pitolisant hydrochloride · Harmony · NDA 211150
Wakix
Earliest generic entry, as listed · earliest of 2 marketed strengths
13 Feb 2033
Blocked by exclusivity: ODE-519.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8207197 | substance, product | 7 Mar 2030 |
| US 8486947 | use U-1101 | 26 Sep 2029 |
| US 8486947 | use U-1102 | 26 Sep 2029 |
Exclusivities · 4 unexpired
| ODE-519 | orphan drug (7 years) | 13 Feb 2033 |
| ODE-489 | orphan drug (7 years) | 21 Jun 2031 |
| ODE-331 | orphan drug (7 years) | 13 Oct 2027 |
| NPP | new patient population | 21 Jun 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 25 Oct 2026First generic approved · 211150-00121 Jul 2026
- 25 Oct 2026Generic approved · 211150-00121 Jul 2026
- 25 Oct 2026Generic approved · 211150-00114 Aug 2026
- 25 Oct 2026Generic approved · 211150-00114 Aug 2026
- 25 Oct 2026Generic approved · 211150-0018 Oct 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211150 · 001 · RLD | tablet, oral | EQ 4.45MG BASE | 13 Feb 2033 |
| 211150 · 002 · RLD | tablet, oral | EQ 17.8MG BASE | 13 Feb 2033 |
Expired or delisted (3)
- US 8354430 · use U-1102 · 6 Feb 2026
- US 8354430 · use U-1101 · 6 Feb 2026
- ODE-255 · 14 Aug 2026