FDA Orange Book
Is there a generic for Orkambi?
Orkambi contains lumacaftor 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 Orkambi (lumacaftor and ivacaftor). The Orange Book shows its last listed patent expires June 11, 2031 and its last listed exclusivity ends March 2, 2030.
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Orkambi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| granule, oral | 125MG/PACKET;100MG/PACKET | Marketed (Rx) | None | 0 | None |
| granule, oral | 188MG/PACKET;150MG/PACKET | Marketed (Rx) | None | 0 | None |
| granule, oral | 94MG/PACKET;75MG/PACKET | Marketed (Rx) | None | 0 | None |
| tablet, oral | 125MG;100MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 125MG;200MG | Marketed (Rx) | None | 0 | None |
NDA 211358, 206038, 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.
Orkambi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7973038 | November 8, 2026 | Method of use | U-3424 | 211358 |
| 8741933 | November 8, 2026 | Method of use | U-3424 | 211358 |
| 9216969 | November 8, 2026 | Drug product | None | 211358 |
| 7973038 | November 8, 2026 | Method of use | U-2374 | 211358 |
| 8741933 | November 8, 2026 | Method of use | U-2374 | 211358 |
| 7973038 | November 8, 2026 | Method of use | U-1973 | 206038 |
| 8741933 | November 8, 2026 | Method of use | U-1909 | 206038 |
| 8741933 | November 8, 2026 | Method of use | U-1717 | 206038 |
| 9670163 | December 28, 2026 | Drug product | U-3429 | 211358 |
| 9931334 | December 28, 2026 | Drug product | U-3429 | 211358 |
| 8410274 | December 28, 2026 | Drug product | None | 211358 |
| 8754224 | December 28, 2026 | Drug substance, Drug product | None | 211358 |
| 9931334 | December 28, 2026 | Drug product | U-2376 | 211358 |
| 9670163 | December 28, 2026 | Drug product | U-2376 | 211358 |
| 9931334 | December 28, 2026 | Drug product | U-2276 | 206038 |
| 9670163 | December 28, 2026 | Drug product | U-1911 | 206038 |
| 9216969*PED | May 8, 2027 | Method of use | None | 211358 |
| 7973038*PED | May 8, 2027 | Method of use | None | 211358 |
| 8741933*PED | May 8, 2027 | Method of use | None | 211358 |
| 7495103 | May 20, 2027 | Drug substance, Drug product | None | 211358 |
| 9670163*PED | June 28, 2027 | Method of use | None | 211358 |
| 9931334*PED | June 28, 2027 | Method of use | None | 211358 |
| 8410274*PED | June 28, 2027 | Method of use | None | 211358 |
| 8754224*PED | June 28, 2027 | Method of use | None | 211358 |
| 8324242 | August 5, 2027 | Method of use | U-3424 | 211358 |
| 8324242 | August 5, 2027 | Method of use | U-2374 | 211358 |
| 8324242 | August 5, 2027 | Method of use | U-1911 | 206038 |
| 8324242 | August 5, 2027 | Method of use | U-1311 | 206038 |
| 7495103*PED | November 20, 2027 | Method of use | None | 211358 |
| 8324242*PED | February 5, 2028 | Method of use | None | 211358 |
| 9150552 | December 4, 2028 | Method of use | U-3427 | 211358 |
| 12065432 | December 4, 2028 | Method of use | U-3983 | 211358 |
| 10597384 | December 4, 2028 | Drug substance, Drug product | U-3430 | 211358 |
| 8653103 | December 4, 2028 | Drug product | None | 211358 |
| 9150552 | December 4, 2028 | Method of use | U-2375 | 211358 |
| 10597384 | December 4, 2028 | Drug substance, Drug product | U-2778 | 211358 |
| 9150552 | December 4, 2028 | Method of use | U-1908 | 206038 |
| 10597384 | December 4, 2028 | Drug substance, Drug product | U-2777 | 206038 |
| 12065432 | December 4, 2028 | Method of use | U-3984 | 206038 |
| 11052075 | December 4, 2028 | Drug product | U-3181 | 206038 |
| 10076513 | December 4, 2028 | Drug product | U-2411 | 206038 |
| 10597384*PED | June 4, 2029 | Method of use | None | 211358 |
| 12065432*PED | June 4, 2029 | Method of use | None | 211358 |
| 8653103*PED | June 4, 2029 | Method of use | None | 211358 |
| 9150552*PED | June 4, 2029 | Method of use | None | 211358 |
| 11052075*PED | June 4, 2029 | Method of use | None | 206038 |
| 10076513*PED | June 4, 2029 | Method of use | None | 206038 |
| 8846718 | July 2, 2029 | Method of use | U-3427 | 211358 |
| 8846718 | July 2, 2029 | Method of use | U-2375 | 211358 |
| 8846718 | July 2, 2029 | Method of use | U-1908 | 206038 |
| 8846718 | July 2, 2029 | Method of use | U-1717 | 206038 |
| 12458635 | August 13, 2029 | Drug product | U-4335 | 211358 |
| 11564916 | August 13, 2029 | Method of use | U-3526 | 211358 |
| 10646481 | August 13, 2029 | Drug product | None | 211358 |
| 12458635 | August 13, 2029 | Drug product | U-4338 | 206038 |
| 11564916 | August 13, 2029 | Method of use | U-3529 | 206038 |
| 9192606 | September 29, 2029 | Drug product | U-3428 | 211358 |
| 9192606 | September 29, 2029 | Drug product | U-2397 | 211358 |
| 9192606 | September 29, 2029 | Drug product | U-1912 | 206038 |
| 8846718*PED | January 2, 2030 | Method of use | None | 211358 |
Showing 60 of 73 listed patents.
Orkambi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-14 | Miscellaneous | December 13, 2027 | 211358 |
| PED | Pediatric exclusivity | June 13, 2028 | 211358 |
| ODE-408 | Orphan drug exclusivity | September 2, 2029 | 211358 |
| PED | Pediatric exclusivity | March 2, 2030 | 211358 |
Orkambi NDC codes
Questions
Is there a generic for Orkambi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Orkambi (lumacaftor and ivacaftor). The Orange Book shows its last listed patent expires June 11, 2031 and its last listed exclusivity ends March 2, 2030.
What is the generic name for Orkambi?
The active ingredient in Orkambi is lumacaftor and ivacaftor, per the FDA Orange Book.
When does the Orkambi patent expire?
The last patent listed for Orkambi in the Orange Book expires June 11, 2031. 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.