NDAORALTABLETPriority Review
Approved
Aug 2013
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
1
Mechanism of Action
HIV-1 antiretroviral agent [see Microbiology ()].
Indications (6)
combination with rilpivirineknown substitutions associated with resistance to either antiretroviral agentcombination with other antiretroviral agents for the treatment of HIV-1 infection in adults (treatment-naïve-experienced)-experienced but INSTI- naïve) aged at least 4 weeksweighing at least 3 kg
Clinical Trials (1)
A Trial Evaluating Maintenance Therapy With Lamivudine (Epivir®) and Dolutegravir (Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple Highly Active Antiretroviral Therapy (HAART) (ANRS 167 Lamidol)
Started Sep 2015
110 enrolled
HIV-1 Infection
Loss of Exclusivity
LOE Date
Jun 8, 2030
51 months away
Patent Expiry
Jun 8, 2030
Patent Records (4)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 8129385 | Oct 5, 2027 | SubstanceProduct | — |
| 8129385*PED | Apr 5, 2028 | — | |
| 9242986 | Dec 8, 2029 | SubstanceProduct | — |
| 9242986*PED | Jun 8, 2030 | — |