KOSELUGO

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Apr 10, 2020

   6 yr 3 mo ago

2. Patent 8178693 expires

   Listed drug substance patent expiration.

   Mar 13, 2026

   3 mo ago

3. Today

4. Patent 9156795 expires

   Listed drug substance patent expiration.

   Dec 12, 2026

   in 6 mo

5. Patent 9562017 expires

   Listed drug substance patent expiration.

   Dec 12, 2026

   in 6 mo

6. Exclusivity ends · ODE-288

   Orphan-drug exclusivity (7 years)

   Apr 10, 2027

   in 10 mo

7. Patent 7425637 expires

   Listed drug substance patent expiration.

   Mar 13, 2028

   in 1 yr 9 mo

8. Exclusivity ends · NPP

   New patient population exclusivity (3 years)

   Sep 10, 2028

   in 2 yr 3 mo

9. Exclusivity ends · NPP

   New patient population exclusivity (3 years)

   Nov 19, 2028

   in 2 yr 5 mo

10. Patent 11813246 expires

    Listed drug product patent expiration.

    Mar 26, 2029

    in 2 yr 10 mo

11. Patent 12220403 expires

    Listed drug product patent expiration.

    Mar 26, 2029

    in 2 yr 10 mo

12. Patent 12318367 expires

    Listed drug product patent expiration.

    Mar 26, 2029

    in 2 yr 10 mo

13. Patent 12364684 expires

    Listed method-of-use patent (U-4357) expiration.

    Mar 26, 2029

    in 2 yr 10 mo

14. Exclusivity ends · ODE-545

    Orphan-drug exclusivity (7 years)

    Nov 19, 2032

    in 6 yr 6 mo

Pharmaceutical detail

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

• KOSELUGOBrand (NDA)

  NDA 219943 · ASTRAZENECA

  2025

Marketing exclusivity (4)

• ODE-288Orphan-drug exclusivity (7 years)

  Apr 10, 2027

  in 10 mo

• NPPNew patient population exclusivity (3 years)

  Sep 10, 2028

  in 2 yr 3 mo

• NPPNew patient population exclusivity (3 years)

  Nov 19, 2028

  in 2 yr 5 mo

• ODE-545Orphan-drug exclusivity (7 years)

  Nov 19, 2032

  in 6 yr 6 mo

Listed patents (8)