NDAORALTABLETPriority Review
Approved
Aug 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
TRUVADA (emtricitabine and tenofovir disoproxil fumarate) by Gilead Sciences is nucleoside reverse transcriptase inhibitors [moa]. First approved in 2004.
Drug data last refreshed 19m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRUVADA is a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors (NRTIs) that work by blocking HIV reverse transcriptase. It is indicated for HIV-1 treatment in combination with other antiretrovirals and for pre-exposure prophylaxis (PrEP) in at-risk populations. The drug has been a cornerstone of HIV management since its 2004 approval.
$6MPart D
LOE ApproachingProduct is approaching loss of exclusivity with moderate commercial pressure (30%), signaling transition from growth to defense and potential team restructuring.
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 (20)
Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs
Started Sep 2020
394 enrolled
HIV Infections
Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy
Started Jan 2020
1,104 enrolled
HIV Infections
Comparative Study of PK and BE of VM-1500FDC (Fixed-dose Combination) and Elpida® With Truvada® сo-administrated 1 Daily Fasting in Healthy Subjects
Started Jun 2018
140 enrolled
HIV-1-infection
Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in Adolescents
Started Apr 2015
148 enrolled
HIV Infections
Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292)
Started May 2014
802 enrolled
HIV Infection
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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.