FdaApplication
BLA 125261
Identifiers
- fda_app_no: BLA125261
Properties
| Property | Value |
|---|---|
| applicant_name | Janssen Biotech, Inc. |
| application_type | BLA |
| approval_date | 2009-09-25 |
Revenue by product
STELARA
| Period | Revenue |
|---|---|
| Q2 2026 | $740.0M |
| Q1 2026 | $656.0M |
| Q4 2025 | $1.2B |
| Q3 2025 | $1.6B |
| Q2 2025 | $1.7B |
| Q1 2025 | $1.6B |
| Q4 2024 | $2.3B |
| Q3 2024 | $2.7B |
| Q2 2024 | $2.9B |
| Q1 2024 | $2.5B |
| Q4 2023 | $2.8B |
| Q3 2023 | $2.9B |
| Q2 2023 | $2.8B |
| Q1 2023 | $2.4B |
| Q4 2022 | $2.4B |
| Q3 2022 | $2.4B |
| Q2 2022 | $2.6B |
| Q1 2022 | $2.3B |
| Q4 2021 | $2.3B |
| Q3 2021 | $2.4B |
| Q2 2021 | $2.3B |
| Q1 2021 | $2.1B |
| Q4 2020 | $2.2B |
| Q3 2020 | $1.9B |
| Q2 2020 | $1.7B |
| Q1 2020 | $1.8B |
| Q4 2019 | $1.7B |
| Q3 2019 | $1.7B |
| Q2 2019 | $1.6B |
| Q1 2019 | $1.4B |
| Q4 2018 | $1.4B |
| Q3 2018 | $1.3B |
| Q2 2018 | $1.3B |
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.
STELARA
| Period | Revenue |
|---|---|
| Q2 2026 | $740.0M |
| Q1 2026 | $656.0M |
| Q4 2025 | $1.2B |
| Q3 2025 | $1.6B |
| Q2 2025 | $1.7B |
| Q1 2025 | $1.6B |
| Q4 2024 | $2.3B |
| Q3 2024 | $2.7B |
| Q2 2024 | $2.9B |
| Q1 2024 | $2.5B |
| Q4 2023 | $2.8B |
| Q3 2023 | $2.9B |
| Q2 2023 | $2.8B |
| Q1 2023 | $2.4B |
| Q4 2022 | $2.4B |
| Q3 2022 | $2.4B |
| Q2 2022 | $2.6B |
| Q1 2022 | $2.3B |
| Q4 2021 | $2.3B |
| Q3 2021 | $2.4B |
| Q2 2021 | $2.3B |
| Q1 2021 | $2.1B |
| Q4 2020 | $2.2B |
| Q3 2020 | $1.9B |
| Q2 2020 | $1.7B |
| Q1 2020 | $1.8B |
| Q4 2019 | $1.7B |
| Q3 2019 | $1.7B |
| Q2 2019 | $1.6B |
| Q1 2019 | $1.4B |
| Q4 2018 | $1.4B |
| Q3 2018 | $1.3B |
| Q2 2018 | $1.3B |
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 (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| STELARA | USTEKINUMAB | 45MG/0.5ML | INJECTABLE;INJECTION |
| STELARA | USTEKINUMAB | 90MG/ML | INJECTABLE;INJECTION |
| STELARA | — | 90MG/ML | Injection |
| STELARA | — | 45MG/0.5ML | Injection |
4 products