

Brand nameANDROGEL
Active ingredientTESTOSTERONE
Strength1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage formGEL
RouteTRANSDERMAL
ModalitySmall molecule
FDA approvalSeptember 2012
Marketing statusRX

Listed patents

PatentExpiresType
8741881October 2026use U-1103
8466138October 2026use U-1103
8466137October 2026use U-1103
8754070October 2026product
8729057October 2026product
8759329October 2026product
8486925October 2026product
8466136October 2026product

More from BESINS HEALTHCARE IRELAND LTD

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.

ANDROGEL patent cliff — loss of exclusivity October 2026 | CliffBio