COMPLERA
Peakemtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate
NDAORALTABLETPriority Review
Approved
Aug 2011
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
7/8 — Comprehensive
Priority Review
COMPLERA (emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate) by Gilead Sciences is nucleoside reverse transcriptase inhibitors [moa]. Approved for human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]. First approved in 2011.
Drug data last refreshed 12h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COMPLERA is a fixed-dose combination tablet containing emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate for the treatment of human immunodeficiency virus (HIV) infection. It works by inhibiting reverse transcriptase, a key enzyme in HIV replication. The product combines three nucleoside/nucleotide reverse transcriptase inhibitors into a single daily oral formulation.
$26MPart D
PeakStable
6.2 years to LOECOMPLERA is in mature peak lifecycle with modest Part D spending ($26M) and low claim volume (6,649), indicating a stable but non-growth commercial footprint relative to newer alternatives within the Gilead HIV portfolio.
Mechanism of Action
Nucleoside Reverse Transcriptase Inhibitors
Pharmacologic Class:
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Assessing Short and Long Term Compliance With Caloric Intake in HIV Positive Women Taking Complera
Started Oct 2012
33 enrolled
HIV-1 Infection
Career Relevance
COMPLERA roles are primarily in commercial defense and managed markets, focusing on retaining patients and maintaining reimbursement against superior alternatives like ODEFSEY. Career opportunities emphasize market access, payer engagement, and strategic patient retention rather than growth or launch-phase activities.
Brand Manager
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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.