OMLONTI

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Sep 22, 2022

   3 yr 10 mo ago

2. Today

3. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Sep 22, 2027

   in 1 yr 3 mo

4. Patent 8648097 expires

   Listed drug substance patent expiration.

   Oct 13, 2029

   in 3 yr 4 mo

5. Patent 8685986 expires

   Listed drug product patent expiration.

   Oct 13, 2029

   in 3 yr 4 mo

6. Patent 10179127 expires

   Listed drug product patent expiration.

   Jan 08, 2035

   in 8 yr 8 mo

7. Patent 10702511 expires

   Listed drug product patent expiration.

   Jan 08, 2035

   in 8 yr 8 mo

8. Patent 10765750 expires

   Listed drug product patent expiration.

   Jan 08, 2035

   in 8 yr 8 mo

9. Patent 11197849 expires

   Listed drug product patent expiration.

   Jan 08, 2035

   in 8 yr 8 mo

10. Patent 11793798 expires

    Listed drug product patent expiration.

    Jan 08, 2035

    in 8 yr 8 mo

11. Patent 12295946 expires

    Listed drug product patent expiration.

    Jan 08, 2035

    in 8 yr 8 mo

12. Patent 9415038 expires

    Listed drug product patent expiration.

    Jan 08, 2035

    in 8 yr 8 mo

13. Patent RE48183 expires

    Listed drug product patent expiration.

    Jan 08, 2035

    in 8 yr 8 mo

14. Patent 10774072 expires

    Listed drug substance patent expiration.

    Jun 10, 2035

    in 9 yr 1 mo

15. Patent 12290511 expires

    Listed method-of-use patent (U-3454) expiration.

    Dec 27, 2038

    in 12 yr 8 mo

16. Patent 11666563 expires

    Listed method-of-use patent (U-3454) expiration.

    Jul 16, 2039

    in 13 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 (1)

• NCENew chemical entity exclusivity (5 years)

  Sep 22, 2027

  in 1 yr 3 mo

Listed patents (13)