DAYBUE STIX

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Dec 11, 2025

   6 mo ago

2. Today

3. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Mar 10, 2028

   in 1 yr 9 mo

4. Exclusivity ends · PED

   Pediatric exclusivity (adds 6 months)

   Sep 10, 2028

   in 2 yr 3 mo

5. Exclusivity ends · ODE*

   FDA marketing exclusivity

   Mar 10, 2030

   in 3 yr 9 mo

6. Exclusivity ends · PED

   Pediatric exclusivity (adds 6 months)

   Sep 10, 2030

   in 4 yr 3 mo

7. Patent 9212204 expires

   Listed method-of-use patent (U-3556) expiration.

   Jan 27, 2032

   in 5 yr 8 mo

8. Patent 9212204*PED expires

   Listed listed patent expiration.

   Jul 27, 2032

   in 6 yr 2 mo

9. Patent 11370755 expires

   Listed drug substance patent expiration.

   Aug 03, 2040

   in 14 yr 4 mo

10. Patent 11370755*PED expires

    Listed listed patent expiration.

    Feb 03, 2041

    in 14 yr 10 mo

11. Patent 11827600 expires

    Listed drug substance patent expiration.

    Jul 12, 2042

    in 16 yr 4 mo

12. Patent 12492167 expires

    Listed drug substance patent expiration.

    Jul 12, 2042

    in 16 yr 4 mo

13. Patent 11827600*PED expires

    Listed listed patent expiration.

    Jan 12, 2043

    in 16 yr 10 mo

14. Patent 12492167*PED expires

    Listed listed patent expiration.

    Jan 12, 2043

    in 16 yr 10 mo

Pharmaceutical detail

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

• DAYBUEBrand (NDA)

  NDA 217026 · ACADIA PHARMS INC

  2023

Marketing exclusivity (4)

• NCENew chemical entity exclusivity (5 years)

  Mar 10, 2028

  in 1 yr 9 mo

• PEDPediatric exclusivity (adds 6 months)

  Sep 10, 2028

  in 2 yr 3 mo

• ODE*FDA marketing exclusivity

  Mar 10, 2030

  in 3 yr 9 mo

• PEDPediatric exclusivity (adds 6 months)

  Sep 10, 2030

  in 4 yr 3 mo

Listed patents (8)