AGAMREE

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Oct 26, 2023

   2 yr 8 mo ago

2. Today

3. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Oct 26, 2028

   in 2 yr 5 mo

4. Patent 10857161 expires

   Listed drug product patent expiration.

   May 28, 2029

   in 3 yr

5. Patent 11833159 expires

   Listed drug product patent expiration.

   May 28, 2029

   in 3 yr

6. Patent 8334279 expires

   Listed method-of-use patent (U-3747) expiration.

   May 28, 2029

   in 3 yr

7. Exclusivity ends · ODE-450

   Orphan-drug exclusivity (7 years)

   Oct 26, 2030

   in 4 yr 5 mo

8. Patent 11690853 expires

   Listed method-of-use patent (U-3747) expiration.

   Mar 07, 2033

   in 6 yr 10 mo

9. Patent 11471471 expires

   Listed method-of-use patent (U-3747) expiration.

   Mar 17, 2040

   in 13 yr 11 mo

10. Patent 12201639 expires

    Listed drug substance patent expiration.

    Mar 17, 2040

    in 13 yr 11 mo

11. Patent 11382922 expires

    Listed drug substance patent expiration.

    Jul 16, 2040

    in 14 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 (2)

• NCENew chemical entity exclusivity (5 years)

  Oct 26, 2028

  in 2 yr 5 mo

• ODE-450Orphan-drug exclusivity (7 years)

  Oct 26, 2030

  in 4 yr 5 mo

Listed patents (7)