drug
(ivacaftor + lumacaftor)
Marketedupdated 5mo 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
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Mar 18, 2016
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Apr 6, 2016
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
May 18, 2016
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Aug 5, 2016
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 6, 2016
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 28, 2016
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Jan 25, 2018
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Aug 7, 2018
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Aug 15, 2018
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 2, 2022
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 2, 2022
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Aug 3, 2023
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Aug 3, 2023
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Dec 13, 2024
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Dec 13, 2024
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 25, 2025
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Sep 25, 2025
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Mar 17, 2026
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Mar 17, 2026
approval
$VERX11.15+0.81%
ORKAMBI (IVACAFTOR) — FDA approval
(ivacaftor + lumacaftor)
→
Patent cliff
source: FDA Orange Bookfirst barrier falls
Nov 8, 2026
38 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*PED4.7y
- Jun 11, 2031patentUS 8993600*PED4.7y
- Jun 11, 2031patentUS 8993600*PED4.7y
- Jun 11, 2031patentUS 8993600*PED4.7y
- Jun 11, 2031patentUS 8993600*PED4.7y
- Mar 20, 2031patentUS 8507534*PED4.5y
- Mar 20, 2031patentUS 8507534*PED4.5y
- Mar 20, 2031patentUS 8507534*PED4.5y
- Mar 20, 2031patentUS 8507534*PED4.5y
- Mar 20, 2031patentUS 8507534*PED4.5y
- Mar 20, 2031patentUS 8716338*PED4.5y
- Mar 20, 2031patentUS 8716338*PED4.5y
- Mar 20, 2031patentUS 8716338*PED4.5y
- Mar 20, 2031patentUS 8716338*PED4.5y
- Mar 20, 2031patentUS 8716338*PED4.5y
- Dec 11, 2030formulationUS 89936004.2y
- Dec 11, 2030formulationUS 89936004.2y
- Dec 11, 2030formulationUS 89936004.2y
- Dec 11, 2030formulationUS 89936004.2y
- Dec 11, 2030formulationUS 89936004.2y
- Sep 20, 2030compositionUS 85075344.0y
- Sep 20, 2030compositionUS 85075344.0y
- Sep 20, 2030compositionUS 85075344.0y
- Sep 20, 2030compositionUS 85075344.0y
- Sep 20, 2030compositionUS 85075344.0y
- Sep 20, 2030formulationUS 87163384.0y
- Sep 20, 2030formulationUS 87163384.0y
- Sep 20, 2030formulationUS 87163384.0y
- Sep 20, 2030formulationUS 87163384.0y
- Sep 20, 2030formulationUS 87163384.0y
- Mar 29, 2030patentUS 9192606*PED3.5y
- Mar 29, 2030patentUS 9192606*PED3.5y
- Mar 29, 2030patentUS 9192606*PED3.5y
- Mar 29, 2030patentUS 9192606*PED3.5y
- Mar 29, 2030patentUS 9192606*PED3.5y
- Feb 13, 2030patentUS 10646481*PED3.4y
- Feb 13, 2030patentUS 10646481*PED3.4y
- Feb 13, 2030patentUS 10646481*PED3.4y
- Feb 13, 2030patentUS 10646481*PED3.4y
- Feb 13, 2030patentUS 10646481*PED3.4y
- Feb 13, 2030patentUS 11564916*PED3.4y
- Feb 13, 2030patentUS 11564916*PED3.4y
- Feb 13, 2030patentUS 11564916*PED3.4y
- Feb 13, 2030patentUS 11564916*PED3.4y
- Feb 13, 2030patentUS 11564916*PED3.4y
- Feb 13, 2030patentUS 12458635*PED3.4y
- Feb 13, 2030patentUS 12458635*PED3.4y
- Feb 13, 2030patentUS 12458635*PED3.4y
- Feb 13, 2030patentUS 12458635*PED3.4y
- Feb 13, 2030patentUS 12458635*PED3.4y
- Jan 2, 2030patentUS 8846718*PED3.3y
- Jan 2, 2030patentUS 8846718*PED3.3y
- Jan 2, 2030patentUS 8846718*PED3.3y
- Jan 2, 2030patentUS 8846718*PED3.3y
- Jan 2, 2030patentUS 8846718*PED3.3y
- Sep 29, 2029formulationUS 91926063.0y
- Sep 29, 2029formulationUS 91926063.0y
- Sep 29, 2029formulationUS 91926063.0y
- Sep 29, 2029formulationUS 91926063.0y
- Sep 29, 2029formulationUS 91926063.0y
- Aug 13, 2029formulationUS 106464812.9y
- Aug 13, 2029formulationUS 106464812.9y
- Aug 13, 2029formulationUS 106464812.9y
- Aug 13, 2029formulationUS 106464812.9y
- Aug 13, 2029formulationUS 106464812.9y
- Aug 13, 2029method-of-use (U-3526)US 115649162.9y
- Aug 13, 2029method-of-use (U-3526)US 115649162.9y
- Aug 13, 2029method-of-use (U-3529)US 115649162.9y
- Aug 13, 2029method-of-use (U-3529)US 115649162.9y
- Aug 13, 2029method-of-use (U-3526)US 115649162.9y
- Aug 13, 2029formulationUS 124586352.9y
- Aug 13, 2029formulationUS 124586352.9y
- Aug 13, 2029formulationUS 124586352.9y
- Aug 13, 2029formulationUS 124586352.9y
- Aug 13, 2029formulationUS 124586352.9y
- Jul 2, 2029method-of-use (U-2375)US 88467182.8y
- Jul 2, 2029method-of-use (U-2375)US 88467182.8y
- Jul 2, 2029method-of-use (U-1908)US 88467182.8y
- Jul 2, 2029method-of-use (U-3427)US 88467182.8y
- Jul 2, 2029method-of-use (U-1908)US 88467182.8y
- Jun 4, 2029patentUS 10076513*PED2.7y
- Jun 4, 2029patentUS 10597384*PED2.7y
- Jun 4, 2029patentUS 10597384*PED2.7y
- Jun 4, 2029patentUS 10597384*PED2.7y
- Jun 4, 2029patentUS 10597384*PED2.7y
- Jun 4, 2029patentUS 10597384*PED2.7y
- Jun 4, 2029patentUS 11052075*PED2.7y
- Jun 4, 2029patentUS 11052075*PED2.7y
- Jun 4, 2029patentUS 12065432*PED2.7y
- Jun 4, 2029patentUS 12065432*PED2.7y
- Jun 4, 2029patentUS 12065432*PED2.7y
- Jun 4, 2029patentUS 12065432*PED2.7y
- Jun 4, 2029patentUS 12065432*PED2.7y
- Jun 4, 2029patentUS 8653103*PED2.7y
- Jun 4, 2029patentUS 8653103*PED2.7y
- Jun 4, 2029patentUS 8653103*PED2.7y
- Jun 4, 2029patentUS 8653103*PED2.7y
- Jun 4, 2029patentUS 8653103*PED2.7y
- Jun 4, 2029patentUS 9150552*PED2.7y
- Jun 4, 2029patentUS 9150552*PED2.7y
- Jun 4, 2029patentUS 9150552*PED2.7y
- Jun 4, 2029patentUS 9150552*PED2.7y
- Jun 4, 2029patentUS 9150552*PED2.7y
- Dec 4, 2028formulationUS 100765132.2y
- Dec 4, 2028compositionUS 105973842.2y
- Dec 4, 2028compositionUS 105973842.2y
- Dec 4, 2028compositionUS 105973842.2y
- Dec 4, 2028compositionUS 105973842.2y
- Dec 4, 2028compositionUS 105973842.2y
- Dec 4, 2028formulationUS 110520752.2y
- Dec 4, 2028formulationUS 110520752.2y
- Dec 4, 2028method-of-use (U-3984)US 120654322.2y
- Dec 4, 2028method-of-use (U-3983)US 120654322.2y
- Dec 4, 2028method-of-use (U-3983)US 120654322.2y
- Dec 4, 2028method-of-use (U-3983)US 120654322.2y
- Dec 4, 2028method-of-use (U-3984)US 120654322.2y
- Dec 4, 2028formulationUS 86531032.2y
- Dec 4, 2028formulationUS 86531032.2y
- Dec 4, 2028formulationUS 86531032.2y
- Dec 4, 2028formulationUS 86531032.2y
- Dec 4, 2028formulationUS 86531032.2y
- Dec 4, 2028method-of-use (U-2375)US 91505522.2y
- Dec 4, 2028method-of-use (U-3427)US 91505522.2y
- Dec 4, 2028method-of-use (U-1908)US 91505522.2y
- Dec 4, 2028method-of-use (U-2375)US 91505522.2y
- Dec 4, 2028method-of-use (U-1908)US 91505522.2y
- Feb 5, 2028patentUS 8324242*PED1.3y
- Feb 5, 2028patentUS 8324242*PED1.3y
- Feb 5, 2028patentUS 8324242*PED1.3y
- Feb 5, 2028patentUS 8324242*PED1.3y
- Feb 5, 2028patentUS 8324242*PED1.3y
- Nov 20, 2027patentUS 7495103*PED1.1y
- Nov 20, 2027patentUS 7495103*PED1.1y
- Nov 20, 2027patentUS 7495103*PED1.1y
- Nov 20, 2027patentUS 7495103*PED1.1y
- Nov 20, 2027patentUS 7495103*PED1.1y
- Aug 5, 2027method-of-use (U-3424)US 8324242308d
- Aug 5, 2027method-of-use (U-2374)US 8324242308d
- Aug 5, 2027method-of-use (U-2374)US 8324242308d
- Aug 5, 2027method-of-use (U-1911)US 8324242308d
- Aug 5, 2027method-of-use (U-1911)US 8324242308d
- Jun 28, 2027patentUS 8410274*PED270d
- Jun 28, 2027patentUS 8410274*PED270d
- Jun 28, 2027patentUS 8410274*PED270d
- Jun 28, 2027patentUS 8410274*PED270d
- Jun 28, 2027patentUS 8410274*PED270d
- Jun 28, 2027patentUS 8754224*PED270d
- Jun 28, 2027patentUS 8754224*PED270d
- Jun 28, 2027patentUS 8754224*PED270d
- Jun 28, 2027patentUS 8754224*PED270d
- Jun 28, 2027patentUS 8754224*PED270d
- Jun 28, 2027patentUS 9670163*PED270d
- Jun 28, 2027patentUS 9670163*PED270d
- Jun 28, 2027patentUS 9670163*PED270d
- Jun 28, 2027patentUS 9670163*PED270d
- Jun 28, 2027patentUS 9670163*PED270d
- Jun 28, 2027patentUS 9931334*PED270d
- Jun 28, 2027patentUS 9931334*PED270d
- Jun 28, 2027patentUS 9931334*PED270d
- Jun 28, 2027patentUS 9931334*PED270d
- Jun 28, 2027patentUS 9931334*PED270d
- May 20, 2027compositionUS 7495103231d
- May 20, 2027compositionUS 7495103231d
- May 20, 2027compositionUS 7495103231d
- May 20, 2027compositionUS 7495103231d
- May 20, 2027compositionUS 7495103231d
- May 8, 2027patentUS 7973038*PED219d
- May 8, 2027patentUS 7973038*PED219d
- May 8, 2027patentUS 7973038*PED219d
- May 8, 2027patentUS 7973038*PED219d
- May 8, 2027patentUS 7973038*PED219d
- May 8, 2027patentUS 8741933*PED219d
- May 8, 2027patentUS 8741933*PED219d
- May 8, 2027patentUS 8741933*PED219d
- May 8, 2027patentUS 8741933*PED219d
- May 8, 2027patentUS 8741933*PED219d
- May 8, 2027patentUS 9216969*PED219d
- May 8, 2027patentUS 9216969*PED219d
- May 8, 2027patentUS 9216969*PED219d
- May 8, 2027patentUS 9216969*PED219d
- May 8, 2027patentUS 9216969*PED219d
- Dec 28, 2026formulationUS 841027488d
- Dec 28, 2026formulationUS 841027488d
- Dec 28, 2026formulationUS 841027488d
- Dec 28, 2026formulationUS 841027488d
- Dec 28, 2026formulationUS 841027488d
- Dec 28, 2026compositionUS 875422488d
- Dec 28, 2026compositionUS 875422488d
- Dec 28, 2026compositionUS 875422488d
- Dec 28, 2026compositionUS 875422488d
- Dec 28, 2026compositionUS 875422488d
- Dec 28, 2026formulationUS 967016388d
- Dec 28, 2026formulationUS 967016388d
- Dec 28, 2026formulationUS 967016388d
- Dec 28, 2026formulationUS 967016388d
- Dec 28, 2026formulationUS 967016388d
- Dec 28, 2026formulationUS 993133488d
- Dec 28, 2026formulationUS 993133488d
- Dec 28, 2026formulationUS 993133488d
- Dec 28, 2026formulationUS 993133488d
- Dec 28, 2026formulationUS 993133488d
- Nov 8, 2026method-of-use (U-1973)US 797303838d
- Nov 8, 2026method-of-use (U-2374)US 797303838d
- Nov 8, 2026method-of-use (U-3424)US 797303838d
- Nov 8, 2026method-of-use (U-1973)US 797303838d
- Nov 8, 2026method-of-use (U-2374)US 797303838d
- Nov 8, 2026method-of-use (U-2374)US 874193338d
- Nov 8, 2026method-of-use (U-1717)US 874193338d
- Nov 8, 2026method-of-use (U-2374)US 874193338d
- Nov 8, 2026method-of-use (U-3424)US 874193338d
- Nov 8, 2026method-of-use (U-1909)US 874193338d
- Nov 8, 2026compositionUS 921696938d
- Nov 8, 2026formulationUS 921696938d
- Nov 8, 2026formulationUS 921696938d
- Nov 8, 2026formulationUS 921696938d
- Nov 8, 2026formulationUS 921696938d
FDA exclusivities (12)
- Mar 2, 2030PEDPediatric (6mo bonus)3.4y
- Mar 2, 2030PEDPediatric (6mo bonus)3.4y
- Mar 2, 2030PEDPediatric (6mo bonus)3.4y
- Sep 2, 2029ODE-408Orphan Drug (7y)2.9y
- Sep 2, 2029ODE-408Orphan Drug (7y)2.9y
- Sep 2, 2029ODE-408Orphan Drug (7y)2.9y
- Jun 13, 2028PEDPediatric (6mo bonus)1.7y
- Jun 13, 2028PEDPediatric (6mo bonus)1.7y
- Jun 13, 2028PEDPediatric (6mo bonus)1.7y
- Dec 13, 2027M-14Method (3y)1.2y
- Dec 13, 2027M-14Method (3y)1.2y
- Dec 13, 2027M-14Method (3y)1.2y
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