FDA Orange Book
Is there a generic for Trikafta (copackaged)?
Trikafta (copackaged) contains elexacaftor ivacaftor tezacaftor and ivacaftor. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Trikafta (copackaged) (elexacaftor ivacaftor tezacaftor and ivacaftor). The Orange Book shows its last listed patent expires July 17, 2038 and its last listed exclusivity ends March 27, 2033.
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Trikafta (copackaged) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| granule, oral | 100MG, 75MG, 50MG;75MG | Marketed (Rx) | None | 0 | None |
| granule, oral | 80MG, 60MG, 40MG;59.5MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 100MG,75MG,50MG; 150MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 50MG,37.5MG,25MG; 75MG | Marketed (Rx) | None | 0 | None |
NDA 217660, 212273, held by VERTEX PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Trikafta (copackaged) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8354427 | July 6, 2026 | Method of use | U-3593 | 217660 |
| 8354427 | July 6, 2026 | Method of use | U-3145 | 212273 |
| 8354427 | July 6, 2026 | Method of use | U-3029 | 212273 |
| 9931334 | December 28, 2026 | Drug product | U-4068 | 217660 |
| 9670163 | December 28, 2026 | Drug product | U-4068 | 217660 |
| 9670163 | December 28, 2026 | Drug product | U-3591 | 217660 |
| 9931334 | December 28, 2026 | Drug product | U-3591 | 217660 |
| 9670163 | December 28, 2026 | Drug product | U-4478 | 217660 |
| 9931334 | December 28, 2026 | Drug product | U-4478 | 217660 |
| 8410274 | December 28, 2026 | Drug product | None | 217660 |
| 8754224 | December 28, 2026 | Drug substance, Drug product | None | 217660 |
| 9931334 | December 28, 2026 | Drug product | U-4078 | 212273 |
| 9670163 | December 28, 2026 | Drug product | U-4078 | 212273 |
| 9670163 | December 28, 2026 | Drug product | U-3155 | 212273 |
| 9931334 | December 28, 2026 | Drug product | U-3155 | 212273 |
| 9670163 | December 28, 2026 | Drug product | U-4477 | 212273 |
| 9931334 | December 28, 2026 | Drug product | U-4479 | 212273 |
| 9670163 | December 28, 2026 | Drug product | U-3031 | 212273 |
| 9931334 | December 28, 2026 | Drug product | U-3031 | 212273 |
| 9974781 | April 9, 2027 | Drug product | U-4066 | 217660 |
| 11639347 | April 9, 2027 | Drug substance, Drug product | U-3583 | 217660 |
| 10239867 | April 9, 2027 | Drug substance, Drug product | U-3590 | 217660 |
| 9974781 | April 9, 2027 | Drug product | U-3589 | 217660 |
| 10239867 | April 9, 2027 | Drug substance, Drug product | U-4053 | 217660 |
| 10022352 | April 9, 2027 | Drug product | U-3596 | 217660 |
| 11639347 | April 9, 2027 | Drug substance, Drug product | U-4053 | 217660 |
| 9974781 | April 9, 2027 | Drug product | U-4476 | 217660 |
| 10239867 | April 9, 2027 | Drug substance, Drug product | U-4476 | 217660 |
| 11639347 | April 9, 2027 | Drug substance, Drug product | U-4476 | 217660 |
| 11639347 | April 9, 2027 | Drug substance, Drug product | U-3587 | 212273 |
| 9974781 | April 9, 2027 | Drug product | U-3144 | 212273 |
| 10022352 | April 9, 2027 | Drug product | U-3156 | 212273 |
| 10239867 | April 9, 2027 | Drug substance, Drug product | U-3158 | 212273 |
| 10239867 | April 9, 2027 | Drug substance, Drug product | U-4056 | 212273 |
| 9974781 | April 9, 2027 | Drug product | U-4073 | 212273 |
| 11639347 | April 9, 2027 | Drug substance, Drug product | U-4056 | 212273 |
| 9974781 | April 9, 2027 | Drug product | U-4475 | 212273 |
| 10239867 | April 9, 2027 | Drug substance, Drug product | U-4475 | 212273 |
| 11639347 | April 9, 2027 | Drug substance, Drug product | U-4475 | 212273 |
| 10022352 | April 9, 2027 | Drug product | U-2651 | 212273 |
| 9974781 | April 9, 2027 | Drug product | U-3028 | 212273 |
| 10239867 | April 9, 2027 | Drug substance, Drug product | U-3033 | 212273 |
| 8598181 | May 1, 2027 | Method of use | U-4066 | 217660 |
| 8598181 | May 1, 2027 | Method of use | U-3589 | 217660 |
| 8598181 | May 1, 2027 | Method of use | U-4476 | 217660 |
| 8623905 | May 1, 2027 | Drug substance, Drug product | None | 217660 |
| 7645789 | May 1, 2027 | Drug substance, Drug product | None | 217660 |
| 8598181 | May 1, 2027 | Method of use | U-3144 | 212273 |
| 8598181 | May 1, 2027 | Method of use | U-4056 | 212273 |
| 8598181 | May 1, 2027 | Method of use | U-4475 | 212273 |
| 8598181 | May 1, 2027 | Method of use | U-3028 | 212273 |
| 7495103 | May 20, 2027 | Drug substance, Drug product | None | 217660 |
| 7776905 | June 3, 2027 | Drug substance, Drug product | None | 217660 |
| 8324242 | August 5, 2027 | Method of use | U-4066 | 217660 |
| 8324242 | August 5, 2027 | Method of use | U-3589 | 217660 |
| 8324242 | August 5, 2027 | Method of use | U-4476 | 217660 |
| 8324242 | August 5, 2027 | Method of use | U-4073 | 212273 |
| 8324242 | August 5, 2027 | Method of use | U-3144 | 212273 |
| 8324242 | August 5, 2027 | Method of use | U-4475 | 212273 |
| 8324242 | August 5, 2027 | Method of use | U-3028 | 212273 |
Showing 60 of 144 listed patents.
Trikafta (copackaged) exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | April 26, 2026 | 217660 |
| ODE* | See the Orange Book exclusivity code list | October 21, 2026 | 212273 |
| ODE-275 | Orphan drug exclusivity | October 21, 2026 | 212273 |
| M-313 | Miscellaneous | December 20, 2027 | 217660 |
| ODE* | See the Orange Book exclusivity code list | December 21, 2027 | 212273 |
| ODE-323 | Orphan drug exclusivity | December 21, 2027 | 212273 |
| ODE-357 | Orphan drug exclusivity | June 8, 2028 | 212273 |
| ODE-433 | Orphan drug exclusivity | April 26, 2030 | 217660 |
| ODE-512 | Orphan drug exclusivity | December 20, 2031 | 217660 |
| ODE-543 | Orphan drug exclusivity | March 27, 2033 | 217660 |
Questions
Is there a generic for Trikafta (copackaged)?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Trikafta (copackaged) (elexacaftor ivacaftor tezacaftor and ivacaftor). The Orange Book shows its last listed patent expires July 17, 2038 and its last listed exclusivity ends March 27, 2033.
What is the generic name for Trikafta (copackaged)?
The active ingredient in Trikafta (copackaged) is elexacaftor ivacaftor tezacaftor and ivacaftor, per the FDA Orange Book.
When does the Trikafta (copackaged) patent expire?
The last patent listed for Trikafta (copackaged) in the Orange Book expires July 17, 2038. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.