NDAORALTABLETPriority Review
Approved
Jul 2006
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
15
Data completeness
5/8 — Partial
Priority Review
ATRIPLA (efavirenz; emtricitabine; tenofovir disoproxil fumarate) by Gilead Sciences is fixed-dose combination of antiviral drugs efavirenz, emtricitabine and tenofovir disoproxil fumarate. First approved in 2006.
Drug data last refreshed 14h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ATRIPLA is a fixed-dose combination tablet containing three antiretroviral agents: efavirenz, emtricitabine, and tenofovir disoproxil fumarate. It is indicated for treatment of HIV-1 infection in treatment-naïve and treatment-experienced adult patients. The combination works by inhibiting reverse transcriptase and nucleotide reverse transcriptase to suppress viral replication.
$0.085BPart D
LOE ApproachingDeclining
2.5 years to LOEProduct is in advanced stages of patent erosion with limited remaining market exclusivity; commercial teams are likely focused on defense and transition planning rather than growth initiatives.
Mechanism of Action
fixed-dose combination of antiviral drugs efavirenz, emtricitabine and tenofovir disoproxil fumarate. [See ].
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (15)
B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults
Started Oct 2018
28 enrolled
HIV-1-infection
Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028)
Started Mar 2016
86 enrolled
HIV-1Central Nervous System
SSAT058: Atripla to Eviplera Switch in Patients Without Central Nervous System Symptoms
Started Nov 2015
40 enrolled
HIV
Evolution of Plasma Lipid Profile in Patients With HIV1 Who Change Atripla to Eviplera Compared to Continue With Atripla
Started Sep 2015
30 enrolled
HIV-1
Switching From Efavirenz/Atripla to Rilpivirine Among Patients With Neurocognitive or Neuropsychological Side Effects
Started Jul 2015
74 enrolled
Impaired CognitionDepression/AnxietyPoor Quality Sleep+2 more
Worked on ATRIPLA at Gilead Sciences? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.