JULUCA

Peak

dolutegravir sodium and rilpivirine hydrochloride

GSK
NDAORALTABLETPriority Review
Approved
Nov 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1

Mechanism of Action

fixed-dose combination of the HIV-1 antiretroviral agents, dolutegravir and rilpivirine [see Microbiology ()].

Clinical Trials (1)

NCT03984838Phase 1Completed

Study to Evaluate Pharmacokinetics, Safety and Tolerability of Dolutegravir and Rilpivirine (JULUCA™) 50 Milligram (mg)/25 mg Tablets in Healthy Subjects of Japanese Descent

Started Jun 2019
16 enrolled
HIV Infections

Loss of Exclusivity

LOE Date
Sep 5, 2038
152 months away
Patent Expiry
Sep 5, 2038

Patent Records (5)

Patent #ExpiryTypeUse Code
8129385
Oct 5, 2027
SubstanceProduct
—
8129385*PED
Apr 5, 2028
—
9242986
Dec 8, 2029
SubstanceProduct
—
9242986*PED
Jun 8, 2030
—
10426780
Jan 24, 2031
SubstanceProduct
U-257
Company
GSK
GSK
LONDON, United Kingdom
695 open jobs
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers