drug
(ivacaftor + lumacaftor)
Marketedupdated 3mo agoby $VERX Vertex, Inc.
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 6Small 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%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Mar 18, 2016
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Apr 6, 2016
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
May 18, 2016
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Aug 5, 2016
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 6, 2016
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 28, 2016
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Jan 25, 2018
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Aug 7, 2018
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Aug 15, 2018
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 2, 2022
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 2, 2022
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Aug 3, 2023
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Aug 3, 2023
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Dec 13, 2024
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Dec 13, 2024
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 25, 2025
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 25, 2025
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Mar 17, 2026
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Mar 17, 2026
approval
$VERX12.39-7.54%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Patent cliff
source: FDA Orange Bookfirst 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
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