NDAORALTABLETPriority Review
Approved
Aug 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
TRUVADA (emtricitabine and tenofovir disoproxil fumarate) by Gilead Sciences is nucleoside reverse transcriptase inhibitors [moa]. Approved for hiv infection. First approved in 2004.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRUVADA is a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, nucleoside reverse transcriptase inhibitors (NRTIs) used to treat human immunodeficiency virus (HIV) infection. It works by inhibiting the reverse transcriptase enzyme, preventing viral replication in infected cells. TRUVADA is also used for pre-exposure prophylaxis (PrEP) in high-risk, HIV-negative individuals.
$0.006BPart D
LOE ApproachingDeclining
Approaching loss of exclusivity with minimal Part D spending signals a declining brand team and focus shift toward transition planning and generic support.
Mechanism of Action
Nucleoside Reverse Transcriptase Inhibitors
Pharmacologic Class:
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Indications (1)
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
Worked on TRUVADA 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.