FdaApplication
NDA 208351
Identifiers
- fda_app_no: NDA208351
Properties
| Property | Value |
|---|---|
| applicant_name | GILEAD SCIENCES INC |
| application_type | NDA |
| approval_date | 2016-03-01 |
Revenue by product
ODEFSEY
| Period | Revenue |
|---|---|
| Q2 2026 | $239.0M* |
| Q1 2026 | $221.0M* |
| Q4 2025 | $310.0M* |
| Q3 2025 | $277.0M* |
| Q2 2025 | $298.0M* |
| Q1 2025 | $281.0M* |
| Q4 2024 | $336.0M* |
| Q3 2024 | $326.0M* |
| Q2 2024 | $315.0M* |
| Q1 2024 | $310.0M* |
| Q4 2023 | $339.0M* |
| Q3 2023 | $343.0M* |
| Q2 2023 | $351.0M* |
| Q1 2023 | $317.0M* |
| Q4 2022 | $392.0M* |
| Q3 2022 | $374.0M* |
Revenue as this company reported it for this product. A combination product's amount is stated once, for the product, and never divided across its ingredients. A fourth quarter is the reported full year less nine months, since no filing states one.
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ODEFSEY | EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE | 200MG;EQ 25MG BASE;EQ 25MG BASE | TABLET;ORAL |
1 product