FDA Orange Book
Is there a generic for Symdeko (copackaged)?
Symdeko (copackaged) contains ivacaftor and ivacaftor tezacaftor. 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 Symdeko (copackaged) (ivacaftor and ivacaftor tezacaftor). The Orange Book shows its last listed patent expires April 14, 2035 and its last listed exclusivity ends December 21, 2027.
Run it in Rivvi
Map Symdeko (copackaged) and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Symdeko (copackaged) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG;150MG, 100MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 75MG;75MG, 50MG | Marketed (Rx) | None | 0 | None |
NDA 210491, 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.
Symdeko (copackaged) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8354427 | July 6, 2026 | Method of use | U-3021 | 210491 |
| 9670163 | December 28, 2026 | Drug product | U-2246 | 210491 |
| 9931334 | December 28, 2026 | Drug product | U-2575 | 210491 |
| 9931334 | December 28, 2026 | Drug product | U-2275 | 210491 |
| 8410274 | December 28, 2026 | Drug product | None | 210491 |
| 8754224 | December 28, 2026 | Drug substance, Drug product | None | 210491 |
| 10239867 | April 9, 2027 | Drug substance, Drug product | U-2512 | 210491 |
| 10022352 | April 9, 2027 | Drug product | U-2343 | 210491 |
| 11639347 | April 9, 2027 | Drug substance, Drug product | U-2569 | 210491 |
| 10239867 | April 9, 2027 | Drug substance, Drug product | U-2569 | 210491 |
| 9974781 | April 9, 2027 | Drug product | U-2574 | 210491 |
| 10022352 | April 9, 2027 | Drug product | U-2573 | 210491 |
| 9974781 | April 9, 2027 | Drug product | U-2318 | 210491 |
| 8598181 | May 1, 2027 | Method of use | U-2246 | 210491 |
| 7645789 | May 1, 2027 | Drug substance, Drug product | None | 210491 |
| 8623905 | May 1, 2027 | Drug substance, Drug product | None | 210491 |
| 7495103 | May 20, 2027 | Drug substance, Drug product | None | 210491 |
| 7776905 | June 3, 2027 | Drug substance, Drug product | None | 210491 |
| 8324242 | August 5, 2027 | Method of use | U-2246 | 210491 |
| 8415387 | November 12, 2027 | Method of use | U-2246 | 210491 |
| 12458635 | August 13, 2029 | Drug product | U-4336 | 210491 |
| 11564916 | August 13, 2029 | Method of use | U-3527 | 210491 |
| 10646481 | August 13, 2029 | Drug product | None | 210491 |
| 11578062 | March 25, 2031 | Drug product | U-3545 | 210491 |
| 10081621 | March 25, 2031 | Drug product | U-3024 | 210491 |
| 10081621 | March 25, 2031 | Drug product | U-3025 | 210491 |
| RE50453 | July 10, 2031 | Drug substance, Drug product | None | 210491 |
| 10058546 | July 15, 2033 | Method of use | U-3022 | 210491 |
| 10058546 | July 15, 2033 | Method of use | U-3023 | 210491 |
| 9012496 | July 15, 2033 | Method of use | U-2248 | 210491 |
| 10206877 | April 14, 2035 | Drug product | U-3026 | 210491 |
| 10206877 | April 14, 2035 | Drug product | U-3027 | 210491 |
| 11951212 | April 14, 2035 | Drug product | U-3894 | 210491 |
Symdeko (copackaged) exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-247 | Orphan drug exclusivity | June 21, 2026 | 210491 |
| ODE-335 | Orphan drug exclusivity | December 21, 2027 | 210491 |
Questions
Is there a generic for Symdeko (copackaged)?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Symdeko (copackaged) (ivacaftor and ivacaftor tezacaftor). The Orange Book shows its last listed patent expires April 14, 2035 and its last listed exclusivity ends December 21, 2027.
What is the generic name for Symdeko (copackaged)?
The active ingredient in Symdeko (copackaged) is ivacaftor and ivacaftor tezacaftor, per the FDA Orange Book.
When does the Symdeko (copackaged) patent expire?
The last patent listed for Symdeko (copackaged) in the Orange Book expires April 14, 2035. 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.