NDAORALTABLETPriority Review
Approved
Jan 2021
Lifecycle
Peak
Competitive Pressure
8/100
Mechanism of Action
HIV-1 antiretroviral drug [see Microbiology ()] .
Indications (11)
combination with EDURANT (rilpivirine) for short-term treatment of HIV-1 infection in adultsadolescents 12 years of ageolderweighing at least 35 kgno knownsuspected resistance to either cabotegravirrilpivirinecombination with EDURANT (rilpivirine) tablets for short-term treatment of HIV-1 infection in adultsfor useClinical Studies ()] : • oral lead-in to assess the tolerability of cabotegravir prior to administration of cabotegravir extended-release injectable suspensiona component of CABENUVA (cabotegravir extended-release injectable suspension
Loss of Exclusivity
LOE Date
Feb 4, 2031
59 months away
Patent Expiry
Feb 4, 2031
Exclusivity Expiry
Jan 21, 2026