VANFLYTA

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Jul 20, 2023

   3 yr ago

2. Today

3. Patent 8129374 expires

   Listed method-of-use patent (U-3661) expiration.

   Mar 16, 2027

   in 9 mo

4. Patent 8557810 expires

   Listed drug product patent expiration.

   Mar 16, 2027

   in 9 mo

5. Patent 8883783 expires

   Listed drug substance patent expiration.

   Mar 16, 2027

   in 9 mo

6. Patent 9585892 expires

   Listed method-of-use patent (U-3661) expiration.

   Mar 16, 2027

   in 9 mo

7. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Jul 20, 2028

   in 2 yr 1 mo

8. Patent 7820657 expires

   Listed drug substance patent expiration.

   Sep 26, 2028

   in 2 yr 4 mo

9. Patent 7968543 expires

   Listed drug product patent expiration.

   Aug 15, 2029

   in 3 yr 2 mo

10. Patent 8865710 expires

    Listed drug product patent expiration.

    Aug 15, 2029

    in 3 yr 2 mo

11. Patent 8836218 expires

    Listed method-of-use patent (U-3661) expiration.

    Mar 23, 2030

    in 3 yr 10 mo

12. Patent 9555040 expires

    Listed method-of-use patent (U-3661) expiration.

    May 14, 2030

    in 4 yr

13. Exclusivity ends · ODE-437

    Orphan-drug exclusivity (7 years)

    Jul 20, 2030

    in 4 yr 2 mo

14. Patent 8357690 expires

    Listed method-of-use patent (U-3661) expiration.

    Feb 26, 2031

    in 4 yr 9 mo

15. Patent 9675549 expires

    Listed drug product patent expiration.

    Sep 30, 2033

    in 7 yr 5 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)

  Jul 20, 2028

  in 2 yr 1 mo

• ODE-437Orphan-drug exclusivity (7 years)

  Jul 20, 2030

  in 4 yr 2 mo

Listed patents (11)