FDA Orange Book
Generic for Wakix
Wakix contains pitolisant. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Wakix is pitolisant. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Wakix products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 17.8MG BASE | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | EQ 4.45MG BASE | Marketed (Rx) | AB | 3 | AB |
NDA 211150, held by HARMONY BIOSCIENCES MANAGEMENT INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pitolisant
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVITIUM PHARMA LLC | 218495 | AB (A-rated, therapeutically equivalent) | July 21, 2026 | EQ 17.8MG BASE, EQ 4.45MG BASE |
| LUPIN LTD | 218846 | AB (A-rated, therapeutically equivalent) | August 14, 2026 | EQ 17.8MG BASE, EQ 4.45MG BASE |
| MSN LABORATORIES PRIVATE LTD | 218873 | AB (A-rated, therapeutically equivalent) | August 14, 2026 | EQ 17.8MG BASE, EQ 4.45MG BASE |
Wakix patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8354430 | February 6, 2026 | Method of use | U-1101 | 211150 |
| 8354430 | February 6, 2026 | Method of use | U-1102 | 211150 |
| 8486947 | September 26, 2029 | Method of use | U-1101 | 211150 |
| 8486947 | September 26, 2029 | Method of use | U-1102 | 211150 |
| 8207197 | March 7, 2030 | Drug substance, Drug product | None | 211150 |
Wakix exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-255 | Orphan drug exclusivity | August 14, 2026 | 211150 |
| NPP | New patient population | June 21, 2027 | 211150 |
| ODE-331 | Orphan drug exclusivity | October 13, 2027 | 211150 |
| ODE-489 | Orphan drug exclusivity | June 21, 2031 | 211150 |
| ODE-519 | Orphan drug exclusivity | February 13, 2033 | 211150 |
Wakix NDC codes
Questions
Is there a generic for Wakix?
Yes. The generic name for Wakix is pitolisant. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Wakix?
The active ingredient in Wakix is pitolisant, per the FDA Orange Book.
When does the Wakix patent expire?
The last patent listed for Wakix in the Orange Book expires March 7, 2030. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.