Two medicines, side by side
Darunavir vs atazanavir
Darunavir and atazanavir are both labeled for HIV. Drugs@FDA records approvals of darunavir since 2006 and of atazanavir since 2003. Pharmacies paid $1.16 per darunavir 600 mg tablet and $2.23 per atazanavir sulfate 300 mg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. How each works, in its label's words: Darunavir, “Mechanism of Action Darunavir is an inhibitor of the HIV-1 protease.”; Atazanavir, “Atazanavir is an HIV-1 antiretroviral drug [see Microbiology (12.4) ].”
Check it at the source: the darunavir FDA label on DailyMed (effective August 29, 2025); the atazanavir FDA label on DailyMed (effective August 6, 2025).
Highlights of the darunavir record
Darunavir (Prezista) · label of August 29, 2025
Used for
From the label: indicationsPREZISTA, co-administered with ritonavir (PREZISTA/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14) ]. […]
On the market
- Earliest approval on file
- June 23, 2006
- Generic labelers
- 13 labelers
- Pharmacy cost
- $1.16 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Highlights of the atazanavir record
Atazanavir (Reyataz) · label of August 6, 2025
Used for
From the label: indicationsAtazanavir capsule is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4) ]. […]
On the market
- Earliest approval on file
- June 20, 2003
- Generic labelers
- 4 labelers
- Pharmacy cost
- $2.23 per capsule
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Source: FDA drug labels via openFDA (Darunavir label of August 29, 2025, Atazanavir label of August 6, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do darunavir and atazanavir differ on the record?
How each works, in its label's words: Darunavir, “Mechanism of Action Darunavir is an inhibitor of the HIV-1 protease.”; Atazanavir, “Atazanavir is an HIV-1 antiretroviral drug [see Microbiology (12.4) ].”
Both are in FDA's class protease inhibitors.
Half-life, in each label's words: Darunavir, “The terminal elimination half-life of darunavir was approximately 15 hours when co-administered with ritonavir.”; Atazanavir, “The mean elimination half-life of atazanavir in healthy participants (n=214) and adult participants with HIV-1 (n=13) …”
Generics: darunavir since 2017; atazanavir since 2014 (Drugs@FDA).
| Darunavir | Atazanavir | |
|---|---|---|
| Labeled for | HIV | HIV |
| Pharmacologic class | Protease Inhibitor | Protease Inhibitor |
| How it works (label) | Darunavir is an HIV-1 antiviral drug [see Microbiology (12.4) ]. Mechanism of Action Darunavir is an inhibitor of the HIV-1 protease. | Atazanavir is an HIV-1 antiretroviral drug [see Microbiology (12.4) ]. |
| Half-life (label) | The terminal elimination half-life of darunavir was approximately 15 hours when co-administered with ritonavir. | The mean elimination half-life of atazanavir in healthy participants (n=214) and adult participants with HIV-1 (n=13) was approximately 7 hours at steady state following a dose of 400 mg daily with a light meal. |
| Earliest approval on file (Drugs@FDA) | June 23, 2006 | June 20, 2003 |
| First generic approved | November 21, 2017 | April 22, 2014 |
| Generic labelers (NDC) | 13 labelers | 4 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $1.16 per tablet (Darunavir 600 mg tablet) | $2.23 per capsule (Atazanavir sulfate 300 mg capsule) |
| 12-month price change | -4% | -28% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 0 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 15,039 | 14,285 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Darunavir label, drug interactionsConcomitant Drug Class Drug Name Examples: Other HIV protease inhibitors, except atazanavir [see ]; Effect on Concentration of Darunavir Or Concomitant Drug: As co-administration with PREZISTA/ritonavir has not been studied, co-administration is not recommended.
Source: FDA drug labels via openFDA
What next?
- Alternatives to darunavir
- every medicine labeled for the same conditions