REZZAYO

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Mar 22, 2023

   3 yr 4 mo ago

2. Today

3. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Mar 22, 2028

   in 1 yr 9 mo

4. Exclusivity ends · ODE-426

   Orphan-drug exclusivity (7 years)

   Mar 22, 2030

   in 3 yr 10 mo

5. Patent 11654196 expires

   Listed drug substance patent expiration.

   Mar 02, 2032

   in 5 yr 9 mo

6. Patent 10702573 expires

   Listed drug substance patent expiration.

   Mar 14, 2033

   in 6 yr 10 mo

7. Patent 9526835 expires

   Listed drug substance patent expiration.

   Mar 14, 2033

   in 6 yr 10 mo

8. Exclusivity ends · GAIN

   Qualified infectious disease product exclusivity (adds 5 years)

   Mar 22, 2033

   in 6 yr 10 mo

9. Exclusivity ends · GAIN

   Qualified infectious disease product exclusivity (adds 5 years)

   Mar 22, 2035

   in 8 yr 11 mo

10. Patent 8722619 expires

    Listed drug substance patent expiration.

    May 09, 2036

    in 10 yr

11. Patent 11712459 expires

    Listed drug product patent expiration.

    Mar 15, 2037

    in 10 yr 11 mo

12. Patent 11819533 expires

    Listed drug substance patent expiration.

    Jul 11, 2038

    in 12 yr 3 mo

13. Patent 11197909 expires

    Listed drug substance patent expiration.

    Jul 14, 2038

    in 12 yr 3 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)

• NCENew chemical entity exclusivity (5 years)

  Mar 22, 2028

  in 1 yr 9 mo

• ODE-426Orphan-drug exclusivity (7 years)

  Mar 22, 2030

  in 3 yr 10 mo

• GAINQualified infectious disease product exclusivity (adds 5 years)

  Mar 22, 2033

  in 6 yr 10 mo

• GAINQualified infectious disease product exclusivity (adds 5 years)

  Mar 22, 2035

  in 8 yr 11 mo

Listed patents (7)