FdaApplication
BLA 761036
Identifiers
- fda_app_no: BLA761036
Properties
| Property | Value |
|---|---|
| applicant_name | Janssen Biotech, Inc. |
| application_type | BLA |
| approval_date | 2015-11-16 |
Revenue by product
DARZALEX
| Period | Revenue |
|---|---|
| Q2 2026 | $4.2B |
| Q1 2026 | $4.0B |
| Q4 2025 | $3.9B |
| Q3 2025 | $3.7B |
| Q2 2025 | $3.5B |
| Q1 2025 | $3.2B |
| Q4 2024 | $3.1B |
| Q3 2024 | $3.0B |
| Q2 2024 | $2.9B |
| Q1 2024 | $2.7B |
| Q4 2023 | $2.5B |
| Q3 2023 | $2.5B |
| Q2 2023 | $2.4B |
| Q1 2023 | $2.3B |
| Q4 2022 | $2.1B |
| Q3 2022 | $2.1B |
| Q2 2022 | $2.0B |
| Q1 2022 | $1.9B |
| Q4 2021 | $1.6B |
| Q3 2021 | $1.6B |
| Q2 2021 | $1.4B |
| Q1 2021 | $1.4B |
| Q4 2020 | $1.3B |
| Q3 2020 | $1.1B |
| Q2 2020 | $901.0M |
| Q1 2020 | $937.0M |
| Q4 2019 | $830.0M |
| Q3 2019 | $765.0M |
| Q2 2019 | $774.0M |
| Q1 2019 | $629.0M |
| Q4 2018 | $584.0M |
| Q3 2018 | $498.0M |
| Q2 2018 | $511.0M |
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 (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DARZALEX | DARATUMUMAB | 100MG/5ML | Injection |
| DARZALEX | DARATUMUMAB | 400MG/20ML | Injection |
2 products