Applicant, as named in the Orange Book
Harmony
Next listed expiry: Wakix on 13 Feb 2033. 1 products with live protection, 0 without.
Products with listed protection
| Drug | Ingredient | NDA | Earliest generic entry | Basis |
|---|
| Wakix · 2 strengths pitolisant hydrochloride | pitolisant hydrochloride | 211150 | 13 Feb 2033 | exclusivity |
Recent events
- 25 Oct 2026Wakix · First generic approved 21 Jul 2026
- 25 Oct 2026Wakix · Generic approved 21 Jul 2026
- 25 Oct 2026Wakix · Generic approved 14 Aug 2026
- 25 Oct 2026Wakix · Generic approved 14 Aug 2026
- 25 Oct 2026Wakix · Generic approved 8 Oct 2026