TAFINLAR

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Mar 16, 2023

   3 yr 4 mo ago

2. Exclusivity ends · NP

   New product exclusivity (3 years)

   Mar 16, 2026

   3 mo ago

3. Today

4. Exclusivity ends · PED

   Pediatric exclusivity (adds 6 months)

   Sep 16, 2026

   in 3 mo

5. Patent 7994185 expires

   Listed drug substance patent expiration.

   Jan 20, 2030

   in 3 yr 8 mo

6. Patent 8415345 expires

   Listed drug substance patent expiration.

   Jan 20, 2030

   in 3 yr 8 mo

7. Exclusivity ends · ODE-428

   Orphan-drug exclusivity (7 years)

   Mar 16, 2030

   in 3 yr 10 mo

8. Patent 7994185*PED expires

   Listed listed patent expiration.

   Jul 20, 2030

   in 4 yr 2 mo

9. Patent 8415345*PED expires

   Listed listed patent expiration.

   Jul 20, 2030

   in 4 yr 2 mo

10. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Sep 16, 2030

    in 4 yr 4 mo

11. Patent 8703781 expires

    Listed drug substance patent expiration.

    Oct 15, 2030

    in 4 yr 5 mo

12. Patent 8703781*PED expires

    Listed listed patent expiration.

    Apr 15, 2031

    in 4 yr 11 mo

13. Patent 11504333 expires

    Listed drug product patent expiration.

    Jun 29, 2038

    in 12 yr 2 mo

14. Patent 11504333*PED expires

    Listed listed patent expiration.

    Dec 29, 2038

    in 12 yr 9 mo

Pharmaceutical detail

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

• TAFINLARBrand (NDA)

  NDA 202806 · NOVARTIS

  2013

Marketing exclusivity (4)

• NPNew product exclusivity (3 years)

  Mar 16, 2026

  3 mo ago

• PEDPediatric exclusivity (adds 6 months)

  Sep 16, 2026

  in 3 mo

• ODE-428Orphan-drug exclusivity (7 years)

  Mar 16, 2030

  in 3 yr 10 mo

• PEDPediatric exclusivity (adds 6 months)

  Sep 16, 2030

  in 4 yr 4 mo

Listed patents (8)