small molecule

APRETUDE

CABOTEGRAVIR

Loss of exclusivitySeptember 2031latest FDA-listed patent expiry
CompanyViiV HealthcareSee this company's full patent-cliff portfolio

Drug detail

Brand nameAPRETUDE
Active ingredientCABOTEGRAVIR
Strength600MG/3ML (200MG/ML)
Dosage formSUSPENSION, EXTENDED RELEASE
RouteINTRAMUSCULAR
ModalitySmall molecule
FDA approvalDecember 2021
Marketing statusRX

Listed patents

PatentExpiresType
12138264September 2031product
11224597September 2031product
8410103February 2031substance, product
10927129April 2026substance, product

Regulatory exclusivity

CodeExpires
NCEJanuary 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.

APRETUDE patent cliff — loss of exclusivity September 2031 | CliffBio