KALYDECO

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   May 03, 2023

   3 yr 2 mo ago

2. Exclusivity ends · NPP

   New patient population exclusivity (3 years)

   May 03, 2026

   2 mo ago

3. Today

4. Patent 8354427 expires

   Listed method-of-use patent (U-3608) expiration.

   Jul 06, 2026

   in 17 d

5. Exclusivity ends · PED

   Pediatric exclusivity (adds 6 months)

   Nov 03, 2026

   in 5 mo

6. Patent 8410274 expires

   Listed drug product patent expiration.

   Dec 28, 2026

   in 6 mo

7. Patent 8754224 expires

   Listed drug substance patent expiration.

   Dec 28, 2026

   in 6 mo

8. Patent 9670163 expires

   Listed drug product patent expiration.

   Dec 28, 2026

   in 6 mo

9. Patent 8354427*PED expires

   Listed listed patent expiration.

   Jan 06, 2027

   in 7 mo

10. Patent 7495103 expires

    Listed drug substance patent expiration.

    May 20, 2027

    in 11 mo

11. Patent 8410274*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

12. Patent 8754224*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

13. Patent 9670163*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

14. Patent 8324242 expires

    Listed method-of-use patent (U-3609) expiration.

    Aug 05, 2027

    in 1 yr 2 mo

15. Patent 7495103*PED expires

    Listed listed patent expiration.

    Nov 20, 2027

    in 1 yr 5 mo

16. Patent 8324242*PED expires

    Listed listed patent expiration.

    Feb 05, 2028

    in 1 yr 8 mo

17. Exclusivity ends · M-14

    New use / labeling-change exclusivity (3 years)

    May 22, 2028

    in 1 yr 11 mo

18. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Nov 22, 2028

    in 2 yr 6 mo

19. Patent 10646481 expires

    Listed drug product patent expiration.

    Aug 13, 2029

    in 3 yr 2 mo

20. Patent 11564916 expires

    Listed method-of-use patent (U-3603) expiration.

    Aug 13, 2029

    in 3 yr 2 mo

21. Patent 12458635 expires

    Listed drug product patent expiration.

    Aug 13, 2029

    in 3 yr 2 mo

22. Patent 10646481*PED expires

    Listed listed patent expiration.

    Feb 13, 2030

    in 3 yr 9 mo

23. Patent 11564916*PED expires

    Listed listed patent expiration.

    Feb 13, 2030

    in 3 yr 9 mo

24. Patent 12458635*PED expires

    Listed listed patent expiration.

    Feb 13, 2030

    in 3 yr 9 mo

25. Exclusivity ends · ODE-435

    Orphan-drug exclusivity (7 years)

    May 03, 2030

    in 3 yr 11 mo

26. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Nov 03, 2030

    in 4 yr 5 mo

27. Patent 10272046 expires

    Listed drug product patent expiration.

    Feb 27, 2033

    in 6 yr 10 mo

28. Patent 11147770 expires

    Listed drug product patent expiration.

    Feb 27, 2033

    in 6 yr 10 mo

29. Patent 11752106 expires

    Listed drug product patent expiration.

    Feb 27, 2033

    in 6 yr 10 mo

30. Patent 12214083 expires

    Listed drug product patent expiration.

    Feb 27, 2033

    in 6 yr 10 mo

31. Patent 8883206 expires

    Listed drug product patent expiration.

    Feb 27, 2033

    in 6 yr 10 mo

32. Patent 10272046*PED expires

    Listed listed patent expiration.

    Aug 27, 2033

    in 7 yr 4 mo

33. Patent 11147770*PED expires

    Listed listed patent expiration.

    Aug 27, 2033

    in 7 yr 4 mo

34. Patent 11752106*PED expires

    Listed listed patent expiration.

    Aug 27, 2033

    in 7 yr 4 mo

35. Patent 12214083*PED expires

    Listed listed patent expiration.

    Aug 27, 2033

    in 7 yr 4 mo

36. Patent 8883206*PED expires

    Listed listed patent expiration.

    Aug 27, 2033

    in 7 yr 4 mo

Pharmaceutical detail

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

• KALYDECOBrand (NDA)

  NDA 203188 · VERTEX PHARMS

  2012

Marketing exclusivity (6)

• NPPNew patient population exclusivity (3 years)

  May 03, 2026

  2 mo ago

• PEDPediatric exclusivity (adds 6 months)

  Nov 03, 2026

  in 5 mo

• M-14New use / labeling-change exclusivity (3 years)

  May 22, 2028

  in 1 yr 11 mo

• PEDPediatric exclusivity (adds 6 months)

  Nov 22, 2028

  in 2 yr 6 mo

• ODE-435Orphan-drug exclusivity (7 years)

  May 03, 2030

  in 3 yr 11 mo

• PEDPediatric exclusivity (adds 6 months)

  Nov 03, 2030

  in 4 yr 5 mo

Listed patents (28)