Orange Book product · Brand (NDA)
KALYDECO
IVACAFTOR
At a glance
Jan 31, 2012
Approved
Brand (NDA)
Application
Not listed
TE code
20
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 31, 2012
14 yr 7 mo ago
Today
Patent 8354427 expires
Listed method-of-use patent (U-1905) expiration.
Jul 06, 2026
in 17 d
Patent 8354427 expires
Listed method-of-use patent (U-1311) expiration.
Jul 06, 2026
in 17 d
Patent 8410274 expires
Listed drug product patent expiration.
Dec 28, 2026
in 6 mo
Patent 8754224 expires
Listed drug substance patent expiration.
Dec 28, 2026
in 6 mo
Patent 9670163 expires
Listed drug product patent expiration.
Dec 28, 2026
in 6 mo
Patent 8354427*PED expires
Listed listed patent expiration.
Jan 06, 2027
in 7 mo
Patent 7495103 expires
Listed drug substance patent expiration.
May 20, 2027
in 11 mo
Patent 8410274*PED expires
Listed listed patent expiration.
Jun 28, 2027
in 1 yr
Patent 8754224*PED expires
Listed listed patent expiration.
Jun 28, 2027
in 1 yr
Patent 9670163*PED expires
Listed listed patent expiration.
Jun 28, 2027
in 1 yr
Patent 8324242 expires
Listed method-of-use patent (U-1311) expiration.
Aug 05, 2027
in 1 yr 2 mo
Patent 8324242 expires
Listed method-of-use patent (U-1906) expiration.
Aug 05, 2027
in 1 yr 2 mo
Patent 7495103*PED expires
Listed listed patent expiration.
Nov 20, 2027
in 1 yr 5 mo
Exclusivity ends · ODE-338
Orphan-drug exclusivity (7 years)
Dec 21, 2027
in 1 yr 6 mo
Patent 8324242*PED expires
Listed listed patent expiration.
Feb 05, 2028
in 1 yr 8 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Jun 21, 2028
in 2 yr
Patent 10646481 expires
Listed drug product patent expiration.
Aug 13, 2029
in 3 yr 2 mo
Patent 11564916 expires
Listed method-of-use patent (U-3530) expiration.
Aug 13, 2029
in 3 yr 2 mo
Patent 12458635 expires
Listed drug product patent expiration.
Aug 13, 2029
in 3 yr 2 mo
Patent 10646481*PED expires
Listed listed patent expiration.
Feb 13, 2030
in 3 yr 9 mo
Patent 11564916*PED expires
Listed listed patent expiration.
Feb 13, 2030
in 3 yr 9 mo
Patent 12458635*PED expires
Listed listed patent expiration.
Feb 13, 2030
in 3 yr 9 mo
Pharmaceutical detail
Active ingredient
IVACAFTOR
Strength
150MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 203188
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- ODE-338Orphan-drug exclusivity (7 years)
Dec 21, 2027
in 1 yr 6 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 21, 2028
in 2 yr
Listed patents (20)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8354427 | Jul 06, 2026 | in 17 d | U-1905 |
| 8354427 | Jul 06, 2026 | in 17 d | U-1311 |
| 8410274 | Dec 28, 2026 | in 6 mo | Product |
| 8754224 | Dec 28, 2026 | in 6 mo | SubstanceProduct |
| 9670163 | Dec 28, 2026 | in 6 mo | ProductU-1311 |
| 8354427*PED | Jan 06, 2027 | in 7 mo | |
| 7495103 | May 20, 2027 | in 11 mo | SubstanceProduct |
| 8410274*PED | Jun 28, 2027 | in 1 yr | |
| 8754224*PED | Jun 28, 2027 | in 1 yr | |
| 9670163*PED | Jun 28, 2027 | in 1 yr | |
| 8324242 | Aug 05, 2027 | in 1 yr 2 mo | U-1311 |
| 8324242 | Aug 05, 2027 | in 1 yr 2 mo | U-1906 |
| 7495103*PED | Nov 20, 2027 | in 1 yr 5 mo | |
| 8324242*PED | Feb 05, 2028 | in 1 yr 8 mo | |
| 10646481 | Aug 13, 2029 | in 3 yr 2 mo | Product |
| 11564916 | Aug 13, 2029 | in 3 yr 2 mo | U-3530 |
| 12458635 | Aug 13, 2029 | in 3 yr 2 mo | ProductU-4339 |
| 10646481*PED | Feb 13, 2030 | in 3 yr 9 mo | |
| 11564916*PED | Feb 13, 2030 | in 3 yr 9 mo | |
| 12458635*PED | Feb 13, 2030 | in 3 yr 9 mo |
