ZILBRYSQ

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Oct 17, 2023

   2 yr 9 mo ago

2. Today

3. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Oct 17, 2028

   in 2 yr 4 mo

4. Exclusivity ends · ODE-446

   Orphan-drug exclusivity (7 years)

   Oct 17, 2030

   in 4 yr 5 mo

5. Patent 10106579 expires

   Listed drug substance patent expiration.

   Jun 12, 2035

   in 9 yr 1 mo

6. Patent 10208089 expires

   Listed drug substance patent expiration.

   Jun 12, 2035

   in 9 yr 1 mo

7. Patent 10435438 expires

   Listed drug substance patent expiration.

   Jun 12, 2035

   in 9 yr 1 mo

8. Patent 10562934 expires

   Listed drug substance patent expiration.

   Jun 12, 2035

   in 9 yr 1 mo

9. Patent 10835574 expires

   Listed drug product patent expiration.

   Jun 12, 2035

   in 9 yr 1 mo

10. Patent 11014965 expires

    Listed drug substance patent expiration.

    Jun 12, 2035

    in 9 yr 1 mo

11. Patent 11535650 expires

    Listed drug product patent expiration.

    Jun 12, 2035

    in 9 yr 1 mo

12. Patent 11752190 expires

    Listed drug product patent expiration.

    Jun 12, 2035

    in 9 yr 1 mo

13. Patent 11965040 expires

    Listed drug product patent expiration.

    Jun 12, 2035

    in 9 yr 1 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)

  Oct 17, 2028

  in 2 yr 4 mo

• ODE-446Orphan-drug exclusivity (7 years)

  Oct 17, 2030

  in 4 yr 5 mo

Listed patents (9)