TUKYSA

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Apr 17, 2020

   6 yr 3 mo ago

2. Exclusivity ends · I-906

   New indication exclusivity (3 years)

   Jan 19, 2026

   5 mo ago

3. Today

4. Exclusivity ends · ODE-309

   Orphan-drug exclusivity (7 years)

   Apr 17, 2027

   in 10 mo

5. Patent 9693989 expires

   Listed drug product patent expiration.

   May 09, 2027

   in 11 mo

6. Exclusivity ends · ODE-422

   Orphan-drug exclusivity (7 years)

   Jan 19, 2030

   in 3 yr 8 mo

7. Patent 9457093 expires

   Listed drug product patent expiration.

   Oct 12, 2032

   in 6 yr 5 mo

8. Patent 11504370 expires

   Listed method-of-use patent (U-2788) expiration.

   Mar 25, 2033

   in 6 yr 10 mo

9. Patent 8648087 expires

   Listed drug substance patent expiration.

   Apr 17, 2034

   in 7 yr 11 mo

10. Patent 11207324 expires

    Listed method-of-use patent (U-3783) expiration.

    Apr 27, 2038

    in 12 yr

11. Patent 11666572 expires

    Listed method-of-use patent (U-3783) expiration.

    Apr 27, 2038

    in 12 yr

12. Patent 12048698 expires

    Listed method-of-use patent (U-3783) expiration.

    Apr 27, 2038

    in 12 yr

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 (3)

• I-906New indication exclusivity (3 years)

  Jan 19, 2026

  5 mo ago

• ODE-309Orphan-drug exclusivity (7 years)

  Apr 17, 2027

  in 10 mo

• ODE-422Orphan-drug exclusivity (7 years)

  Jan 19, 2030

  in 3 yr 8 mo

Listed patents (7)