pitolisant hydrochloride · Harmony · NDA 211150
Wakix
Blocked by exclusivity: ODE-519.
FDA has approved 4 generic applications (ANDAs) for Wakix, though its earliest generic-entry date is 13 Feb 2033 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 2 unexpired
3 Orange Book listing rows for 2 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8207197 | drug substance, drug product | 7 Mar 2030 |
| US 8486947 | use U-1101, U-1102 | 26 Sep 2029 |
| US 8486947 listing row | use U-1101 | 26 Sep 2029 |
| US 8486947 listing row | 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
- First generic approved · ANDA 218495, Novitium Pharma · 211150-001Approved 21 Jul 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218495, Novitium Pharma · 211150-001Approved 21 Jul 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218873, Msn · 211150-001Approved 14 Aug 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218846, Lupin · 211150-001Approved 14 Aug 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218832, Annora Pharma · 211150-001Approved 8 Oct 2026Detected 25 Oct 2026Historical import
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