RECORLEV

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Dec 30, 2021

   4 yr 6 mo ago

2. Patent 10098877 expires

   Listed method-of-use patent (U-3283) expiration.

   Jan 10, 2026

   5 mo ago

3. Patent 10517868 expires

   Listed method-of-use patent (U-3283) expiration.

   Jan 10, 2026

   5 mo ago

4. Patent 10835530 expires

   Listed method-of-use patent (U-3283) expiration.

   Jan 10, 2026

   5 mo ago

5. Patent 11478471 expires

   Listed method-of-use patent (U-3283) expiration.

   Jan 10, 2026

   5 mo ago

6. Today

7. Exclusivity ends · NCE*

   FDA marketing exclusivity

   Dec 30, 2026

   in 6 mo

8. Patent 9918984 expires

   Listed method-of-use patent (U-3283) expiration.

   May 03, 2028

   in 1 yr 11 mo

9. Exclusivity ends · ODE-385

   Orphan-drug exclusivity (7 years)

   Dec 30, 2028

   in 2 yr 7 mo

10. Patent 11020393 expires

    Listed method-of-use patent (U-3282) expiration.

    Mar 02, 2040

    in 13 yr 11 mo

11. Patent 11278547 expires

    Listed method-of-use patent (U-3282) expiration.

    Mar 02, 2040

    in 13 yr 11 mo

12. Patent 11903940 expires

    Listed method-of-use patent (U-3821) expiration.

    Mar 02, 2040

    in 13 yr 11 mo

13. Patent 12377096 expires

    Listed method-of-use patent (U-4236) expiration.

    Mar 02, 2040

    in 13 yr 11 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)

• NCE*FDA marketing exclusivity

  Dec 30, 2026

  in 6 mo

• ODE-385Orphan-drug exclusivity (7 years)

  Dec 30, 2028

  in 2 yr 7 mo

Listed patents (9)