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  1. pharmadog
  2. ›drugs
  3. ›Orkambi
drug
save

(ivacaftor + lumacaftor)

Marketedupdated 3mo ago
by $VERX Vertex, Inc.
Approved
community read0 votes

🐶 often sniffed alongside

top 6
  • drugORKAMBI40 co-mentions · 20 sources
  • tagApproval40 co-mentions · 20 sources
  • drugKALYDECO20 co-mentions · 20 sources
  • drugSYMDEKO (COPACKAGED)20 co-mentions · 20 sources
  • drugivacaftor20 co-mentions · 20 sources
  • tagSmall Molecule20 co-mentions · 20 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 8 investigational indications.

indications

investigational
Cystic Fibrosis

all catalysts(20)

approval · 20
Jul 2, 2015
approval
$VERX12.39-7.54%
11y ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Mar 18, 2016
approval
$VERX12.39-7.54%
10y ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Apr 6, 2016
approval
$VERX12.39-7.54%
10y ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
May 18, 2016
approval
$VERX12.39-7.54%
10y ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Aug 5, 2016
approval
$VERX12.39-7.54%
10y ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 6, 2016
approval
$VERX12.39-7.54%
10y ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 28, 2016
approval
$VERX12.39-7.54%
10y ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Jan 25, 2018
approval
$VERX12.39-7.54%
9y ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Aug 7, 2018
approval
$VERX12.39-7.54%
8y ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Aug 15, 2018
approval
$VERX12.39-7.54%
8y ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 2, 2022
approval
$VERX12.39-7.54%
4y ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 2, 2022
approval
$VERX12.39-7.54%
4y ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Aug 3, 2023
approval
$VERX12.39-7.54%
3y ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Aug 3, 2023
approval
$VERX12.39-7.54%
3y ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Dec 13, 2024
approval
$VERX12.39-7.54%
2y ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Dec 13, 2024
approval
$VERX12.39-7.54%
2y ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 25, 2025
approval
$VERX12.39-7.54%
10mo ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 25, 2025
approval
$VERX12.39-7.54%
10mo ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Mar 17, 2026
approval
$VERX12.39-7.54%
5mo ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Mar 17, 2026
approval
$VERX12.39-7.54%
5mo ago
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
view all 20 catalysts →

Patent cliff

source: FDA Orange Book
first barrier falls
Nov 8, 2026
95 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (216)

  • Jun 11, 2031patentUS 8993600*PED4.9y
  • Jun 11, 2031patentUS 8993600*PED4.9y
  • Jun 11, 2031patentUS 8993600*PED4.9y
  • Jun 11, 2031patentUS 8993600*PED4.9y
  • Jun 11, 2031patentUS 8993600*PED4.9y
  • Mar 20, 2031patentUS 8507534*PED4.6y
  • Mar 20, 2031patentUS 8507534*PED4.6y
  • Mar 20, 2031patentUS 8507534*PED4.6y
  • Mar 20, 2031patentUS 8507534*PED4.6y
  • Mar 20, 2031patentUS 8507534*PED4.6y
  • Mar 20, 2031patentUS 8716338*PED4.6y
  • Mar 20, 2031patentUS 8716338*PED4.6y
  • Mar 20, 2031patentUS 8716338*PED4.6y
  • Mar 20, 2031patentUS 8716338*PED4.6y
  • Mar 20, 2031patentUS 8716338*PED4.6y
  • Dec 11, 2030formulationUS 89936004.4y
  • Dec 11, 2030formulationUS 89936004.4y
  • Dec 11, 2030formulationUS 89936004.4y
  • Dec 11, 2030formulationUS 89936004.4y
  • Dec 11, 2030formulationUS 89936004.4y
  • Sep 20, 2030compositionUS 85075344.1y
  • Sep 20, 2030compositionUS 85075344.1y
  • Sep 20, 2030compositionUS 85075344.1y
  • Sep 20, 2030compositionUS 85075344.1y
  • Sep 20, 2030compositionUS 85075344.1y
  • Sep 20, 2030formulationUS 87163384.1y
  • Sep 20, 2030formulationUS 87163384.1y
  • Sep 20, 2030formulationUS 87163384.1y
  • Sep 20, 2030formulationUS 87163384.1y
  • Sep 20, 2030formulationUS 87163384.1y
  • Mar 29, 2030patentUS 9192606*PED3.6y
  • Mar 29, 2030patentUS 9192606*PED3.6y
  • Mar 29, 2030patentUS 9192606*PED3.6y
  • Mar 29, 2030patentUS 9192606*PED3.6y
  • Mar 29, 2030patentUS 9192606*PED3.6y
  • Feb 13, 2030patentUS 10646481*PED3.5y
  • Feb 13, 2030patentUS 10646481*PED3.5y
  • Feb 13, 2030patentUS 10646481*PED3.5y
  • Feb 13, 2030patentUS 10646481*PED3.5y
  • Feb 13, 2030patentUS 10646481*PED3.5y
  • Feb 13, 2030patentUS 11564916*PED3.5y
  • Feb 13, 2030patentUS 11564916*PED3.5y
  • Feb 13, 2030patentUS 11564916*PED3.5y
  • Feb 13, 2030patentUS 11564916*PED3.5y
  • Feb 13, 2030patentUS 11564916*PED3.5y
  • Feb 13, 2030patentUS 12458635*PED3.5y
  • Feb 13, 2030patentUS 12458635*PED3.5y
  • Feb 13, 2030patentUS 12458635*PED3.5y
  • Feb 13, 2030patentUS 12458635*PED3.5y
  • Feb 13, 2030patentUS 12458635*PED3.5y
  • Jan 2, 2030patentUS 8846718*PED3.4y
  • Jan 2, 2030patentUS 8846718*PED3.4y
  • Jan 2, 2030patentUS 8846718*PED3.4y
  • Jan 2, 2030patentUS 8846718*PED3.4y
  • Jan 2, 2030patentUS 8846718*PED3.4y
  • Sep 29, 2029formulationUS 91926063.2y
  • Sep 29, 2029formulationUS 91926063.2y
  • Sep 29, 2029formulationUS 91926063.2y
  • Sep 29, 2029formulationUS 91926063.2y
  • Sep 29, 2029formulationUS 91926063.2y
  • Aug 13, 2029formulationUS 106464813.0y
  • Aug 13, 2029formulationUS 106464813.0y
  • Aug 13, 2029formulationUS 106464813.0y
  • Aug 13, 2029formulationUS 106464813.0y
  • Aug 13, 2029formulationUS 106464813.0y
  • Aug 13, 2029method-of-use (U-3526)US 115649163.0y
  • Aug 13, 2029method-of-use (U-3526)US 115649163.0y
  • Aug 13, 2029method-of-use (U-3529)US 115649163.0y
  • Aug 13, 2029method-of-use (U-3529)US 115649163.0y
  • Aug 13, 2029method-of-use (U-3526)US 115649163.0y
  • Aug 13, 2029formulationUS 124586353.0y
  • Aug 13, 2029formulationUS 124586353.0y
  • Aug 13, 2029formulationUS 124586353.0y
  • Aug 13, 2029formulationUS 124586353.0y
  • Aug 13, 2029formulationUS 124586353.0y
  • Jul 2, 2029method-of-use (U-2375)US 88467182.9y
  • Jul 2, 2029method-of-use (U-2375)US 88467182.9y
  • Jul 2, 2029method-of-use (U-1908)US 88467182.9y
  • Jul 2, 2029method-of-use (U-3427)US 88467182.9y
  • Jul 2, 2029method-of-use (U-1908)US 88467182.9y
  • Jun 4, 2029patentUS 10076513*PED2.8y
  • Jun 4, 2029patentUS 10597384*PED2.8y
  • Jun 4, 2029patentUS 10597384*PED2.8y
  • Jun 4, 2029patentUS 10597384*PED2.8y
  • Jun 4, 2029patentUS 10597384*PED2.8y
  • Jun 4, 2029patentUS 10597384*PED2.8y
  • Jun 4, 2029patentUS 11052075*PED2.8y
  • Jun 4, 2029patentUS 11052075*PED2.8y
  • Jun 4, 2029patentUS 12065432*PED2.8y
  • Jun 4, 2029patentUS 12065432*PED2.8y
  • Jun 4, 2029patentUS 12065432*PED2.8y
  • Jun 4, 2029patentUS 12065432*PED2.8y
  • Jun 4, 2029patentUS 12065432*PED2.8y
  • Jun 4, 2029patentUS 8653103*PED2.8y
  • Jun 4, 2029patentUS 8653103*PED2.8y
  • Jun 4, 2029patentUS 8653103*PED2.8y
  • Jun 4, 2029patentUS 8653103*PED2.8y
  • Jun 4, 2029patentUS 8653103*PED2.8y
  • Jun 4, 2029patentUS 9150552*PED2.8y
  • Jun 4, 2029patentUS 9150552*PED2.8y
  • Jun 4, 2029patentUS 9150552*PED2.8y
  • Jun 4, 2029patentUS 9150552*PED2.8y
  • Jun 4, 2029patentUS 9150552*PED2.8y
  • Dec 4, 2028formulationUS 100765132.3y
  • Dec 4, 2028compositionUS 105973842.3y
  • Dec 4, 2028compositionUS 105973842.3y
  • Dec 4, 2028compositionUS 105973842.3y
  • Dec 4, 2028compositionUS 105973842.3y
  • Dec 4, 2028compositionUS 105973842.3y
  • Dec 4, 2028formulationUS 110520752.3y
  • Dec 4, 2028formulationUS 110520752.3y
  • Dec 4, 2028method-of-use (U-3984)US 120654322.3y
  • Dec 4, 2028method-of-use (U-3983)US 120654322.3y
  • Dec 4, 2028method-of-use (U-3983)US 120654322.3y
  • Dec 4, 2028method-of-use (U-3983)US 120654322.3y
  • Dec 4, 2028method-of-use (U-3984)US 120654322.3y
  • Dec 4, 2028formulationUS 86531032.3y
  • Dec 4, 2028formulationUS 86531032.3y
  • Dec 4, 2028formulationUS 86531032.3y
  • Dec 4, 2028formulationUS 86531032.3y
  • Dec 4, 2028formulationUS 86531032.3y
  • Dec 4, 2028method-of-use (U-2375)US 91505522.3y
  • Dec 4, 2028method-of-use (U-3427)US 91505522.3y
  • Dec 4, 2028method-of-use (U-1908)US 91505522.3y
  • Dec 4, 2028method-of-use (U-2375)US 91505522.3y
  • Dec 4, 2028method-of-use (U-1908)US 91505522.3y
  • Feb 5, 2028patentUS 8324242*PED1.5y
  • Feb 5, 2028patentUS 8324242*PED1.5y
  • Feb 5, 2028patentUS 8324242*PED1.5y
  • Feb 5, 2028patentUS 8324242*PED1.5y
  • Feb 5, 2028patentUS 8324242*PED1.5y
  • Nov 20, 2027patentUS 7495103*PED1.3y
  • Nov 20, 2027patentUS 7495103*PED1.3y
  • Nov 20, 2027patentUS 7495103*PED1.3y
  • Nov 20, 2027patentUS 7495103*PED1.3y
  • Nov 20, 2027patentUS 7495103*PED1.3y
  • Aug 5, 2027method-of-use (U-3424)US 83242421.0y
  • Aug 5, 2027method-of-use (U-2374)US 83242421.0y
  • Aug 5, 2027method-of-use (U-2374)US 83242421.0y
  • Aug 5, 2027method-of-use (U-1911)US 83242421.0y
  • Aug 5, 2027method-of-use (U-1911)US 83242421.0y
  • Jun 28, 2027patentUS 8410274*PED327d
  • Jun 28, 2027patentUS 8410274*PED327d
  • Jun 28, 2027patentUS 8410274*PED327d
  • Jun 28, 2027patentUS 8410274*PED327d
  • Jun 28, 2027patentUS 8410274*PED327d
  • Jun 28, 2027patentUS 8754224*PED327d
  • Jun 28, 2027patentUS 8754224*PED327d
  • Jun 28, 2027patentUS 8754224*PED327d
  • Jun 28, 2027patentUS 8754224*PED327d
  • Jun 28, 2027patentUS 8754224*PED327d
  • Jun 28, 2027patentUS 9670163*PED327d
  • Jun 28, 2027patentUS 9670163*PED327d
  • Jun 28, 2027patentUS 9670163*PED327d
  • Jun 28, 2027patentUS 9670163*PED327d
  • Jun 28, 2027patentUS 9670163*PED327d
  • Jun 28, 2027patentUS 9931334*PED327d
  • Jun 28, 2027patentUS 9931334*PED327d
  • Jun 28, 2027patentUS 9931334*PED327d
  • Jun 28, 2027patentUS 9931334*PED327d
  • Jun 28, 2027patentUS 9931334*PED327d
  • May 20, 2027compositionUS 7495103288d
  • May 20, 2027compositionUS 7495103288d
  • May 20, 2027compositionUS 7495103288d
  • May 20, 2027compositionUS 7495103288d
  • May 20, 2027compositionUS 7495103288d
  • May 8, 2027patentUS 7973038*PED276d
  • May 8, 2027patentUS 7973038*PED276d
  • May 8, 2027patentUS 7973038*PED276d
  • May 8, 2027patentUS 7973038*PED276d
  • May 8, 2027patentUS 7973038*PED276d
  • May 8, 2027patentUS 8741933*PED276d
  • May 8, 2027patentUS 8741933*PED276d
  • May 8, 2027patentUS 8741933*PED276d
  • May 8, 2027patentUS 8741933*PED276d
  • May 8, 2027patentUS 8741933*PED276d
  • May 8, 2027patentUS 9216969*PED276d
  • May 8, 2027patentUS 9216969*PED276d
  • May 8, 2027patentUS 9216969*PED276d
  • May 8, 2027patentUS 9216969*PED276d
  • May 8, 2027patentUS 9216969*PED276d
  • Dec 28, 2026formulationUS 8410274145d
  • Dec 28, 2026formulationUS 8410274145d
  • Dec 28, 2026formulationUS 8410274145d
  • Dec 28, 2026formulationUS 8410274145d
  • Dec 28, 2026formulationUS 8410274145d
  • Dec 28, 2026compositionUS 8754224145d
  • Dec 28, 2026compositionUS 8754224145d
  • Dec 28, 2026compositionUS 8754224145d
  • Dec 28, 2026compositionUS 8754224145d
  • Dec 28, 2026compositionUS 8754224145d
  • Dec 28, 2026formulationUS 9670163145d
  • Dec 28, 2026formulationUS 9670163145d
  • Dec 28, 2026formulationUS 9670163145d
  • Dec 28, 2026formulationUS 9670163145d
  • Dec 28, 2026formulationUS 9670163145d
  • Dec 28, 2026formulationUS 9931334145d
  • Dec 28, 2026formulationUS 9931334145d
  • Dec 28, 2026formulationUS 9931334145d
  • Dec 28, 2026formulationUS 9931334145d
  • Dec 28, 2026formulationUS 9931334145d
  • Nov 8, 2026method-of-use (U-1973)US 797303895d
  • Nov 8, 2026method-of-use (U-2374)US 797303895d
  • Nov 8, 2026method-of-use (U-3424)US 797303895d
  • Nov 8, 2026method-of-use (U-1973)US 797303895d
  • Nov 8, 2026method-of-use (U-2374)US 797303895d
  • Nov 8, 2026method-of-use (U-2374)US 874193395d
  • Nov 8, 2026method-of-use (U-1717)US 874193395d
  • Nov 8, 2026method-of-use (U-2374)US 874193395d
  • Nov 8, 2026method-of-use (U-3424)US 874193395d
  • Nov 8, 2026method-of-use (U-1909)US 874193395d
  • Nov 8, 2026compositionUS 921696995d
  • Nov 8, 2026formulationUS 921696995d
  • Nov 8, 2026formulationUS 921696995d
  • Nov 8, 2026formulationUS 921696995d
  • Nov 8, 2026formulationUS 921696995d

FDA exclusivities (12)

  • Mar 2, 2030PEDPediatric (6mo bonus)3.6y
  • Mar 2, 2030PEDPediatric (6mo bonus)3.6y
  • Mar 2, 2030PEDPediatric (6mo bonus)3.6y
  • Sep 2, 2029ODE-408Orphan Drug (7y)3.1y
  • Sep 2, 2029ODE-408Orphan Drug (7y)3.1y
  • Sep 2, 2029ODE-408Orphan Drug (7y)3.1y
  • Jun 13, 2028PEDPediatric (6mo bonus)1.9y
  • Jun 13, 2028PEDPediatric (6mo bonus)1.9y
  • Jun 13, 2028PEDPediatric (6mo bonus)1.9y
  • Dec 13, 2027M-14Method (3y)1.4y
  • Dec 13, 2027M-14Method (3y)1.4y
  • Dec 13, 2027M-14Method (3y)1.4y

News(0)

no news has mentioned this drug yet

brand
Orkambi
generic
(ivacaftor + lumacaftor)
MOA
12.1 Mechanism of Action The CFTR protein is a chloride channel present at the surface of epithelial cells in multiple organs. The F508del mutation results in protein misfolding, causing a defect in cellular processing and trafficking that targets the protein for degradation and therefore reduces the quantity of CFTR at the cell surface. The small amount of F508del-CFTR that reaches the cell surface is less stable and has low channel-open probability (defective gating activity) compared to wild-type CFTR protein. Lumacaftor improves the conformational stability of F508del-CFTR, resulting in increased processing and trafficking of mature protein to the cell surface. Ivacaftor is a CFTR potentiator that facilitates increased chloride transport by potentiating the channel-open probability (or gating) of the CFTR protein at the cell surface. In vitro studies have demonstrated that both lumacaftor and ivacaftor act directly on the CFTR protein in primary human bronchial epithelial cultures and other cell lines harboring the F508del-CFTR mutation to increase the quantity, stability, and function of F508del-CFTR at the cell surface, resulting in increased chloride ion transport. In vitro responses do not necessarily correspond to in vivo pharmacodynamic response or clinical benefit.
indication
Cystic Fibrosis
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 59m ago
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