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

patents (209)

Apr 14, 2035formulationUS 10206877
Apr 14, 2035formulationUS 10206877
Apr 14, 2035formulationUS 11951212
Aug 27, 2033patentUS 10272046*PED
Aug 27, 2033patentUS 10272046*PED
Aug 27, 2033patentUS 10272046*PED
Aug 27, 2033patentUS 10272046*PED
Aug 27, 2033patentUS 10272046*PED
Aug 27, 2033patentUS 11147770*PED
Aug 27, 2033patentUS 11147770*PED
Aug 27, 2033patentUS 11147770*PED
Aug 27, 2033patentUS 11147770*PED
Aug 27, 2033patentUS 11147770*PED
Aug 27, 2033patentUS 11752106*PED
Aug 27, 2033patentUS 11752106*PED
Aug 27, 2033patentUS 11752106*PED
Aug 27, 2033patentUS 11752106*PED
Aug 27, 2033patentUS 11752106*PED
Aug 27, 2033patentUS 12214083*PED
Aug 27, 2033patentUS 12214083*PED
Aug 27, 2033patentUS 12214083*PED
Aug 27, 2033patentUS 12214083*PED
Aug 27, 2033patentUS 12214083*PED
Aug 27, 2033patentUS 8883206*PED
Aug 27, 2033patentUS 8883206*PED
Aug 27, 2033patentUS 8883206*PED
Aug 27, 2033patentUS 8883206*PED
Aug 27, 2033patentUS 8883206*PED
Jul 15, 2033method-of-use (U-3023)US 10058546
Jul 15, 2033method-of-use (U-3022)US 10058546
Jul 15, 2033method-of-use (U-2248)US 9012496
Jul 15, 2033method-of-use (U-2248)US 9012496
Feb 27, 2033formulationUS 10272046
Feb 27, 2033formulationUS 10272046
Feb 27, 2033formulationUS 10272046
Feb 27, 2033formulationUS 10272046
Feb 27, 2033formulationUS 10272046
Feb 27, 2033formulationUS 11147770
Feb 27, 2033formulationUS 11147770
Feb 27, 2033formulationUS 11147770
Feb 27, 2033formulationUS 11147770
Feb 27, 2033formulationUS 11147770
Feb 27, 2033formulationUS 11752106
Feb 27, 2033formulationUS 11752106
Feb 27, 2033formulationUS 11752106
Feb 27, 2033formulationUS 11752106
Feb 27, 2033formulationUS 11752106
Feb 27, 2033formulationUS 12214083
Feb 27, 2033formulationUS 12214083
Feb 27, 2033formulationUS 12214083
Feb 27, 2033formulationUS 12214083
Feb 27, 2033formulationUS 12214083
Feb 27, 2033formulationUS 8883206
Feb 27, 2033formulationUS 8883206
Feb 27, 2033formulationUS 8883206
Feb 27, 2033formulationUS 8883206
Feb 27, 2033formulationUS 8883206
Jul 10, 2031compositionUS RE504534.9y
Jul 10, 2031compositionUS RE504534.9y
Mar 25, 2031formulationUS 100816214.6y
Mar 25, 2031formulationUS 100816214.6y
Mar 25, 2031formulationUS 115780624.6y
Mar 25, 2031formulationUS 115780624.6y
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 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 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
Feb 13, 2030patentUS 12458635*PED3.5y
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, 2029formulationUS 106464813.0y
Aug 13, 2029formulationUS 106464813.0y
Aug 13, 2029formulationUS 106464813.0y
Aug 13, 2029method-of-use (U-3527)US 115649163.0y
Aug 13, 2029method-of-use (U-3530)US 115649163.0y
Aug 13, 2029method-of-use (U-3528)US 115649163.0y
Aug 13, 2029method-of-use (U-3528)US 115649163.0y
Aug 13, 2029method-of-use (U-3527)US 115649163.0y
Aug 13, 2029method-of-use (U-3603)US 115649163.0y
Aug 13, 2029method-of-use (U-3528)US 115649163.0y
Aug 13, 2029method-of-use (U-3603)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
Aug 13, 2029formulationUS 124586353.0y
Aug 13, 2029formulationUS 124586353.0y
Aug 13, 2029formulationUS 124586353.0y
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
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
Nov 20, 2027patentUS 7495103*PED1.3y
Nov 12, 2027method-of-use (U-2246)US 84153871.2y
Nov 12, 2027method-of-use (U-2246)US 84153871.2y
Aug 5, 2027method-of-use (U-2246)US 8324242354d
Aug 5, 2027method-of-use (U-3609)US 8324242354d
Aug 5, 2027method-of-use (U-1906)US 8324242354d
Aug 5, 2027method-of-use (U-1906)US 8324242354d
Aug 5, 2027method-of-use (U-2963)US 8324242354d
Aug 5, 2027method-of-use (U-2246)US 8324242354d
Aug 5, 2027method-of-use (U-1311)US 8324242354d
Aug 5, 2027method-of-use (U-3609)US 8324242354d
Jun 28, 2027patentUS 8410274*PED316d
Jun 28, 2027patentUS 8410274*PED316d
Jun 28, 2027patentUS 8410274*PED316d
Jun 28, 2027patentUS 8410274*PED316d
Jun 28, 2027patentUS 8410274*PED316d
Jun 28, 2027patentUS 8410274*PED316d
Jun 28, 2027patentUS 8754224*PED316d
Jun 28, 2027patentUS 8754224*PED316d
Jun 28, 2027patentUS 8754224*PED316d
Jun 28, 2027patentUS 8754224*PED316d
Jun 28, 2027patentUS 8754224*PED316d
Jun 28, 2027patentUS 8754224*PED316d
Jun 28, 2027patentUS 9670163*PED316d
Jun 28, 2027patentUS 9670163*PED316d
Jun 28, 2027patentUS 9670163*PED316d
Jun 28, 2027patentUS 9670163*PED316d
Jun 28, 2027patentUS 9670163*PED316d
Jun 28, 2027patentUS 9670163*PED316d
Jun 3, 2027compositionUS 7776905291d
Jun 3, 2027compositionUS 7776905291d
May 20, 2027compositionUS 7495103277d
May 20, 2027compositionUS 7495103277d
May 20, 2027compositionUS 7495103277d
May 20, 2027compositionUS 7495103277d
May 20, 2027compositionUS 7495103277d
May 20, 2027compositionUS 7495103277d
May 20, 2027compositionUS 7495103277d
May 20, 2027compositionUS 7495103277d
May 1, 2027compositionUS 7645789258d
May 1, 2027compositionUS 7645789258d
May 1, 2027method-of-use (U-2246)US 8598181258d
May 1, 2027method-of-use (U-2246)US 8598181258d
May 1, 2027compositionUS 8623905258d
May 1, 2027compositionUS 8623905258d
Apr 9, 2027formulationUS 10022352236d
Apr 9, 2027formulationUS 10022352236d
Apr 9, 2027compositionUS 10239867236d
Apr 9, 2027compositionUS 10239867236d
Apr 9, 2027compositionUS 11639347236d
Apr 9, 2027compositionUS 11639347236d
Apr 9, 2027formulationUS 9974781236d
Apr 9, 2027formulationUS 9974781236d
Jan 6, 2027patentUS 8354427*PED143d
Jan 6, 2027patentUS 8354427*PED143d
Jan 6, 2027patentUS 8354427*PED143d
Jan 6, 2027patentUS 8354427*PED143d
Jan 6, 2027patentUS 8354427*PED143d
Jan 6, 2027patentUS 8354427*PED143d
Dec 28, 2026formulationUS 8410274134d
Dec 28, 2026formulationUS 8410274134d
Dec 28, 2026formulationUS 8410274134d
Dec 28, 2026formulationUS 8410274134d
Dec 28, 2026formulationUS 8410274134d
Dec 28, 2026formulationUS 8410274134d
Dec 28, 2026formulationUS 8410274134d
Dec 28, 2026formulationUS 8410274134d
Dec 28, 2026compositionUS 8754224134d
Dec 28, 2026compositionUS 8754224134d
Dec 28, 2026compositionUS 8754224134d
Dec 28, 2026compositionUS 8754224134d
Dec 28, 2026compositionUS 8754224134d
Dec 28, 2026compositionUS 8754224134d
Dec 28, 2026compositionUS 8754224134d
Dec 28, 2026compositionUS 8754224134d
Dec 28, 2026formulationUS 9670163134d
Dec 28, 2026formulationUS 9670163134d
Dec 28, 2026formulationUS 9670163134d
Dec 28, 2026formulationUS 9670163134d
Dec 28, 2026formulationUS 9670163134d
Dec 28, 2026formulationUS 9670163134d
Dec 28, 2026formulationUS 9670163134d
Dec 28, 2026formulationUS 9670163134d
Dec 28, 2026formulationUS 9931334134d
Dec 28, 2026formulationUS 9931334134d
Jul 6, 2026method-of-use (U-1311)US 8354427
Jul 6, 2026method-of-use (U-3021)US 8354427
Jul 6, 2026method-of-use (U-3608)US 8354427
Jul 6, 2026method-of-use (U-3608)US 8354427
Jul 6, 2026method-of-use (U-1311)US 8354427
Jul 6, 2026method-of-use (U-1905)US 8354427
Jul 6, 2026method-of-use (U-2964)US 8354427
Jul 6, 2026method-of-use (U-3021)US 8354427

FDA exclusivities (36)

Nov 3, 2030PEDPediatric (6mo bonus)4.2y
Nov 3, 2030PEDPediatric (6mo bonus)4.2y
May 3, 2030ODE-435Orphan Drug (7y)3.7y
May 3, 2030ODE-435Orphan Drug (7y)3.7y
Nov 22, 2028PEDPediatric (6mo bonus)2.3y
Nov 22, 2028PEDPediatric (6mo bonus)2.3y
Nov 22, 2028PEDPediatric (6mo bonus)2.3y
Nov 22, 2028PEDPediatric (6mo bonus)2.3y
Nov 22, 2028PEDPediatric (6mo bonus)2.3y
Jun 21, 2028PEDPediatric (6mo bonus)1.8y
Jun 21, 2028PEDPediatric (6mo bonus)1.8y
Jun 21, 2028PEDPediatric (6mo bonus)1.8y
Jun 21, 2028PEDPediatric (6mo bonus)1.8y
May 22, 2028M-14Method (3y)1.8y
May 22, 2028M-14Method (3y)1.8y
May 22, 2028M-14Method (3y)1.8y
May 22, 2028M-14Method (3y)1.8y
May 22, 2028M-14Method (3y)1.8y
Dec 21, 2027ODE-338Orphan Drug (7y)1.3y
Dec 21, 2027ODE-335Orphan Drug (7y)1.3y
Dec 21, 2027ODE-335Orphan Drug (7y)1.3y
Dec 21, 2027ODE-338Orphan Drug (7y)1.3y
Dec 21, 2027ODE-338Orphan Drug (7y)1.3y
Dec 21, 2027ODE-338Orphan Drug (7y)1.3y
Nov 3, 2026PEDPediatric (6mo bonus)79d
Nov 3, 2026PEDPediatric (6mo bonus)79d
Oct 29, 2026PEDPediatric (6mo bonus)74d
Oct 29, 2026PEDPediatric (6mo bonus)74d
Oct 29, 2026PEDPediatric (6mo bonus)74d
Jun 21, 2026ODE-247Orphan Drug (7y)
Jun 21, 2026ODE-247Orphan Drug (7y)
May 3, 2026NPPNew Product (3y)
May 3, 2026NPPNew Product (3y)
Apr 29, 2026ODE-236Orphan Drug (7y)
Apr 29, 2026ODE-236Orphan Drug (7y)
Apr 29, 2026ODE-236Orphan Drug (7y)

News(0)

no news has mentioned this drug yet

brand

Kalydeco

generic

ivacaftor

MOA

12.1 Mechanism of Action Ivacaftor is a potentiator of the CFTR protein. The CFTR protein is a chloride channel present at the surface of epithelial cells in multiple organs. Ivacaftor facilitates increased chloride transport by potentiating the channel open probability (or gating) of CFTR protein located at the cell surface. The overall level of ivacaftor-mediated CFTR chloride transport is dependent on the amount of CFTR protein at the cell surface and how responsive a particular mutant CFTR protein is to ivacaftor potentiation. CFTR Chloride Transport Assay in Fischer Rat Thyroid (FRT) cells expressing mutant CFTR The chloride transport response of mutant CFTR protein to ivacaftor was determined in Ussing chamber electrophysiology studies using a panel of FRT cell lines transfected with individual CFTR mutations. Ivacaftor increased chloride transport in FRT cells expressing CFTR mutations that result in CFTR protein being delivered to the cell surface. The in vitro CFTR chloride transport response threshold was designated as a net increase of at least 10% of normal over baseline because it is predictive or reasonably expected to predict clinical benefit. For individual mutations, the magnitude of the net change over baseline in CFTR-mediated chloride transport in vitro is not correlated with the magnitude of clinical response. A patient must have at least one CFTR mutation responsive to ivacaftor to be indicated. Note that splice site mutations cannot be studied in the FRT assay. Evidence of clinical efficacy exists for non-canonical splice mutations 2789+5G→A , 3272-26A→G , 3849+10kbC→T , 711+3A→G and E831X and these are listed in Table 3 below [see also Clinical Studies (14.4) ] . The G970R mutation causes a splicing defect resulting in little-to-no CFTR protein at the cell surface that can be potentiated by ivacaftor [see Clinical Studies (14.2) ] . Ivacaftor also increased chloride transport in cultured human bronchial epithelial (HBE) cells derived from CF

indication

Cystic Fibrosis

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

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ivacaftor

Marketedupdated 3mo ago

by $VERX Vertex, Inc.

Approved

community read0 votes

🐶 often sniffed alongside

top 8

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(21)

approval · 21

KALYDECO (IVACAFTOR) — FDA approval

KALYDECO (IVACAFTOR) — FDA approval

KALYDECO (IVACAFTOR) — FDA approval

KALYDECO (IVACAFTOR) — FDA approval

KALYDECO (IVACAFTOR) — FDA approval

SYMDEKO (COPACKAGED) (IVACAFTOR) — FDA approval

KALYDECO (IVACAFTOR) — FDA approval

KALYDECO (IVACAFTOR) — FDA approval

SYMDEKO (COPACKAGED) (IVACAFTOR) — FDA approval

SYMDEKO (COPACKAGED) (IVACAFTOR) — FDA approval

KALYDECO (IVACAFTOR) — FDA approval

KALYDECO (IVACAFTOR) — FDA approval

SYMDEKO (COPACKAGED) (IVACAFTOR) — FDA approval

KALYDECO (IVACAFTOR) — FDA approval

SYMDEKO (COPACKAGED) (IVACAFTOR) — FDA approval

KALYDECO (IVACAFTOR) — FDA approval

KALYDECO (IVACAFTOR) — FDA approval

SYMDEKO (COPACKAGED) (IVACAFTOR) — FDA approval

KALYDECO (IVACAFTOR) — FDA approval

KALYDECO (IVACAFTOR) — FDA approval

SYMDEKO (COPACKAGED) (IVACAFTOR) — FDA approval

ivacaftor

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Trials studying ivacaftor

phase1Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosisrecruitingn=255
phase2A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CFrecruitingn=192
phase2Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansioncompletedn=40
phase2The Topic Trial - Study to Determine the Safety and Efficacy of Ivacaftorcompletedn=40
phase1Bioequivalence and Food Effect Bioavailability Study of Lumacaftor Film-Coated Tabletscompletedn=39
phase2A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD in Cystic Fibrosis Patients With at Least 1 G542X Allelecompletedn=17
phase2Gut Imaging for Function & Transit in Cystic Fibrosis Study 2completedn=12

Patent cliff

source: FDA Orange Book

first barrier falls

Oct 29, 2026

74 days

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

patents (209)

Apr 14, 2035formulationUS 10206877
Apr 14, 2035formulationUS 10206877
Apr 14, 2035formulationUS 11951212
Aug 27, 2033patentUS 10272046*PED
Aug 27, 2033patentUS 10272046*PED
Aug 27, 2033patentUS 10272046*PED
Aug 27, 2033patentUS 10272046*PED
Aug 27, 2033patentUS 10272046*PED
Aug 27, 2033patentUS 11147770*PED
Aug 27, 2033patentUS 11147770*PED
Aug 27, 2033patentUS 11147770*PED
Aug 27, 2033patentUS 11147770*PED
Aug 27, 2033patentUS 11147770*PED
Aug 27, 2033patentUS 11752106*PED
Aug 27, 2033patentUS 11752106*PED
Aug 27, 2033patentUS 11752106*PED
Aug 27, 2033patentUS 11752106*PED
Aug 27, 2033patentUS 11752106*PED
Aug 27, 2033patentUS 12214083*PED
Aug 27, 2033patentUS 12214083*PED
Aug 27, 2033patentUS 12214083*PED
Aug 27, 2033patentUS 12214083*PED
Aug 27, 2033patentUS 12214083*PED
Aug 27, 2033patentUS 8883206*PED
Aug 27, 2033patentUS 8883206*PED
Aug 27, 2033patentUS 8883206*PED
Aug 27, 2033patentUS 8883206*PED
Aug 27, 2033patentUS 8883206*PED
Jul 15, 2033method-of-use (U-3023)US 10058546
Jul 15, 2033method-of-use (U-3022)US 10058546
Jul 15, 2033method-of-use (U-2248)US 9012496
Jul 15, 2033method-of-use (U-2248)US 9012496
Feb 27, 2033formulationUS 10272046
Feb 27, 2033formulationUS 10272046
Feb 27, 2033formulationUS 10272046
Feb 27, 2033formulationUS 10272046
Feb 27, 2033formulationUS 10272046
Feb 27, 2033formulationUS 11147770
Feb 27, 2033formulationUS 11147770
Feb 27, 2033formulationUS 11147770
Feb 27, 2033formulationUS 11147770
Feb 27, 2033formulationUS 11147770
Feb 27, 2033formulationUS 11752106
Feb 27, 2033formulationUS 11752106
Feb 27, 2033formulationUS 11752106
Feb 27, 2033formulationUS 11752106
Feb 27, 2033formulationUS 11752106
Feb 27, 2033formulationUS 12214083
Feb 27, 2033formulationUS 12214083
Feb 27, 2033formulationUS 12214083
Feb 27, 2033formulationUS 12214083
Feb 27, 2033formulationUS 12214083
Feb 27, 2033formulationUS 8883206
Feb 27, 2033formulationUS 8883206
Feb 27, 2033formulationUS 8883206
Feb 27, 2033formulationUS 8883206
Feb 27, 2033formulationUS 8883206
Jul 10, 2031compositionUS RE504534.9y
Jul 10, 2031compositionUS RE504534.9y
Mar 25, 2031formulationUS 100816214.6y
Mar 25, 2031formulationUS 100816214.6y
Mar 25, 2031formulationUS 115780624.6y
Mar 25, 2031formulationUS 115780624.6y
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 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 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
Feb 13, 2030patentUS 12458635*PED3.5y
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, 2029formulationUS 106464813.0y
Aug 13, 2029formulationUS 106464813.0y
Aug 13, 2029formulationUS 106464813.0y
Aug 13, 2029method-of-use (U-3527)US 115649163.0y
Aug 13, 2029method-of-use (U-3530)US 115649163.0y
Aug 13, 2029method-of-use (U-3528)US 115649163.0y
Aug 13, 2029method-of-use (U-3528)US 115649163.0y
Aug 13, 2029method-of-use (U-3527)US 115649163.0y
Aug 13, 2029method-of-use (U-3603)US 115649163.0y
Aug 13, 2029method-of-use (U-3528)US 115649163.0y
Aug 13, 2029method-of-use (U-3603)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
Aug 13, 2029formulationUS 124586353.0y
Aug 13, 2029formulationUS 124586353.0y
Aug 13, 2029formulationUS 124586353.0y
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
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
Nov 20, 2027patentUS 7495103*PED1.3y
Nov 12, 2027method-of-use (U-2246)US 84153871.2y
Nov 12, 2027method-of-use (U-2246)US 84153871.2y
Aug 5, 2027method-of-use (U-2246)US 8324242354d
Aug 5, 2027method-of-use (U-3609)US 8324242354d
Aug 5, 2027method-of-use (U-1906)US 8324242354d
Aug 5, 2027method-of-use (U-1906)US 8324242354d
Aug 5, 2027method-of-use (U-2963)US 8324242354d
Aug 5, 2027method-of-use (U-2246)US 8324242354d
Aug 5, 2027method-of-use (U-1311)US 8324242354d
Aug 5, 2027method-of-use (U-3609)US 8324242354d
Jun 28, 2027patentUS 8410274*PED316d
Jun 28, 2027patentUS 8410274*PED316d
Jun 28, 2027patentUS 8410274*PED316d
Jun 28, 2027patentUS 8410274*PED316d
Jun 28, 2027patentUS 8410274*PED316d
Jun 28, 2027patentUS 8410274*PED316d
Jun 28, 2027patentUS 8754224*PED316d
Jun 28, 2027patentUS 8754224*PED316d
Jun 28, 2027patentUS 8754224*PED316d
Jun 28, 2027patentUS 8754224*PED316d
Jun 28, 2027patentUS 8754224*PED316d
Jun 28, 2027patentUS 8754224*PED316d
Jun 28, 2027patentUS 9670163*PED316d
Jun 28, 2027patentUS 9670163*PED316d
Jun 28, 2027patentUS 9670163*PED316d
Jun 28, 2027patentUS 9670163*PED316d
Jun 28, 2027patentUS 9670163*PED316d
Jun 28, 2027patentUS 9670163*PED316d
Jun 3, 2027compositionUS 7776905291d
Jun 3, 2027compositionUS 7776905291d
May 20, 2027compositionUS 7495103277d
May 20, 2027compositionUS 7495103277d
May 20, 2027compositionUS 7495103277d
May 20, 2027compositionUS 7495103277d
May 20, 2027compositionUS 7495103277d
May 20, 2027compositionUS 7495103277d
May 20, 2027compositionUS 7495103277d
May 20, 2027compositionUS 7495103277d
May 1, 2027compositionUS 7645789258d
May 1, 2027compositionUS 7645789258d
May 1, 2027method-of-use (U-2246)US 8598181258d
May 1, 2027method-of-use (U-2246)US 8598181258d
May 1, 2027compositionUS 8623905258d
May 1, 2027compositionUS 8623905258d
Apr 9, 2027formulationUS 10022352236d
Apr 9, 2027formulationUS 10022352236d
Apr 9, 2027compositionUS 10239867236d
Apr 9, 2027compositionUS 10239867236d
Apr 9, 2027compositionUS 11639347236d
Apr 9, 2027compositionUS 11639347236d
Apr 9, 2027formulationUS 9974781236d
Apr 9, 2027formulationUS 9974781236d
Jan 6, 2027patentUS 8354427*PED143d
Jan 6, 2027patentUS 8354427*PED143d
Jan 6, 2027patentUS 8354427*PED143d
Jan 6, 2027patentUS 8354427*PED143d
Jan 6, 2027patentUS 8354427*PED143d
Jan 6, 2027patentUS 8354427*PED143d
Dec 28, 2026formulationUS 8410274134d
Dec 28, 2026formulationUS 8410274134d
Dec 28, 2026formulationUS 8410274134d
Dec 28, 2026formulationUS 8410274134d
Dec 28, 2026formulationUS 8410274134d
Dec 28, 2026formulationUS 8410274134d
Dec 28, 2026formulationUS 8410274134d
Dec 28, 2026formulationUS 8410274134d
Dec 28, 2026compositionUS 8754224134d
Dec 28, 2026compositionUS 8754224134d
Dec 28, 2026compositionUS 8754224134d
Dec 28, 2026compositionUS 8754224134d
Dec 28, 2026compositionUS 8754224134d
Dec 28, 2026compositionUS 8754224134d
Dec 28, 2026compositionUS 8754224134d
Dec 28, 2026compositionUS 8754224134d
Dec 28, 2026formulationUS 9670163134d
Dec 28, 2026formulationUS 9670163134d
Dec 28, 2026formulationUS 9670163134d
Dec 28, 2026formulationUS 9670163134d
Dec 28, 2026formulationUS 9670163134d
Dec 28, 2026formulationUS 9670163134d
Dec 28, 2026formulationUS 9670163134d
Dec 28, 2026formulationUS 9670163134d
Dec 28, 2026formulationUS 9931334134d
Dec 28, 2026formulationUS 9931334134d
Jul 6, 2026method-of-use (U-1311)US 8354427
Jul 6, 2026method-of-use (U-3021)US 8354427
Jul 6, 2026method-of-use (U-3608)US 8354427
Jul 6, 2026method-of-use (U-3608)US 8354427
Jul 6, 2026method-of-use (U-1311)US 8354427
Jul 6, 2026method-of-use (U-1905)US 8354427
Jul 6, 2026method-of-use (U-2964)US 8354427
Jul 6, 2026method-of-use (U-3021)US 8354427

FDA exclusivities (36)

Nov 3, 2030PEDPediatric (6mo bonus)4.2y
Nov 3, 2030PEDPediatric (6mo bonus)4.2y
May 3, 2030ODE-435Orphan Drug (7y)3.7y
May 3, 2030ODE-435Orphan Drug (7y)3.7y
Nov 22, 2028PEDPediatric (6mo bonus)2.3y
Nov 22, 2028PEDPediatric (6mo bonus)2.3y
Nov 22, 2028PEDPediatric (6mo bonus)2.3y
Nov 22, 2028PEDPediatric (6mo bonus)2.3y
Nov 22, 2028PEDPediatric (6mo bonus)2.3y
Jun 21, 2028PEDPediatric (6mo bonus)1.8y
Jun 21, 2028PEDPediatric (6mo bonus)1.8y
Jun 21, 2028PEDPediatric (6mo bonus)1.8y
Jun 21, 2028PEDPediatric (6mo bonus)1.8y
May 22, 2028M-14Method (3y)1.8y
May 22, 2028M-14Method (3y)1.8y
May 22, 2028M-14Method (3y)1.8y
May 22, 2028M-14Method (3y)1.8y
May 22, 2028M-14Method (3y)1.8y
Dec 21, 2027ODE-338Orphan Drug (7y)1.3y
Dec 21, 2027ODE-335Orphan Drug (7y)1.3y
Dec 21, 2027ODE-335Orphan Drug (7y)1.3y
Dec 21, 2027ODE-338Orphan Drug (7y)1.3y
Dec 21, 2027ODE-338Orphan Drug (7y)1.3y
Dec 21, 2027ODE-338Orphan Drug (7y)1.3y
Nov 3, 2026PEDPediatric (6mo bonus)79d
Nov 3, 2026PEDPediatric (6mo bonus)79d
Oct 29, 2026PEDPediatric (6mo bonus)74d
Oct 29, 2026PEDPediatric (6mo bonus)74d
Oct 29, 2026PEDPediatric (6mo bonus)74d
Jun 21, 2026ODE-247Orphan Drug (7y)
Jun 21, 2026ODE-247Orphan Drug (7y)
May 3, 2026NPPNew Product (3y)
May 3, 2026NPPNew Product (3y)
Apr 29, 2026ODE-236Orphan Drug (7y)
Apr 29, 2026ODE-236Orphan Drug (7y)
Apr 29, 2026ODE-236Orphan Drug (7y)

News(0)

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brand

Kalydeco

generic

ivacaftor

MOA

indication

Cystic Fibrosis

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 20m ago

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ivacaftor

🐶 often sniffed alongside

indications

all catalysts(21)

Trials studying ivacaftor

Patent cliff

patents (209)

FDA exclusivities (36)

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Report a data issue

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ivacaftor

🐶 often sniffed alongside

indications

all catalysts(21)

Trials studying ivacaftor

Patent cliff

patents (209)

FDA exclusivities (36)

News(0)

Report a data issue

comments(0)