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FDA Orange Book · active-ingredient family

Deutivacaftor; tezacaftor; vanzacaftor calcium

Deutivacaftor; tezacaftor; vanzacaftor calcium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ALYFTREK · NDA 218730

1

Brand (NDA)

0

Generics (ANDA)

33

Listed patents

6

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
ALYFTREKRLD×2VERTEX PHARMS INCNDA 218730—Dec 20, 2024

Marketing exclusivity (6)

  • 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

  • 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 (33)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8354427Jul 06, 2026in 17 d
U-4091
9670163Dec 28, 2026in 6 mo
ProductU-4080
9931334Dec 28, 2026in 6 mo
ProductU-4080
8754224Dec 28, 2026in 6 mo
SubstanceProduct
8410274Dec 28, 2026in 6 mo
Product
10022352Apr 09, 2027in 10 mo
ProductU-4081
9974781Apr 09, 2027in 10 mo
ProductU-4082
10239867Apr 09, 2027in 10 mo
SubstanceProductU-4090
11639347Apr 09, 2027in 10 mo
SubstanceProductU-4090
8598181May 01, 2027in 11 mo
U-4090
7645789May 01, 2027in 11 mo
SubstanceProduct
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
8415387Nov 12, 2027in 1 yr 5 mo
U-4082
11564916Aug 13, 2029in 3 yr 2 mo
U-4095
10646481Aug 13, 2029in 3 yr 2 mo
Product
10081621Mar 25, 2031in 4 yr 10 mo
ProductU-4087
11578062Mar 25, 2031in 4 yr 10 mo
ProductU-4096
RE50453Jul 10, 2031in 5 yr 2 mo
SubstanceProduct
9181192May 17, 2032in 6 yr
SubstanceProductU-4094
9512079May 17, 2032in 6 yr
SubstanceProductU-4098
8865902May 17, 2032in 6 yr
SubstanceProduct
10047053May 17, 2032in 6 yr
Substance
9012496Jul 15, 2033in 7 yr 2 mo
U-4097
10058546Jul 15, 2033in 7 yr 2 mo
U-4218
11951212Apr 14, 2035in 8 yr 11 mo
ProductU-4089
10206877Apr 14, 2035in 8 yr 11 mo
ProductU-4092
11866450Feb 14, 2039in 12 yr 10 mo
U-4082
11066417Feb 14, 2039in 12 yr 10 mo
SubstanceProduct
11873300Aug 13, 2040in 14 yr 4 mo
SubstanceProductU-4083
12186306Jan 10, 2043in 16 yr 10 mo
U-4088

Deutivacaftor; tezacaftor; vanzacaftor calcium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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