RIVFLOZA

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Sep 29, 2023

   2 yr 9 mo ago

2. Today

3. Exclusivity ends · NPP

   New patient population exclusivity (3 years)

   Mar 27, 2028

   in 1 yr 10 mo

4. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Sep 29, 2028

   in 2 yr 4 mo

5. Exclusivity ends · ODE-443

   Orphan-drug exclusivity (7 years)

   Sep 29, 2030

   in 4 yr 4 mo

6. Exclusivity ends · ODE-531

   Orphan-drug exclusivity (7 years)

   Mar 27, 2032

   in 5 yr 10 mo

7. Patent 10351854 expires

   Listed drug substance patent expiration.

   Oct 09, 2035

   in 9 yr 5 mo

8. Patent 10738311 expires

   Listed drug substance patent expiration.

   Oct 09, 2035

   in 9 yr 5 mo

9. Patent 11359203 expires

   Listed drug substance patent expiration.

   Oct 09, 2035

   in 9 yr 5 mo

10. Patent 11053502 expires

    Listed drug substance patent expiration.

    Oct 29, 2035

    in 9 yr 6 mo

11. Patent 11286488 expires

    Listed drug substance patent expiration.

    Oct 12, 2038

    in 12 yr 6 mo

12. Patent 11661604 expires

    Listed drug substance patent expiration.

    Oct 12, 2038

    in 12 yr 6 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)

  Mar 27, 2028

  in 1 yr 10 mo

• NCENew chemical entity exclusivity (5 years)

  Sep 29, 2028

  in 2 yr 4 mo

• ODE-443Orphan-drug exclusivity (7 years)

  Sep 29, 2030

  in 4 yr 4 mo

• ODE-531Orphan-drug exclusivity (7 years)

  Mar 27, 2032

  in 5 yr 10 mo

Listed patents (6)