Orange Book product · Brand (NDA)
ALYFTREK
DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
At a glance
Dec 20, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
43
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 20, 2024
1 yr 6 mo ago
Today
Patent 8354427 expires
Listed method-of-use patent (U-4091) 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 9670163 expires
Listed drug product patent expiration.
Dec 28, 2026
in 6 mo
Patent 9931334 expires
Listed drug product patent expiration.
Dec 28, 2026
in 6 mo
Patent 9931334 expires
Listed drug product patent expiration.
Dec 28, 2026
in 6 mo
Patent 10022352 expires
Listed drug product patent expiration.
Apr 09, 2027
in 10 mo
Patent 10239867 expires
Listed drug substance patent expiration.
Apr 09, 2027
in 10 mo
Patent 10239867 expires
Listed drug substance patent expiration.
Apr 09, 2027
in 10 mo
Patent 11639347 expires
Listed drug substance patent expiration.
Apr 09, 2027
in 10 mo
Patent 11639347 expires
Listed drug substance patent expiration.
Apr 09, 2027
in 10 mo
Patent 9974781 expires
Listed drug product patent expiration.
Apr 09, 2027
in 10 mo
Patent 9974781 expires
Listed drug product patent expiration.
Apr 09, 2027
in 10 mo
Patent 7645789 expires
Listed drug substance patent expiration.
May 01, 2027
in 11 mo
Patent 8598181 expires
Listed method-of-use patent (U-4090) expiration.
May 01, 2027
in 11 mo
Patent 8598181 expires
Listed method-of-use patent (U-4463) expiration.
May 01, 2027
in 11 mo
Patent 8623905 expires
Listed drug substance patent expiration.
May 01, 2027
in 11 mo
Patent 7495103 expires
Listed drug substance patent expiration.
May 20, 2027
in 11 mo
Patent 7776905 expires
Listed drug substance patent expiration.
Jun 03, 2027
in 1 yr
Patent 8324242 expires
Listed method-of-use patent (U-4090) expiration.
Aug 05, 2027
in 1 yr 2 mo
Patent 8324242 expires
Listed method-of-use patent (U-4464) expiration.
Aug 05, 2027
in 1 yr 2 mo
Patent 8415387 expires
Listed method-of-use patent (U-4082) expiration.
Nov 12, 2027
in 1 yr 5 mo
Patent 8415387 expires
Listed method-of-use patent (U-4463) expiration.
Nov 12, 2027
in 1 yr 5 mo
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-4095) expiration.
Aug 13, 2029
in 3 yr 2 mo
Patent 11564916 expires
Listed method-of-use patent (U-4466) expiration.
Aug 13, 2029
in 3 yr 2 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Dec 20, 2029
in 3 yr 7 mo
Patent 10081621 expires
Listed drug product patent expiration.
Mar 25, 2031
in 4 yr 10 mo
Patent 10081621 expires
Listed drug product patent expiration.
Mar 25, 2031
in 4 yr 10 mo
Patent 11578062 expires
Listed drug product patent expiration.
Mar 25, 2031
in 4 yr 10 mo
Patent 11578062 expires
Listed drug product patent expiration.
Mar 25, 2031
in 4 yr 10 mo
Patent RE50453 expires
Listed drug substance patent expiration.
Jul 10, 2031
in 5 yr 2 mo
Exclusivity ends · ODE-526
Orphan-drug exclusivity (7 years)
Dec 20, 2031
in 5 yr 7 mo
Patent 10047053 expires
Listed drug substance patent expiration.
May 17, 2032
in 6 yr
Patent 8865902 expires
Listed drug substance patent expiration.
May 17, 2032
in 6 yr
Patent 9181192 expires
Listed drug substance patent expiration.
May 17, 2032
in 6 yr
Patent 9181192 expires
Listed drug substance patent expiration.
May 17, 2032
in 6 yr
Patent 9512079 expires
Listed drug substance patent expiration.
May 17, 2032
in 6 yr
Patent 9512079 expires
Listed drug substance patent expiration.
May 17, 2032
in 6 yr
Exclusivity ends · ODE-536
Orphan-drug exclusivity (7 years)
Mar 27, 2033
in 6 yr 10 mo
Patent 11066417 expires
Listed drug substance patent expiration.
Feb 14, 2039
in 12 yr 10 mo
Patent 11866450 expires
Listed method-of-use patent (U-4082) expiration.
Feb 14, 2039
in 12 yr 10 mo
Patent 11866450 expires
Listed method-of-use patent (U-4463) expiration.
Feb 14, 2039
in 12 yr 10 mo
Patent 11873300 expires
Listed drug substance patent expiration.
Aug 13, 2040
in 14 yr 4 mo
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 familyThis 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)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8354427 | Jul 06, 2026 | in 17 d | U-4091 |
| 8410274 | Dec 28, 2026 | in 6 mo | Product |
| 8754224 | Dec 28, 2026 | in 6 mo | SubstanceProduct |
| 9670163 | Dec 28, 2026 | in 6 mo | ProductU-4080 |
| 9670163 | Dec 28, 2026 | in 6 mo | ProductU-4470 |
| 9931334 | Dec 28, 2026 | in 6 mo | ProductU-4080 |
| 9931334 | Dec 28, 2026 | in 6 mo | ProductU-4469 |
| 10022352 | Apr 09, 2027 | in 10 mo | ProductU-4081 |
| 10239867 | Apr 09, 2027 | in 10 mo | SubstanceProductU-4090 |
| 10239867 | Apr 09, 2027 | in 10 mo | SubstanceProductU-4464 |
| 11639347 | Apr 09, 2027 | in 10 mo | SubstanceProductU-4090 |
| 11639347 | Apr 09, 2027 | in 10 mo | SubstanceProductU-4464 |
| 9974781 | Apr 09, 2027 | in 10 mo | ProductU-4082 |
| 9974781 | Apr 09, 2027 | in 10 mo | ProductU-4463 |
| 7645789 | May 01, 2027 | in 11 mo | SubstanceProduct |
| 8598181 | May 01, 2027 | in 11 mo | U-4090 |
| 8598181 | May 01, 2027 | in 11 mo | U-4463 |
| 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-4090 |
| 8324242 | Aug 05, 2027 | in 1 yr 2 mo | U-4464 |
| 8415387 | Nov 12, 2027 | in 1 yr 5 mo | U-4082 |
| 8415387 | Nov 12, 2027 | in 1 yr 5 mo | U-4463 |
| 10646481 | Aug 13, 2029 | in 3 yr 2 mo | Product |
| 11564916 | Aug 13, 2029 | in 3 yr 2 mo | U-4095 |
| 11564916 | Aug 13, 2029 | in 3 yr 2 mo | U-4466 |
| 10081621 | Mar 25, 2031 | in 4 yr 10 mo | ProductU-4087 |
| 10081621 | Mar 25, 2031 | in 4 yr 10 mo | ProductU-4468 |
| 11578062 | Mar 25, 2031 | in 4 yr 10 mo | ProductU-4096 |
| 11578062 | Mar 25, 2031 | in 4 yr 10 mo | ProductU-4465 |
| RE50453 | Jul 10, 2031 | in 5 yr 2 mo | SubstanceProduct |
| 10047053 | May 17, 2032 | in 6 yr | Substance |
| 8865902 | May 17, 2032 | in 6 yr | SubstanceProduct |
| 9181192 | May 17, 2032 | in 6 yr | SubstanceProductU-4094 |
| 9181192 | May 17, 2032 | in 6 yr | SubstanceProductU-4472 |
| 9512079 | May 17, 2032 | in 6 yr | SubstanceProductU-4098 |
| 9512079 | May 17, 2032 | in 6 yr | SubstanceProductU-4471 |
| 11066417 | Feb 14, 2039 | in 12 yr 10 mo | SubstanceProduct |
| 11866450 | Feb 14, 2039 | in 12 yr 10 mo | U-4082 |
| 11866450 | Feb 14, 2039 | in 12 yr 10 mo | U-4463 |
| 11873300 | Aug 13, 2040 | in 14 yr 4 mo | SubstanceProductU-4083 |
| 11873300 | Aug 13, 2040 | in 14 yr 4 mo | SubstanceProductU-4462 |

