Quick answers
- What is Cobicistat used for?
- The FDA-approved label (Tybost, Gilead Sciences, Inc., February 10, 2026) says: “TYBOST is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection in adults and in pediatric patients weighing at least 14 kg. Limitations of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cobicistat have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cobicistat?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cobicistat been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Cobicistat?
- 1 company lists prescription products of Cobicistat in the FDA NDC Directory, including Gilead Sciences, Inc..
What Cobicistat is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TYBOST is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection in adults and in pediatric patients weighing at least 14 kg. Limitations of Use …
— FDA label: Tybost, Gilead Sciences, Inc., effective February 10, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Tybost |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Gilead Sciences, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA203094 TYBOST | Gilead Sciences Inc | September 24, 2014 | 15, latest June 20, 2025 2025: Efficacy · 2025: Efficacy · 2021: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1551993, 1551999, 2719618, 2719620 |
|---|---|
| SPL set ID of the quoted label | 3784c35c-e87f-410c-900b-8fd6313c6010 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA203094 |
| Active ingredients (FDA) | COBICISTAT |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tybost, Gilead Sciences, Inc., effective February 10, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →