FDA Orange Book · active-ingredient family
Ivacaftor; ivacaftor, tezacaftor
Ivacaftor; ivacaftor, tezacaftor is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SYMDEKO (COPACKAGED) · NDA 210491
1
Brand (NDA)
0
Generics (ANDA)
26
Listed patents
4
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SYMDEKO (COPACKAGED)RLD×2 | VERTEX PHARMS INC | NDA 210491 | — | Jun 21, 2019 |
Marketing exclusivity (4)
- ODE-247Orphan-drug exclusivity (7 years)
Jun 21, 2026
in 2 d
- ODE-335Orphan-drug exclusivity (7 years)
Dec 21, 2027
in 1 yr 6 mo
- ODE-247Orphan-drug exclusivity (7 years)
Jun 21, 2026
in 2 d
- ODE-335Orphan-drug exclusivity (7 years)
Dec 21, 2027
in 1 yr 6 mo
Listed patents (26)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8354427 | Jul 06, 2026 | in 17 d | U-3021 |
| 9670163 | Dec 28, 2026 | in 6 mo | ProductU-2246 |
| 9931334 | Dec 28, 2026 | in 6 mo | ProductU-2575 |
| 8410274 | Dec 28, 2026 | in 6 mo | Product |
| 8754224 | Dec 28, 2026 | in 6 mo | SubstanceProduct |
| 10239867 | Apr 09, 2027 | in 10 mo | SubstanceProductU-2512 |
| 10022352 | Apr 09, 2027 | in 10 mo | ProductU-2343 |
| 11639347 | Apr 09, 2027 | in 10 mo | SubstanceProductU-2569 |
| 9974781 | Apr 09, 2027 | in 10 mo | ProductU-2574 |
| 8598181 | May 01, 2027 | in 11 mo | U-2246 |
| 7645789 | May 01, 2027 | in 11 mo | SubstanceProduct |
| 8623905 | May 01, 2027 | in 11 mo | SubstanceProduct |
| 7495103 | May 20, 2027 | in 11 mo | SubstanceProduct |
| 7776905 | Jun 03, 2027 | in 1 yr | SubstanceProduct |
| 8324242 | Aug 05, 2027 | in 1 yr 2 mo | U-2246 |
| 8415387 | Nov 12, 2027 | in 1 yr 5 mo | U-2246 |
| 12458635 | Aug 13, 2029 | in 3 yr 2 mo | ProductU-4336 |
| 11564916 | Aug 13, 2029 | in 3 yr 2 mo | U-3527 |
| 10646481 | Aug 13, 2029 | in 3 yr 2 mo | Product |
| 11578062 | Mar 25, 2031 | in 4 yr 10 mo | ProductU-3545 |
| 10081621 | Mar 25, 2031 | in 4 yr 10 mo | ProductU-3024 |
| RE50453 | Jul 10, 2031 | in 5 yr 2 mo | SubstanceProduct |
| 10058546 | Jul 15, 2033 | in 7 yr 2 mo | U-3022 |
| 9012496 | Jul 15, 2033 | in 7 yr 2 mo | U-2248 |
| 10206877 | Apr 14, 2035 | in 8 yr 11 mo | ProductU-3026 |
| 11951212 | Apr 14, 2035 | in 8 yr 11 mo | ProductU-3894 |
Ivacaftor; ivacaftor, tezacaftor — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
