FDA Orange Book · active-ingredient family
Ivacaftor; lumacaftor
Ivacaftor; lumacaftor is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ORKAMBI · NDA 211358
2
Brand (NDA)
0
Generics (ANDA)
46
Listed patents
12
Exclusivity periods
Brand (NDA) products · granule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ORKAMBIRLD×3 | VERTEX PHARMS INC | NDA 211358 | — | Sep 02, 2022 | |
| ORKAMBIRLD×2 | VERTEX PHARMS INC | NDA 206038 | — | Sep 28, 2016 |
Marketing exclusivity (12)
- M-14New use / labeling-change exclusivity (3 years)
Dec 13, 2027
in 1 yr 6 mo
- ODE-408Orphan-drug exclusivity (7 years)
Sep 02, 2029
in 3 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
Mar 02, 2030
in 3 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 13, 2028
in 2 yr
- M-14New use / labeling-change exclusivity (3 years)
Dec 13, 2027
in 1 yr 6 mo
- ODE-408Orphan-drug exclusivity (7 years)
Sep 02, 2029
in 3 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
Mar 02, 2030
in 3 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 13, 2028
in 2 yr
- M-14New use / labeling-change exclusivity (3 years)
Dec 13, 2027
in 1 yr 6 mo
- ODE-408Orphan-drug exclusivity (7 years)
Sep 02, 2029
in 3 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
Mar 02, 2030
in 3 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 13, 2028
in 2 yr
Listed patents (46)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7973038 | Nov 08, 2026 | in 5 mo | U-3424 |
| 8741933 | Nov 08, 2026 | in 5 mo | U-3424 |
| 9216969 | Nov 08, 2026 | in 5 mo | Product |
| 9670163 | Dec 28, 2026 | in 6 mo | ProductU-3429 |
| 9931334 | Dec 28, 2026 | in 6 mo | ProductU-3429 |
| 8410274 | Dec 28, 2026 | in 6 mo | Product |
| 8754224 | Dec 28, 2026 | in 6 mo | SubstanceProduct |
| 9216969*PED | May 08, 2027 | in 11 mo | |
| 7973038*PED | May 08, 2027 | in 11 mo | |
| 8741933*PED | May 08, 2027 | in 11 mo | |
| 7495103 | May 20, 2027 | in 11 mo | SubstanceProduct |
| 9670163*PED | Jun 28, 2027 | in 1 yr | |
| 9931334*PED | Jun 28, 2027 | in 1 yr | |
| 8410274*PED | Jun 28, 2027 | in 1 yr | |
| 8754224*PED | Jun 28, 2027 | in 1 yr | |
| 8324242 | Aug 05, 2027 | in 1 yr 2 mo | U-3424 |
| 7495103*PED | Nov 20, 2027 | in 1 yr 5 mo | |
| 8324242*PED | Feb 05, 2028 | in 1 yr 8 mo | |
| 9150552 | Dec 04, 2028 | in 2 yr 6 mo | U-3427 |
| 12065432 | Dec 04, 2028 | in 2 yr 6 mo | U-3983 |
| 10597384 | Dec 04, 2028 | in 2 yr 6 mo | SubstanceProductU-3430 |
| 8653103 | Dec 04, 2028 | in 2 yr 6 mo | Product |
| 11052075 | Dec 04, 2028 | in 2 yr 6 mo | ProductU-3181 |
| 10076513 | Dec 04, 2028 | in 2 yr 6 mo | ProductU-2411 |
| 10597384*PED | Jun 04, 2029 | in 3 yr | |
| 12065432*PED | Jun 04, 2029 | in 3 yr | |
| 8653103*PED | Jun 04, 2029 | in 3 yr | |
| 9150552*PED | Jun 04, 2029 | in 3 yr | |
| 11052075*PED | Jun 04, 2029 | in 3 yr | |
| 10076513*PED | Jun 04, 2029 | in 3 yr | |
| 8846718 | Jul 02, 2029 | in 3 yr 1 mo | U-3427 |
| 12458635 | Aug 13, 2029 | in 3 yr 2 mo | ProductU-4335 |
| 11564916 | Aug 13, 2029 | in 3 yr 2 mo | U-3526 |
| 10646481 | Aug 13, 2029 | in 3 yr 2 mo | Product |
| 9192606 | Sep 29, 2029 | in 3 yr 4 mo | ProductU-3428 |
| 8846718*PED | Jan 02, 2030 | in 3 yr 7 mo | |
| 10646481*PED | Feb 13, 2030 | in 3 yr 9 mo | |
| 12458635*PED | Feb 13, 2030 | in 3 yr 9 mo | |
| 11564916*PED | Feb 13, 2030 | in 3 yr 9 mo | |
| 9192606*PED | Mar 29, 2030 | in 3 yr 10 mo | |
| 8716338 | Sep 20, 2030 | in 4 yr 4 mo | ProductU-3426 |
| 8507534 | Sep 20, 2030 | in 4 yr 4 mo | SubstanceProduct |
| 8993600 | Dec 11, 2030 | in 4 yr 7 mo | Product |
| 8507534*PED | Mar 20, 2031 | in 4 yr 10 mo | |
| 8716338*PED | Mar 20, 2031 | in 4 yr 10 mo | |
| 8993600*PED | Jun 11, 2031 | in 5 yr 1 mo |
Ivacaftor; lumacaftor — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
