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Atazanavir/Ritonavir

Phase 3
BRISTOL MYERS SQUIBB CO (CELG-RI)

Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

4

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape
Drug Information

Target Indication

HIV

Clinical Trial

NCT01003990

Last updated: 2/26/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA3/25/2019

Atazanavir Krka

Atazanavir Krka capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products. Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (? 4 PI mutations). The choice of Atazanavir Krka in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.

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EMA11/9/2017

Ritonavir Viatris (previously Ritonavir Mylan)

Ritonavir is indicated as a pharmacokinetic enhancer of co-administered protease inhibitors as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected patients (adults and children of 2 years of age and older).

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EMA8/22/2016

Atazanavir Viatris (previously Atazanavir Mylan)

Atazanavir Viatris, co-administered with low dose ritonavir, is indicated for the treatment of HIV 1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products.Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations). There are very limited data available from children aged 6 to less than 18 years. The choice of Atazanavir Viatrisin treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.

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EMA8/25/1996

Norvir

Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1-infected patients (adults and children of two years of age and older).

View on EMA
Drug Science
Mechanism of action & safety profile
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