Assyro AI

Orange Book product · Brand (NDA)

ALYFTREK

DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

Brand (NDA)NDA 218730RX VERTEX PHARMS INC

At a glance

Dec 20, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

43

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 20, 2024

    1 yr 6 mo ago

  2. Today

  3. Patent 8354427 expires

    Listed method-of-use patent (U-4091) expiration.

    Jul 06, 2026

    in 17 d

  4. Patent 8410274 expires

    Listed drug product patent expiration.

    Dec 28, 2026

    in 6 mo

  5. Patent 8754224 expires

    Listed drug substance patent expiration.

    Dec 28, 2026

    in 6 mo

  6. Patent 9670163 expires

    Listed drug product patent expiration.

    Dec 28, 2026

    in 6 mo

  7. Patent 9670163 expires

    Listed drug product patent expiration.

    Dec 28, 2026

    in 6 mo

  8. Patent 9931334 expires

    Listed drug product patent expiration.

    Dec 28, 2026

    in 6 mo

  9. Patent 9931334 expires

    Listed drug product patent expiration.

    Dec 28, 2026

    in 6 mo

  10. Patent 10022352 expires

    Listed drug product patent expiration.

    Apr 09, 2027

    in 10 mo

  11. Patent 10239867 expires

    Listed drug substance patent expiration.

    Apr 09, 2027

    in 10 mo

  12. Patent 10239867 expires

    Listed drug substance patent expiration.

    Apr 09, 2027

    in 10 mo

  13. Patent 11639347 expires

    Listed drug substance patent expiration.

    Apr 09, 2027

    in 10 mo

  14. Patent 11639347 expires

    Listed drug substance patent expiration.

    Apr 09, 2027

    in 10 mo

  15. Patent 9974781 expires

    Listed drug product patent expiration.

    Apr 09, 2027

    in 10 mo

  16. Patent 9974781 expires

    Listed drug product patent expiration.

    Apr 09, 2027

    in 10 mo

  17. Patent 7645789 expires

    Listed drug substance patent expiration.

    May 01, 2027

    in 11 mo

  18. Patent 8598181 expires

    Listed method-of-use patent (U-4090) expiration.

    May 01, 2027

    in 11 mo

  19. Patent 8598181 expires

    Listed method-of-use patent (U-4463) expiration.

    May 01, 2027

    in 11 mo

  20. Patent 8623905 expires

    Listed drug substance patent expiration.

    May 01, 2027

    in 11 mo

  21. Patent 7495103 expires

    Listed drug substance patent expiration.

    May 20, 2027

    in 11 mo

  22. Patent 7776905 expires

    Listed drug substance patent expiration.

    Jun 03, 2027

    in 1 yr

  23. Patent 8324242 expires

    Listed method-of-use patent (U-4090) expiration.

    Aug 05, 2027

    in 1 yr 2 mo

  24. Patent 8324242 expires

    Listed method-of-use patent (U-4464) expiration.

    Aug 05, 2027

    in 1 yr 2 mo

  25. Patent 8415387 expires

    Listed method-of-use patent (U-4082) expiration.

    Nov 12, 2027

    in 1 yr 5 mo

  26. Patent 8415387 expires

    Listed method-of-use patent (U-4463) expiration.

    Nov 12, 2027

    in 1 yr 5 mo

  27. Patent 10646481 expires

    Listed drug product patent expiration.

    Aug 13, 2029

    in 3 yr 2 mo

  28. Patent 11564916 expires

    Listed method-of-use patent (U-4095) expiration.

    Aug 13, 2029

    in 3 yr 2 mo

  29. Patent 11564916 expires

    Listed method-of-use patent (U-4466) expiration.

    Aug 13, 2029

    in 3 yr 2 mo

  30. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Dec 20, 2029

    in 3 yr 7 mo

  31. Patent 10081621 expires

    Listed drug product patent expiration.

    Mar 25, 2031

    in 4 yr 10 mo

  32. Patent 10081621 expires

    Listed drug product patent expiration.

    Mar 25, 2031

    in 4 yr 10 mo

  33. Patent 11578062 expires

    Listed drug product patent expiration.

    Mar 25, 2031

    in 4 yr 10 mo

  34. Patent 11578062 expires

    Listed drug product patent expiration.

    Mar 25, 2031

    in 4 yr 10 mo

  35. Patent RE50453 expires

    Listed drug substance patent expiration.

    Jul 10, 2031

    in 5 yr 2 mo

  36. Exclusivity ends · ODE-526

    Orphan-drug exclusivity (7 years)

    Dec 20, 2031

    in 5 yr 7 mo

  37. Patent 10047053 expires

    Listed drug substance patent expiration.

    May 17, 2032

    in 6 yr

  38. Patent 8865902 expires

    Listed drug substance patent expiration.

    May 17, 2032

    in 6 yr

  39. Patent 9181192 expires

    Listed drug substance patent expiration.

    May 17, 2032

    in 6 yr

  40. Patent 9181192 expires

    Listed drug substance patent expiration.

    May 17, 2032

    in 6 yr

  41. Patent 9512079 expires

    Listed drug substance patent expiration.

    May 17, 2032

    in 6 yr

  42. Patent 9512079 expires

    Listed drug substance patent expiration.

    May 17, 2032

    in 6 yr

  43. Exclusivity ends · ODE-536

    Orphan-drug exclusivity (7 years)

    Mar 27, 2033

    in 6 yr 10 mo

  44. Patent 11066417 expires

    Listed drug substance patent expiration.

    Feb 14, 2039

    in 12 yr 10 mo

  45. Patent 11866450 expires

    Listed method-of-use patent (U-4082) expiration.

    Feb 14, 2039

    in 12 yr 10 mo

  46. Patent 11866450 expires

    Listed method-of-use patent (U-4463) expiration.

    Feb 14, 2039

    in 12 yr 10 mo

  47. Patent 11873300 expires

    Listed drug substance patent expiration.

    Aug 13, 2040

    in 14 yr 4 mo

  48. Patent 11873300 expires

    Listed drug substance patent expiration.

    Aug 13, 2040

    in 14 yr 4 mo

Pharmaceutical detail

Active ingredient

DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

Strength

50MG;20MG;EQ 4MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 218730

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

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)

    Dec 20, 2029

    in 3 yr 7 mo

  • ODE-526Orphan-drug exclusivity (7 years)

    Dec 20, 2031

    in 5 yr 7 mo

  • ODE-536Orphan-drug exclusivity (7 years)

    Mar 27, 2033

    in 6 yr 10 mo

Listed patents (43)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8354427Jul 06, 2026in 17 d
U-4091
8410274Dec 28, 2026in 6 mo
Product
8754224Dec 28, 2026in 6 mo
SubstanceProduct
9670163Dec 28, 2026in 6 mo
ProductU-4080
9670163Dec 28, 2026in 6 mo
ProductU-4470
9931334Dec 28, 2026in 6 mo
ProductU-4080
9931334Dec 28, 2026in 6 mo
ProductU-4469
10022352Apr 09, 2027in 10 mo
ProductU-4081
10239867Apr 09, 2027in 10 mo
SubstanceProductU-4090
10239867Apr 09, 2027in 10 mo
SubstanceProductU-4464
11639347Apr 09, 2027in 10 mo
SubstanceProductU-4090
11639347Apr 09, 2027in 10 mo
SubstanceProductU-4464
9974781Apr 09, 2027in 10 mo
ProductU-4082
9974781Apr 09, 2027in 10 mo
ProductU-4463
7645789May 01, 2027in 11 mo
SubstanceProduct
8598181May 01, 2027in 11 mo
U-4090
8598181May 01, 2027in 11 mo
U-4463
8623905May 01, 2027in 11 mo
SubstanceProduct
7495103May 20, 2027in 11 mo
SubstanceProduct
7776905Jun 03, 2027in 1 yr
SubstanceProduct
8324242Aug 05, 2027in 1 yr 2 mo
U-4090
8324242Aug 05, 2027in 1 yr 2 mo
U-4464
8415387Nov 12, 2027in 1 yr 5 mo
U-4082
8415387Nov 12, 2027in 1 yr 5 mo
U-4463
10646481Aug 13, 2029in 3 yr 2 mo
Product
11564916Aug 13, 2029in 3 yr 2 mo
U-4095
11564916Aug 13, 2029in 3 yr 2 mo
U-4466
10081621Mar 25, 2031in 4 yr 10 mo
ProductU-4087
10081621Mar 25, 2031in 4 yr 10 mo
ProductU-4468
11578062Mar 25, 2031in 4 yr 10 mo
ProductU-4096
11578062Mar 25, 2031in 4 yr 10 mo
ProductU-4465
RE50453Jul 10, 2031in 5 yr 2 mo
SubstanceProduct
10047053May 17, 2032in 6 yr
Substance
8865902May 17, 2032in 6 yr
SubstanceProduct
9181192May 17, 2032in 6 yr
SubstanceProductU-4094
9181192May 17, 2032in 6 yr
SubstanceProductU-4472
9512079May 17, 2032in 6 yr
SubstanceProductU-4098
9512079May 17, 2032in 6 yr
SubstanceProductU-4471
11066417Feb 14, 2039in 12 yr 10 mo
SubstanceProduct
11866450Feb 14, 2039in 12 yr 10 mo
U-4082
11866450Feb 14, 2039in 12 yr 10 mo
U-4463
11873300Aug 13, 2040in 14 yr 4 mo
SubstanceProductU-4083
11873300Aug 13, 2040in 14 yr 4 mo
SubstanceProductU-4462
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.