JAYPIRCA

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Jan 27, 2023

   3 yr 5 mo ago

2. Today

3. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Jan 27, 2028

   in 1 yr 8 mo

4. Exclusivity ends · I-981

   New indication exclusivity (3 years)

   Dec 02, 2028

   in 2 yr 6 mo

5. Exclusivity ends · ODE-424

   Orphan-drug exclusivity (7 years)

   Jan 27, 2030

   in 3 yr 8 mo

6. Exclusivity ends · ODE-451

   Orphan-drug exclusivity (7 years)

   Dec 01, 2030

   in 4 yr 6 mo

7. Exclusivity ends · ODE-518

   Orphan-drug exclusivity (7 years)

   Dec 03, 2032

   in 6 yr 7 mo

8. Patent 10342780 expires

   Listed drug substance patent expiration.

   Dec 16, 2036

   in 10 yr 8 mo

9. Patent 10464905 expires

   Listed method-of-use patent (U-3518) expiration.

   Dec 16, 2036

   in 10 yr 8 mo

10. Patent 10464905 expires

    Listed method-of-use patent (U-4362) expiration.

    Dec 16, 2036

    in 10 yr 8 mo

11. Patent 10695323 expires

    Listed drug substance patent expiration.

    Dec 16, 2036

    in 10 yr 8 mo

12. Patent 10695323 expires

    Listed drug substance patent expiration.

    Dec 16, 2036

    in 10 yr 8 mo

13. Patent 10918622 expires

    Listed method-of-use patent (U-3518) expiration.

    Dec 16, 2036

    in 10 yr 8 mo

14. Patent 10918622 expires

    Listed method-of-use patent (U-4362) expiration.

    Dec 16, 2036

    in 10 yr 8 mo

15. Patent 12220401 expires

    Listed drug substance patent expiration.

    Dec 16, 2036

    in 10 yr 8 mo

16. Patent 12220401 expires

    Listed drug substance patent expiration.

    Dec 16, 2036

    in 10 yr 8 mo

17. Patent 12268666 expires

    Listed drug product patent expiration.

    Jul 29, 2039

    in 13 yr 4 mo

18. Patent 12109193 expires

    Listed drug product patent expiration.

    Sep 14, 2041

    in 15 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 (5)

• NCENew chemical entity exclusivity (5 years)

  Jan 27, 2028

  in 1 yr 8 mo

• I-981New indication exclusivity (3 years)

  Dec 02, 2028

  in 2 yr 6 mo

• ODE-424Orphan-drug exclusivity (7 years)

  Jan 27, 2030

  in 3 yr 8 mo

• ODE-451Orphan-drug exclusivity (7 years)

  Dec 01, 2030

  in 4 yr 6 mo

• ODE-518Orphan-drug exclusivity (7 years)

  Dec 03, 2032

  in 6 yr 7 mo

Listed patents (11)