NDAORALCAPSULEPriority Review
Approved
Jun 2003
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
21
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REYATAZ (atazanavir) is an oral HIV-1 protease inhibitor approved in 2003 for treatment of HIV infection and AIDS. It works by inhibiting HIV protease, preventing viral replication and reducing viral load in infected patients. The drug is also indicated for management of associated metabolic complications including hyperlipidemia and lipodystrophy.
$0.959MPart D
LOE ApproachingDeclining
As LOE approaches, the brand team is likely contracting with focus shifting to managed care, generics support, and downstream patient assistance programs rather than new market expansion.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (21)
NA-831, Atazanavir and Dexamethasone Combination Therapy for the Treatment of COVID-19 Infection
Started Jun 2022
525 enrolled
Coronavirus InfectionSevere Acute Respiratory InfectionSevere Acute Respiratory Syndrome Coronavirus 2
A Study to Compare the Drug Levels of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations and the Coadministration of the Individual Reference Products in Healthy Adults Under Fed Conditions
Started May 2022
42 enrolled
Healthy Participants
The Nitazoxanide Plus Atazanavir for COVID-19 Study
Started Oct 2020
57 enrolled
Covid-19
A Study to Examine the Acceptable Taste and to Estimate the Amount of Atazanavir and Cobicistat in the Body When Taken as a Combination Product Versus When Taken as Separate Products at the Same Time
Started Feb 2020
34 enrolled
Healthy Participants
Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults
Started Nov 2015
578 enrolled
HIV-1 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.