FDA Orange Book
Is there a generic for Alyftrek?
Alyftrek contains vanzacaftor, tezacaftor and deutivacaftor. 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 Alyftrek (vanzacaftor, tezacaftor and deutivacaftor). The Orange Book shows its last listed patent expires January 10, 2043 and its last listed exclusivity ends March 27, 2033.
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Alyftrek products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 125MG;50MG;EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | 50MG;20MG;EQ 4MG BASE | Marketed (Rx) | None | 0 | None |
NDA 218730, 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.
Alyftrek patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8354427 | July 6, 2026 | Method of use | U-4091 | 218730 |
| 9670163 | December 28, 2026 | Drug product | U-4080 | 218730 |
| 9931334 | December 28, 2026 | Drug product | U-4080 | 218730 |
| 9931334 | December 28, 2026 | Drug product | U-4469 | 218730 |
| 9670163 | December 28, 2026 | Drug product | U-4470 | 218730 |
| 8754224 | December 28, 2026 | Drug substance, Drug product | None | 218730 |
| 8410274 | December 28, 2026 | Drug product | None | 218730 |
| 10022352 | April 9, 2027 | Drug product | U-4081 | 218730 |
| 9974781 | April 9, 2027 | Drug product | U-4082 | 218730 |
| 10239867 | April 9, 2027 | Drug substance, Drug product | U-4090 | 218730 |
| 11639347 | April 9, 2027 | Drug substance, Drug product | U-4090 | 218730 |
| 11639347 | April 9, 2027 | Drug substance, Drug product | U-4464 | 218730 |
| 10239867 | April 9, 2027 | Drug substance, Drug product | U-4464 | 218730 |
| 9974781 | April 9, 2027 | Drug product | U-4463 | 218730 |
| 8598181 | May 1, 2027 | Method of use | U-4090 | 218730 |
| 8598181 | May 1, 2027 | Method of use | U-4463 | 218730 |
| 7645789 | May 1, 2027 | Drug substance, Drug product | None | 218730 |
| 8623905 | May 1, 2027 | Drug substance, Drug product | None | 218730 |
| 7495103 | May 20, 2027 | Drug substance, Drug product | None | 218730 |
| 7776905 | June 3, 2027 | Drug substance, Drug product | None | 218730 |
| 8324242 | August 5, 2027 | Method of use | U-4090 | 218730 |
| 8324242 | August 5, 2027 | Method of use | U-4464 | 218730 |
| 8415387 | November 12, 2027 | Method of use | U-4082 | 218730 |
| 8415387 | November 12, 2027 | Method of use | U-4463 | 218730 |
| 11564916 | August 13, 2029 | Method of use | U-4095 | 218730 |
| 11564916 | August 13, 2029 | Method of use | U-4466 | 218730 |
| 10646481 | August 13, 2029 | Drug product | None | 218730 |
| 10081621 | March 25, 2031 | Drug product | U-4087 | 218730 |
| 11578062 | March 25, 2031 | Drug product | U-4096 | 218730 |
| 11578062 | March 25, 2031 | Drug product | U-4465 | 218730 |
| 10081621 | March 25, 2031 | Drug product | U-4468 | 218730 |
| RE50453 | July 10, 2031 | Drug substance, Drug product | None | 218730 |
| 9181192 | May 17, 2032 | Drug substance, Drug product | U-4094 | 218730 |
| 9512079 | May 17, 2032 | Drug substance, Drug product | U-4098 | 218730 |
| 9512079 | May 17, 2032 | Drug substance, Drug product | U-4471 | 218730 |
| 9181192 | May 17, 2032 | Drug substance, Drug product | U-4472 | 218730 |
| 8865902 | May 17, 2032 | Drug substance, Drug product | None | 218730 |
| 10047053 | May 17, 2032 | Drug substance | None | 218730 |
| 9012496 | July 15, 2033 | Method of use | U-4097 | 218730 |
| 10058546 | July 15, 2033 | Method of use | U-4218 | 218730 |
| 11951212 | April 14, 2035 | Drug product | U-4089 | 218730 |
| 10206877 | April 14, 2035 | Drug product | U-4092 | 218730 |
| 10206877 | April 14, 2035 | Drug product | U-4467 | 218730 |
| 11951212 | April 14, 2035 | Drug product | U-4461 | 218730 |
| 11866450 | February 14, 2039 | Method of use | U-4082 | 218730 |
| 11866450 | February 14, 2039 | Method of use | U-4463 | 218730 |
| 11066417 | February 14, 2039 | Drug substance, Drug product | None | 218730 |
| 11873300 | August 13, 2040 | Drug substance, Drug product | U-4083 | 218730 |
| 11873300 | August 13, 2040 | Drug substance, Drug product | U-4462 | 218730 |
| 12186306 | January 10, 2043 | Method of use | U-4088 | 218730 |
| 12186306 | January 10, 2043 | Method of use | U-4460 | 218730 |
Alyftrek exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | December 20, 2029 | 218730 |
| ODE-526 | Orphan drug exclusivity | December 20, 2031 | 218730 |
| ODE-536 | Orphan drug exclusivity | March 27, 2033 | 218730 |
Alyftrek NDC codes
Questions
Is there a generic for Alyftrek?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Alyftrek (vanzacaftor, tezacaftor and deutivacaftor). The Orange Book shows its last listed patent expires January 10, 2043 and its last listed exclusivity ends March 27, 2033.
What is the generic name for Alyftrek?
The active ingredient in Alyftrek is vanzacaftor, tezacaftor and deutivacaftor, per the FDA Orange Book.
When does the Alyftrek patent expire?
The last patent listed for Alyftrek in the Orange Book expires January 10, 2043. 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.