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ATAZANAVIR SULFATE
Atazanavir sulfate is a marketed antiretroviral drug primarily indicated for the treatment of HIV-1 infection. Its key strength lies in its established market presence and the protection afforded by a key composition patent expiring in 2028. The primary risk is the eventual loss of patent protection, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | ATAZANAVIR SULFATE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2003 |
Approved indications
- HIV-1 Infection Treatment
Common side effects
- Nausea
- Jaundice/scleral icterus
- Rash
- Headache
- Abdominal pain
- Vomiting
- Insomnia
- Peripheral neurologic symptoms
- Dizziness
- Myalgia
- Diarrhea
- Depression
Key clinical trials
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults (PHASE3)
- Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2, PHASE3)
- Population Pharmacokinetics of Antiretroviral in Children
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ATAZANAVIR SULFATE CI brief — competitive landscape report
- ATAZANAVIR SULFATE updates RSS · CI watch RSS