FdaApplication
NDA 217003
Identifiers
- fda_app_no: NDA217003
Properties
| Property | Value |
|---|---|
| applicant_name | PHARMACYCLICS LLC |
| application_type | NDA |
| approval_date | 2022-08-24 |
Revenue by product
IMBRUVICA
| Period | Revenue |
|---|---|
| Q2 2026 | $532.0M |
| Q1 2026 | $556.0M |
| Q4 2025 | $671.0M |
| Q3 2025 | $706.0M |
| Q2 2025 | $754.0M |
| Q1 2025 | $738.0M |
| Q4 2024 | $848.0M |
| Q3 2024 | $828.0M |
| Q2 2024 | $833.0M |
| Q1 2024 | $838.0M |
| Q4 2023 | $903.0M |
| Q3 2023 | $908.0M |
| Q2 2023 | $907.0M |
| Q1 2023 | $878.0M |
| Q4 2022 | $1.1B |
| Q3 2022 | $1.1B |
| Q2 2022 | $1.1B |
| Q1 2022 | $1.2B |
| Q4 2021 | $1.4B |
| Q3 2021 | $1.4B |
| Q2 2021 | $1.4B |
| Q1 2021 | $1.3B |
| Q4 2020 | $1.4B |
| Q3 2020 | $1.4B |
| Q2 2020 | $1.3B |
| Q1 2020 | $1.2B |
| Q4 2019 | $1.3B |
| Q3 2019 | $1.3B |
| Q2 2019 | $1.1B |
| Q1 2019 | $1.0B |
| Q4 2018 | $1.0B |
| Q3 2018 | $972.0M |
| Q2 2018 | $850.0M |
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 (7)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| IMBRUVICA | IBRUTINIB | 70MG | CAPSULE;ORAL |
| IMBRUVICA | IBRUTINIB | 230MG | TABLET;ORAL |
| IMBRUVICA | IBRUTINIB | 140MG | CAPSULE;ORAL |
| IMBRUVICA | IBRUTINIB | 70MG/ML | SUSPENSION;ORAL |
| IMBRUVICA | IBRUTINIB | 140MG | TABLET;ORAL |
| IMBRUVICA | IBRUTINIB | 560MG | TABLET;ORAL |
| IMBRUVICA | IBRUTINIB | 420MG | TABLET;ORAL |
7 products