AMONDYS 45

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Feb 25, 2021

   5 yr 5 mo ago

2. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Feb 25, 2026

   4 mo ago

3. Today

4. Exclusivity ends · ODE-347

   Orphan-drug exclusivity (7 years)

   Feb 25, 2028

   in 1 yr 9 mo

5. Patent RE48960 expires

   Listed drug substance patent expiration.

   Feb 16, 2029

   in 2 yr 8 mo

6. Patent RE48960 expires

   Listed drug substance patent expiration.

   Feb 16, 2029

   in 2 yr 8 mo

7. Patent 10287586 expires

   Listed drug substance patent expiration.

   Nov 12, 2030

   in 4 yr 6 mo

8. Patent 10781450 expires

   Listed method-of-use patent (U-3089) expiration.

   Nov 12, 2030

   in 4 yr 6 mo

9. Patent 9228187 expires

   Listed drug substance patent expiration.

   Nov 12, 2030

   in 4 yr 6 mo

10. Patent 9758783 expires

    Listed method-of-use patent (U-3088) expiration.

    Nov 12, 2030

    in 4 yr 6 mo

11. Patent 9758783 expires

    Listed method-of-use patent (U-3089) expiration.

    Nov 12, 2030

    in 4 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 (2)

• NCENew chemical entity exclusivity (5 years)

  Feb 25, 2026

  4 mo ago

• ODE-347Orphan-drug exclusivity (7 years)

  Feb 25, 2028

  in 1 yr 9 mo

Listed patents (7)