GAVRETO

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Sep 04, 2020

   5 yr 10 mo ago

2. Today

3. Exclusivity ends · ODE-318

   Orphan-drug exclusivity (7 years)

   Sep 04, 2027

   in 1 yr 3 mo

4. Exclusivity ends · ODE-340

   Orphan-drug exclusivity (7 years)

   Dec 01, 2027

   in 1 yr 6 mo

5. Exclusivity ends · ODE-341

   Orphan-drug exclusivity (7 years)

   Dec 01, 2027

   in 1 yr 6 mo

6. Patent 10030005 expires

   Listed drug substance patent expiration.

   Nov 01, 2036

   in 10 yr 6 mo

7. Patent 10030005 expires

   Listed drug substance patent expiration.

   Nov 01, 2036

   in 10 yr 6 mo

8. Patent 11273160 expires

   Listed method-of-use patent (U-2952) expiration.

   Apr 03, 2039

   in 13 yr

9. Patent 11872192 expires

   Listed method-of-use patent (U-2952) expiration.

   Apr 03, 2039

   in 13 yr

10. Patent 11963958 expires

    Listed method-of-use patent (U-2828) expiration.

    Apr 03, 2039

    in 13 yr

11. Patent 12539303 expires

    Listed method-of-use patent (U-2828) expiration.

    Apr 03, 2039

    in 13 yr

12. Patent 12448366 expires

    Listed drug substance patent expiration.

    Jul 07, 2042

    in 16 yr 3 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 (3)

• ODE-318Orphan-drug exclusivity (7 years)

  Sep 04, 2027

  in 1 yr 3 mo

• ODE-340Orphan-drug exclusivity (7 years)

  Dec 01, 2027

  in 1 yr 6 mo

• ODE-341Orphan-drug exclusivity (7 years)

  Dec 01, 2027

  in 1 yr 6 mo

Listed patents (7)