ODEFSEY

Peak

emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide

NDAORALTABLETPriority Review
Approved
Mar 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
12

Mechanism of Action

Nucleoside Reverse Transcriptase Inhibitors

Pharmacologic Class:

Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor

Clinical Trials (5)

NCT03120494Phase 4Unknown

Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part B

Started Nov 2016
75 enrolled
HIV/AIDS
NCT02149888Phase 4Completed

PRe-Exposure Prophylaxis Acceptability & Readiness Assessments for Toronto gaY, Bisexual and Other Men Who Have Sex With Men-5

Started Oct 2014
52 enrolled
HIVHuman Immunodeficiency Virus
NCT01691768Phase 2/3Completed

Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services

Started Oct 2012
372 enrolled
HIV
NCT01488526Phase 4Completed

Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus

Started Mar 2012
200 enrolled
Hepatitis B InfectionChronic InfectionViremia
NCT01252940Phase 3Completed

Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF

Started Nov 2010
482 enrolled
HIV-1 Infection

Loss of Exclusivity

LOE Date
Feb 15, 2033
84 months away
Patent Expiry
Feb 15, 2033

Patent Records (4)

Patent #ExpiryTypeUse Code
8754065
Aug 15, 2032
SubstanceProduct
U-257
9296769
Aug 15, 2032
SubstanceProduct
U-257
8754065*PED
Feb 15, 2033
9296769*PED
Feb 15, 2033