ZEJULA

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Mar 27, 2017

   9 yr 4 mo ago

2. Today

3. Exclusivity ends · ODE-277

   Orphan-drug exclusivity (7 years)

   Oct 23, 2026

   in 4 mo

4. Exclusivity ends · ODE-295

   Orphan-drug exclusivity (7 years)

   Apr 29, 2027

   in 10 mo

5. Patent 8071579 expires

   Listed method-of-use patent (U-2655) expiration.

   Aug 12, 2027

   in 1 yr 2 mo

6. Patent 8143241 expires

   Listed method-of-use patent (U-2655) expiration.

   Aug 12, 2027

   in 1 yr 2 mo

7. Patent 8436185 expires

   Listed drug substance patent expiration.

   Apr 24, 2029

   in 2 yr 11 mo

8. Patent 8071623 expires

   Listed drug substance patent expiration.

   Mar 27, 2031

   in 4 yr 10 mo

9. Patent 8859562 expires

   Listed method-of-use patent (U-2655) expiration.

   Aug 04, 2031

   in 5 yr 2 mo

10. Patent 11091459 expires

    Listed drug product patent expiration.

    Mar 27, 2038

    in 11 yr 11 mo

11. Patent 11673877 expires

    Listed drug product patent expiration.

    Mar 27, 2038

    in 11 yr 11 mo

12. Patent 11673877 expires

    Listed drug product patent expiration.

    Mar 27, 2038

    in 11 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.

• ZEJULABrand (NDA)

  NDA 214876 · GLAXOSMITHKLINE

  2023

Marketing exclusivity (2)

• ODE-277Orphan-drug exclusivity (7 years)

  Oct 23, 2026

  in 4 mo

• ODE-295Orphan-drug exclusivity (7 years)

  Apr 29, 2027

  in 10 mo

Listed patents (8)