TEPMETKO

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Feb 03, 2021

   5 yr 5 mo ago

2. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Feb 03, 2026

   5 mo ago

3. Today

4. Exclusivity ends · ODE-325

   Orphan-drug exclusivity (7 years)

   Feb 03, 2028

   in 1 yr 8 mo

5. Patent 9284300 expires

   Listed drug product patent expiration.

   Apr 29, 2028

   in 1 yr 11 mo

6. Patent 8921357 expires

   Listed drug substance patent expiration.

   May 30, 2028

   in 2 yr

7. Patent 8658643 expires

   Listed method-of-use patent (U-3077) expiration.

   Jul 04, 2028

   in 2 yr 1 mo

8. Patent 9062029 expires

   Listed drug product patent expiration.

   Jul 04, 2028

   in 2 yr 1 mo

9. Patent 9403799 expires

   Listed method-of-use patent (U-3077) expiration.

   Jul 04, 2028

   in 2 yr 1 mo

10. Patent 8927540 expires

    Listed method-of-use patent (U-3078) expiration.

    Jul 21, 2028

    in 2 yr 1 mo

11. Patent 8329692 expires

    Listed drug substance patent expiration.

    Oct 30, 2029

    in 3 yr 5 mo

12. Patent 8580781 expires

    Listed drug substance patent expiration.

    Mar 19, 2030

    in 3 yr 10 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 03, 2026

  5 mo ago

• ODE-325Orphan-drug exclusivity (7 years)

  Feb 03, 2028

  in 1 yr 8 mo

Listed patents (8)