VOXZOGO

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Nov 19, 2021

   4 yr 8 mo ago

2. Today

3. Exclusivity ends · NPP

   New patient population exclusivity (3 years)

   Oct 20, 2026

   in 4 mo

4. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Nov 19, 2026

   in 5 mo

5. Exclusivity ends · ODE-387

   Orphan-drug exclusivity (7 years)

   Nov 19, 2028

   in 2 yr 5 mo

6. Patent RE48267 expires

   Listed method-of-use patent (U-3927) expiration.

   May 20, 2030

   in 4 yr

7. Exclusivity ends · ODE-449

   Orphan-drug exclusivity (7 years)

   Oct 20, 2030

   in 4 yr 5 mo

8. Patent 8198242 expires

   Listed drug substance patent expiration.

   Jun 11, 2035

   in 9 yr 1 mo

9. Patent 10646550 expires

   Listed drug product patent expiration.

   Aug 01, 2036

   in 10 yr 3 mo

10. Patent 11590204 expires

    Listed drug product patent expiration.

    Aug 01, 2036

    in 10 yr 3 mo

11. Patent 11911446 expires

    Listed method-of-use patent (U-3927) expiration.

    Aug 01, 2036

    in 10 yr 3 mo

12. Patent 12514906 expires

    Listed drug product patent expiration.

    Aug 01, 2036

    in 10 yr 3 mo

13. Patent 9907834 expires

    Listed drug product patent expiration.

    Aug 01, 2036

    in 10 yr 3 mo

14. Patent 12233106 expires

    Listed method-of-use patent (U-3927) expiration.

    Jul 11, 2042

    in 16 yr 4 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 (4)

• NPPNew patient population exclusivity (3 years)

  Oct 20, 2026

  in 4 mo

• NCENew chemical entity exclusivity (5 years)

  Nov 19, 2026

  in 5 mo

• ODE-387Orphan-drug exclusivity (7 years)

  Nov 19, 2028

  in 2 yr 5 mo

• ODE-449Orphan-drug exclusivity (7 years)

  Oct 20, 2030

  in 4 yr 5 mo

Listed patents (8)