WAYRILZ

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Aug 29, 2025

   10 mo ago

2. Today

3. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Aug 29, 2030

   in 4 yr 3 mo

4. Exclusivity ends · ODE-552

   Orphan-drug exclusivity (7 years)

   Aug 29, 2032

   in 6 yr 3 mo

5. Patent 9580427 expires

   Listed drug substance patent expiration.

   Mar 01, 2033

   in 6 yr 10 mo

6. Patent 8940744 expires

   Listed drug substance patent expiration.

   Sep 06, 2033

   in 7 yr 4 mo

7. Patent 9266895 expires

   Listed drug substance patent expiration.

   Sep 06, 2033

   in 7 yr 4 mo

8. Patent 9994576 expires

   Listed drug substance patent expiration.

   Sep 06, 2033

   in 7 yr 4 mo

9. Patent 9994576 expires

   Listed drug substance patent expiration.

   Sep 06, 2033

   in 7 yr 4 mo

10. Patent 12178818 expires

    Listed method-of-use patent (U-4267) expiration.

    Oct 13, 2040

    in 14 yr 6 mo

11. Patent 11708370 expires

    Listed drug substance patent expiration.

    Feb 20, 2041

    in 14 yr 11 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 (2)

• NCENew chemical entity exclusivity (5 years)

  Aug 29, 2030

  in 4 yr 3 mo

• ODE-552Orphan-drug exclusivity (7 years)

  Aug 29, 2032

  in 6 yr 3 mo

Listed patents (7)