FDA Orange Book
Is there a generic for Kalydeco?
Kalydeco contains 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 Kalydeco (ivacaftor). The Orange Book shows its last listed patent expires August 27, 2033 and its last listed exclusivity ends November 3, 2030.
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Kalydeco products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| granule, oral | 13.4MG/PACKET | Marketed (Rx) | None | 0 | None |
| granule, oral | 25MG/PACKET | Marketed (Rx) | None | 0 | None |
| granule, oral | 5.8MG/PACKET | Marketed (Rx) | None | 0 | None |
| granule, oral | 50MG/PACKET | Marketed (Rx) | None | 0 | None |
| granule, oral | 75MG/PACKET | Marketed (Rx) | None | 0 | None |
| tablet, oral | 150MG | Marketed (Rx) | None | 0 | None |
NDA 207925, 203188, 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.
Kalydeco patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8354427 | July 6, 2026 | Method of use | U-3608 | 207925 |
| 8354427 | July 6, 2026 | Method of use | U-1311 | 207925 |
| 8354427 | July 6, 2026 | Method of use | U-1905 | 207925 |
| 8354427 | July 6, 2026 | Method of use | U-2964 | 207925 |
| 8354427 | July 6, 2026 | Method of use | U-2528 | 207925 |
| 9670163 | December 28, 2026 | Drug product | U-3606 | 207925 |
| 8754224 | December 28, 2026 | Drug substance, Drug product | None | 207925 |
| 8410274 | December 28, 2026 | Drug product | None | 207925 |
| 9670163 | December 28, 2026 | Drug product | U-1311 | 207925 |
| 9670163 | December 28, 2026 | Drug product | U-2966 | 207925 |
| 9670163 | December 28, 2026 | Drug product | U-2530 | 207925 |
| 8354427*PED | January 6, 2027 | Method of use | None | 207925 |
| 7495103 | May 20, 2027 | Drug substance, Drug product | None | 207925 |
| 9670163*PED | June 28, 2027 | Method of use | None | 207925 |
| 8754224*PED | June 28, 2027 | Method of use | None | 207925 |
| 8410274*PED | June 28, 2027 | Method of use | None | 207925 |
| 8324242 | August 5, 2027 | Method of use | U-3609 | 207925 |
| 8324242 | August 5, 2027 | Method of use | U-1311 | 207925 |
| 8324242 | August 5, 2027 | Method of use | U-1906 | 207925 |
| 8324242 | August 5, 2027 | Method of use | U-2963 | 207925 |
| 8324242 | August 5, 2027 | Method of use | U-2527 | 207925 |
| 7495103*PED | November 20, 2027 | Method of use | None | 207925 |
| 8324242*PED | February 5, 2028 | Method of use | None | 207925 |
| 11564916 | August 13, 2029 | Method of use | U-3603 | 207925 |
| 12458635 | August 13, 2029 | Drug product | U-4337 | 207925 |
| 10646481 | August 13, 2029 | Drug product | None | 207925 |
| 11564916 | August 13, 2029 | Method of use | U-3528 | 207925 |
| 12458635 | August 13, 2029 | Drug product | U-4339 | 203188 |
| 11564916 | August 13, 2029 | Method of use | U-3530 | 203188 |
| 11564916*PED | February 13, 2030 | Method of use | None | 207925 |
| 10646481*PED | February 13, 2030 | Method of use | None | 207925 |
| 12458635*PED | February 13, 2030 | Method of use | None | 207925 |
| 11147770 | February 27, 2033 | Drug product | U-3604 | 207925 |
| 10272046 | February 27, 2033 | Drug product | U-3605 | 207925 |
| 12214083 | February 27, 2033 | Drug product | U-4127 | 207925 |
| 11752106 | February 27, 2033 | Drug product | U-3697 | 207925 |
| 8883206 | February 27, 2033 | Drug product | None | 207925 |
| 12214083 | February 27, 2033 | Drug product | U-4128 | 207925 |
| 10272046 | February 27, 2033 | Drug product | U-2967 | 207925 |
| 11147770 | February 27, 2033 | Drug product | U-3339 | 207925 |
| 12214083 | February 27, 2033 | Drug product | U-4126 | 207925 |
| 10272046 | February 27, 2033 | Drug product | U-2531 | 207925 |
| 11752106*PED | August 27, 2033 | Method of use | None | 207925 |
| 12214083*PED | August 27, 2033 | Method of use | None | 207925 |
| 11147770*PED | August 27, 2033 | Method of use | None | 207925 |
| 10272046*PED | August 27, 2033 | Method of use | None | 207925 |
| 8883206*PED | August 27, 2033 | Method of use | None | 207925 |
Kalydeco exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-236 | Orphan drug exclusivity | April 29, 2026 | 207925 |
| NPP | New patient population | May 3, 2026 | 207925 |
| PED | Pediatric exclusivity | October 29, 2026 | 207925 |
| PED | Pediatric exclusivity | November 3, 2026 | 207925 |
| ODE-338 | Orphan drug exclusivity | December 21, 2027 | 207925 |
| M-14 | Miscellaneous | May 22, 2028 | 207925 |
| PED | Pediatric exclusivity | June 21, 2028 | 207925 |
| PED | Pediatric exclusivity | November 22, 2028 | 207925 |
| ODE-435 | Orphan drug exclusivity | May 3, 2030 | 207925 |
| PED | Pediatric exclusivity | November 3, 2030 | 207925 |
Kalydeco NDC codes
Questions
Is there a generic for Kalydeco?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Kalydeco (ivacaftor). The Orange Book shows its last listed patent expires August 27, 2033 and its last listed exclusivity ends November 3, 2030.
What is the generic name for Kalydeco?
The active ingredient in Kalydeco is ivacaftor, per the FDA Orange Book.
When does the Kalydeco patent expire?
The last patent listed for Kalydeco in the Orange Book expires August 27, 2033. 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.