IVACAFTOR; LUMACAFTOR
| Brand name | ORKAMBI |
|---|---|
| Active ingredient | IVACAFTOR; LUMACAFTOR |
| Strength | 125MG;100MG |
| Dosage form | TABLET |
| Route | ORAL |
| Modality | Small molecule |
| FDA approval | September 2016 |
| Marketing status | RX |
| Patent | Expires | Type |
|---|---|---|
| 8993600*PED | June 2031 | — |
| 8507534*PED | March 2031 | — |
| 8716338*PED | March 2031 | — |
| 8993600 | December 2030 | product |
| 8716338 | September 2030 | product |
| 8507534 | September 2030 | substance, product |
| 9192606*PED | March 2030 | — |
| 12458635*PED | February 2030 | — |
| 11564916*PED | February 2030 | — |
| 10646481*PED | February 2030 | — |
| 8846718*PED | January 2030 | — |
| 9192606 | September 2029 | product |
| 12458635 | August 2029 | product |
| 10646481 | August 2029 | product |
| 11564916 | August 2029 | use U-3529 |
| 8846718 | July 2029 | use U-1908 |
| 12065432*PED | June 2029 | — |
| 10597384*PED | June 2029 | — |
| 8653103*PED | June 2029 | — |
| 11052075*PED | June 2029 | — |
| 9150552*PED | June 2029 | — |
| 10597384 | December 2028 | substance, product |
| 11052075 | December 2028 | product |
| 12065432 | December 2028 | use U-3984 |
| 8653103 | December 2028 | product |
| 9150552 | December 2028 | use U-1908 |
| 8324242*PED | February 2028 | — |
| 7495103*PED | November 2027 | — |
| 8324242 | August 2027 | use U-1911 |
| 9670163*PED | June 2027 | — |
| 8754224*PED | June 2027 | — |
| 8410274*PED | June 2027 | — |
| 9931334*PED | June 2027 | — |
| 7495103 | May 2027 | substance, product |
| 7973038*PED | May 2027 | — |
| 9216969*PED | May 2027 | — |
| 8741933*PED | May 2027 | — |
| 8410274 | December 2026 | product |
| 8754224 | December 2026 | substance, product |
| 9670163 | December 2026 | product |
| 9931334 | December 2026 | product |
| 7973038 | November 2026 | use U-1973 |
| 9216969 | November 2026 | product |
| 8741933 | November 2026 | use U-1909 |
Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.