WAKIX

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Aug 14, 2019

   6 yr 11 mo ago

2. Patent 8354430 expires

   Listed method-of-use patent (U-1101) expiration.

   Feb 06, 2026

   4 mo ago

3. Patent 8354430 expires

   Listed method-of-use patent (U-1102) expiration.

   Feb 06, 2026

   4 mo ago

4. Today

5. Exclusivity ends · ODE-255

   Orphan-drug exclusivity (7 years)

   Aug 14, 2026

   in 2 mo

6. Exclusivity ends · NPP

   New patient population exclusivity (3 years)

   Jun 21, 2027

   in 1 yr

7. Exclusivity ends · ODE-331

   Orphan-drug exclusivity (7 years)

   Oct 13, 2027

   in 1 yr 4 mo

8. Patent 8486947 expires

   Listed method-of-use patent (U-1101) expiration.

   Sep 26, 2029

   in 3 yr 4 mo

9. Patent 8486947 expires

   Listed method-of-use patent (U-1102) expiration.

   Sep 26, 2029

   in 3 yr 4 mo

10. Patent 8207197 expires

    Listed drug substance patent expiration.

    Mar 07, 2030

    in 3 yr 9 mo

11. Exclusivity ends · ODE-489

    Orphan-drug exclusivity (7 years)

    Jun 21, 2031

    in 5 yr 1 mo

12. Exclusivity ends · ODE-519

    Orphan-drug exclusivity (7 years)

    Feb 13, 2033

    in 6 yr 9 mo

Pharmaceutical detail

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (5)

• ODE-255Orphan-drug exclusivity (7 years)

  Aug 14, 2026

  in 2 mo

• NPPNew patient population exclusivity (3 years)

  Jun 21, 2027

  in 1 yr

• ODE-331Orphan-drug exclusivity (7 years)

  Oct 13, 2027

  in 1 yr 4 mo

• ODE-489Orphan-drug exclusivity (7 years)

  Jun 21, 2031

  in 5 yr 1 mo

• ODE-519Orphan-drug exclusivity (7 years)

  Feb 13, 2033

  in 6 yr 9 mo

Listed patents (5)