AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   May 08, 2025

   1 yr 2 mo ago

2. Today

3. Patent 7897792 expires

   Listed drug substance patent expiration.

   Feb 09, 2027

   in 8 mo

4. Patent 8247411 expires

   Listed drug substance patent expiration.

   Apr 17, 2028

   in 1 yr 10 mo

5. Patent 7928109 expires

   Listed drug substance patent expiration.

   Aug 21, 2029

   in 3 yr 3 mo

6. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   May 08, 2030

   in 3 yr 11 mo

7. Exclusivity ends · ODE-525

   Orphan-drug exclusivity (7 years)

   May 08, 2032

   in 6 yr

8. Patent 11400090 expires

   Listed method-of-use patent (U-4196) expiration.

   Oct 29, 2038

   in 12 yr 7 mo

9. Patent 11517573 expires

   Listed method-of-use patent (U-4196) expiration.

   Sep 11, 2040

   in 14 yr 5 mo

10. Patent 11517573 expires

    Listed method-of-use patent (U-4205) expiration.

    Sep 11, 2040

    in 14 yr 5 mo

11. Patent 11873296 expires

    Listed drug product patent expiration.

    Dec 29, 2042

    in 16 yr 9 mo

12. Patent 12509450 expires

    Listed drug product patent expiration.

    Dec 29, 2042

    in 16 yr 9 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)

  May 08, 2030

  in 3 yr 11 mo

• ODE-525Orphan-drug exclusivity (7 years)

  May 08, 2032

  in 6 yr

Listed patents (8)