FdaApplication
NDA 211150
Identifiers
- fda_app_no: NDA211150
Properties
| Property | Value |
|---|---|
| applicant_name | HARMONY BIOSCIENCES MANAGEMENT INC |
| application_type | NDA |
| approval_date | 2019-08-14 |
Revenue by product
WAKIX
| Period | Revenue |
|---|---|
| Q2 2026 | $261.3M† |
| Q1 2026 | $215.4M† |
| Q4 2025 | $243.8M† |
| Q3 2025 | $239.5M† |
| Q2 2025 | $200.5M† |
| Q1 2025 | $184.7M† |
| Q4 2024 | $201.3M† |
| Q3 2024 | $186.0M† |
| Q2 2024 | $172.8M† |
| Q1 2024 | $154.6M† |
| Q4 2023 | $168.4M† |
| Q3 2023 | $160.3M† |
| Q2 2023 | $134.2M† |
| Q1 2023 | $119.1M† |
| Q4 2022 | $128.3M† |
| Q3 2022 | $117.2M† |
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. A figure marked † is the company's one reported revenue line rather than a product breakdown.
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| WAKIX | PITOLISANT HYDROCHLORIDE | EQ 4.45MG BASE | TABLET;ORAL |
| WAKIX | PITOLISANT HYDROCHLORIDE | EQ 17.8MG BASE | TABLET;ORAL |
2 products