KALYDECO

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Apr 29, 2019

   7 yr 3 mo ago

2. Exclusivity ends · ODE-236

   Orphan-drug exclusivity (7 years)

   Apr 29, 2026

   2 mo ago

3. Today

4. Patent 8354427 expires

   Listed method-of-use patent (U-1311) expiration.

   Jul 06, 2026

   in 17 d

5. Patent 8354427 expires

   Listed method-of-use patent (U-1905) expiration.

   Jul 06, 2026

   in 17 d

6. Patent 8354427 expires

   Listed method-of-use patent (U-2964) expiration.

   Jul 06, 2026

   in 17 d

7. Exclusivity ends · PED

   Pediatric exclusivity (adds 6 months)

   Oct 29, 2026

   in 4 mo

8. Patent 8410274 expires

   Listed drug product patent expiration.

   Dec 28, 2026

   in 6 mo

9. Patent 8754224 expires

   Listed drug substance patent expiration.

   Dec 28, 2026

   in 6 mo

10. Patent 9670163 expires

    Listed drug product patent expiration.

    Dec 28, 2026

    in 6 mo

11. Patent 9670163 expires

    Listed drug product patent expiration.

    Dec 28, 2026

    in 6 mo

12. Patent 8354427*PED expires

    Listed listed patent expiration.

    Jan 06, 2027

    in 7 mo

13. Patent 7495103 expires

    Listed drug substance patent expiration.

    May 20, 2027

    in 11 mo

14. Patent 8410274*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

15. Patent 8754224*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

16. Patent 9670163*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

17. Patent 8324242 expires

    Listed method-of-use patent (U-1311) expiration.

    Aug 05, 2027

    in 1 yr 2 mo

18. Patent 8324242 expires

    Listed method-of-use patent (U-1906) expiration.

    Aug 05, 2027

    in 1 yr 2 mo

19. Patent 8324242 expires

    Listed method-of-use patent (U-2963) expiration.

    Aug 05, 2027

    in 1 yr 2 mo

20. Patent 7495103*PED expires

    Listed listed patent expiration.

    Nov 20, 2027

    in 1 yr 5 mo

21. Exclusivity ends · ODE-338

    Orphan-drug exclusivity (7 years)

    Dec 21, 2027

    in 1 yr 6 mo

22. Patent 8324242*PED expires

    Listed listed patent expiration.

    Feb 05, 2028

    in 1 yr 8 mo

23. Exclusivity ends · M-14

    New use / labeling-change exclusivity (3 years)

    May 22, 2028

    in 1 yr 11 mo

24. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Jun 21, 2028

    in 2 yr

25. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Nov 22, 2028

    in 2 yr 6 mo

26. Patent 10646481 expires

    Listed drug product patent expiration.

    Aug 13, 2029

    in 3 yr 2 mo

27. Patent 11564916 expires

    Listed method-of-use patent (U-3528) expiration.

    Aug 13, 2029

    in 3 yr 2 mo

28. Patent 12458635 expires

    Listed drug product patent expiration.

    Aug 13, 2029

    in 3 yr 2 mo

29. Patent 10646481*PED expires

    Listed listed patent expiration.

    Feb 13, 2030

    in 3 yr 9 mo

30. Patent 11564916*PED expires

    Listed listed patent expiration.

    Feb 13, 2030

    in 3 yr 9 mo

31. Patent 12458635*PED expires

    Listed listed patent expiration.

    Feb 13, 2030

    in 3 yr 9 mo

32. Patent 10272046 expires

    Listed drug product patent expiration.

    Feb 27, 2033

    in 6 yr 10 mo

33. Patent 11147770 expires

    Listed drug product patent expiration.

    Feb 27, 2033

    in 6 yr 10 mo

34. Patent 11752106 expires

    Listed drug product patent expiration.

    Feb 27, 2033

    in 6 yr 10 mo

35. Patent 12214083 expires

    Listed drug product patent expiration.

    Feb 27, 2033

    in 6 yr 10 mo

36. Patent 8883206 expires

    Listed drug product patent expiration.

    Feb 27, 2033

    in 6 yr 10 mo

37. Patent 10272046*PED expires

    Listed listed patent expiration.

    Aug 27, 2033

    in 7 yr 4 mo

38. Patent 11147770*PED expires

    Listed listed patent expiration.

    Aug 27, 2033

    in 7 yr 4 mo

39. Patent 11752106*PED expires

    Listed listed patent expiration.

    Aug 27, 2033

    in 7 yr 4 mo

40. Patent 12214083*PED expires

    Listed listed patent expiration.

    Aug 27, 2033

    in 7 yr 4 mo

41. 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)

• ODE-236Orphan-drug exclusivity (7 years)

  Apr 29, 2026

  2 mo ago

• PEDPediatric exclusivity (adds 6 months)

  Oct 29, 2026

  in 4 mo

• ODE-338Orphan-drug exclusivity (7 years)

  Dec 21, 2027

  in 1 yr 6 mo

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

  May 22, 2028

  in 1 yr 11 mo

• PEDPediatric exclusivity (adds 6 months)

  Jun 21, 2028

  in 2 yr

• PEDPediatric exclusivity (adds 6 months)

  Nov 22, 2028

  in 2 yr 6 mo

Listed patents (33)