QULIPTA

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Sep 28, 2021

   4 yr 10 mo ago

2. Exclusivity ends · I-909

   New indication exclusivity (3 years)

   Apr 17, 2026

   2 mo ago

3. Today

4. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Sep 28, 2026

   in 3 mo

5. Patent 9499545 expires

   Listed drug substance patent expiration.

   Nov 10, 2031

   in 5 yr 6 mo

6. Patent 9850246 expires

   Listed drug substance patent expiration.

   Mar 13, 2033

   in 6 yr 10 mo

7. Patent 10117836 expires

   Listed drug product patent expiration.

   Jan 30, 2035

   in 8 yr 9 mo

8. Patent 8754096 expires

   Listed drug substance patent expiration.

   Sep 28, 2035

   in 9 yr 5 mo

9. Patent 12383545 expires

   Listed method-of-use patent (U-3534) expiration.

   Jun 06, 2039

   in 13 yr 2 mo

10. Patent 12090148 expires

    Listed method-of-use patent (U-3534) expiration.

    Jul 29, 2041

    in 15 yr 4 mo

11. Patent 12465598 expires

    Listed method-of-use patent (U-4355) expiration.

    Sep 27, 2042

    in 16 yr 6 mo

12. Patent 12622897 expires

    Listed method-of-use patent (U-4536) expiration.

    Sep 27, 2042

    in 16 yr 6 mo

13. Patent 12350259 expires

    Listed method-of-use patent (U-4234) expiration.

    Feb 27, 2043

    in 16 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)

• I-909New indication exclusivity (3 years)

  Apr 17, 2026

  2 mo ago

• NCENew chemical entity exclusivity (5 years)

  Sep 28, 2026

  in 3 mo

Listed patents (9)