FILSPARI

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Feb 17, 2023

   3 yr 5 mo ago

2. Today

3. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Feb 17, 2028

   in 1 yr 8 mo

4. Exclusivity ends · ODE-389

   Orphan-drug exclusivity (7 years)

   Feb 17, 2030

   in 3 yr 9 mo

5. Patent 9662312 expires

   Listed method-of-use patent (U-4495) expiration.

   Mar 29, 2030

   in 3 yr 10 mo

6. Patent 9993461 expires

   Listed method-of-use patent (U-3269) expiration.

   Mar 29, 2030

   in 3 yr 10 mo

7. Patent 9993461 expires

   Listed method-of-use patent (U-3993) expiration.

   Mar 29, 2030

   in 3 yr 10 mo

8. Patent 9993461 expires

   Listed method-of-use patent (U-4495) expiration.

   Mar 29, 2030

   in 3 yr 10 mo

9. Exclusivity ends · ODE-493

   Orphan-drug exclusivity (7 years)

   Sep 05, 2031

   in 5 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)

• NCENew chemical entity exclusivity (5 years)

  Feb 17, 2028

  in 1 yr 8 mo

• ODE-389Orphan-drug exclusivity (7 years)

  Feb 17, 2030

  in 3 yr 9 mo

• ODE-493Orphan-drug exclusivity (7 years)

  Sep 05, 2031

  in 5 yr 3 mo

Listed patents (4)