TheraRadar
Data updated: May 26, 2026

SYMDEKO (COPACKAGED) (ivacaftor)

Chloride Channel Activation Potentiators
Orphan Drug Breakthrough Therapy Priority Review Fast Track
Respiratory Approved 2018-02-12

SYMDEKO (COPACKAGED) is indicated for the treatment of Cystic Fibrosis.

Source: FDA Label • Vertex Pharmaceuticals • Cystic Fibrosis Transmembrane Conductance Regulator Potentiator
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How SYMDEKO (COPACKAGED) Works

Ivacaftor is a potentiator of the CFTR protein, a chloride channel located on the surface of epithelial cells in multiple organs. The drug increases chloride transport by potentiating the channel open probability, or gating, of the CFTR protein at the cell surface. The total level of chloride transport is determined by the amount of CFTR protein present at the cell surface and the responsiveness of the specific mutant protein to the drug. In vitro studies utilize a threshold of at least a 10% net increase of normal chloride transport over baseline to predict clinical benefit.

Source: FDA Label
3
Indications
--
Phase 3 Trials
3
Priority Reviews
8
Years on Market

Details

Status
Prescription
First Approved
2018-02-12
Patent Cliff
2035

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

Vertex Pharmaceuticals
Active Ingredient: IVACAFTOR , IVACAFTOR, TEZACAFTOR

SYMDEKO (COPACKAGED) Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
14 FDA actions from 2018 to 2026 · 2 indication expansions
Mar 2026 SUPPL
Label · Labeling
Label
Sep 2025 SUPPL
Label · Labeling
FDA Letter Label
Aug 2023 SUPPL
Label · Labeling
Label

What SYMDEKO (COPACKAGED) Treats

1 indications

SYMDEKO (COPACKAGED) is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Cystic Fibrosis
Source: FDA Label

SYMDEKO (COPACKAGED) Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

1

Same target(s) AND same indication — head-to-head.

ALYFTREK
Vertex Pharmaceuticals
2024 1 indic.

MoA expansion candidates

3

Same target(s), different indications — where else is this mechanism being explored?

TRIKAFTA (COPACKAGED)
Vertex Pharmaceuticals
2019
MYTESI
NAPO PHARMS
2012 2 indic.

Indication competitors

3

Same indication, different mechanism — what else might this patient receive?

PULMOZYME
Roche
1993 2 indic.
VITAMIN K1
Pfizer
1983 10 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to SYMDEKO (COPACKAGED)

3 of 12

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ALYFTREK
DEUTIVACAFTOR
1 shared
Vertex Pharmaceuticals
Shared indications:
Cystic Fibrosis
BETHKIS
TOBRAMYCIN
1 shared
CHIESI
Shared indications:
Cystic Fibrosis
CAYSTON
AZTREONAM
1 shared
Gilead Sciences
Shared indications:
Cystic Fibrosis
View all 12 similar drugs Pro
📋

Clinical Trial Registry

40 trials
Trial Sponsor ID Phase Status Title
NCT06237335 RCT2100-101 2024-512169-15 Ph 2 recruiting A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF
NCT02070744 results posted VX13-661-103 Ph 2 completed Study 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 Expansion
NCT03624101 results posted IRB-300001363 Ph 4 terminated Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations
NCT04126473 EL-004 Ph 2 completed A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD in Cystic Fibrosis Patients With at Least 1 G542X Allele
NCT04135495 EL-012 Ph 2 completed A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD of ELX-02 in Cystic Fibrosis Patients With G542X Allele
NCT04066751 IRB-300003967 P30DK072482 Ph 2 withdrawn The Multicenter Topic Trial
NCT02871778 CLEAN-PCD results posted PS-G202 2015-004917-26 Ph 2 completed Clearing Lungs With ENaC Inhibition in Primary Ciliary Dyskinesia
NCT02508207 results posted VX14-661-111 Ph 2 completed A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
NCT03068312 results posted VX16-770-127 2017-000457-39 Ph 3 completed A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C→T or D1152H CFTR Mutation
NCT02730208 results posted VX15-661-112 Ph 2 completed A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
NCT03150719 results posted VX16-661-114 2017-000540-18 Ph 3 completed A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF)
NCT02412111 results posted VX14-661-109 Ph 3 completed A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to Ivacaftor
NCT02742519 results posted VX15-770-123 2015-001267-39 Ph 3 terminated A Study to Evaluate Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation
NCT02934698 results posted Pro00052526 Ph 3 completed An Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing Mutations
NCT02392234 results posted VX14-661-108 2014-004788-18 Ph 3 completed A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation
NCT02347657 results posted VX14-661-106 Ph 3 completed A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor
NCT02516410 results posted VX14-661-107 2014-004787-37 Ph 3 completed A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation
NCT01531673 results posted VX11-661-101 2011-003821-93 Ph 2 completed Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) Mutation
NCT02390219 results posted VX14-809-106 Ph 3 completed Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease
NCT03029455 VX16-659-001 2016-003048-35 Ph 1 completed A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic Fibrosis
NCT01897233 results posted VX13-809-011 Ph 3 completed Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
NCT01707290 KONTINUE results posted VX12-770-112 2012-000389-39 Ph 3 completed Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR Mutation
NCT01931839 results posted VX12-809-105 Ph 3 completed A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis
NCT01946412 results posted VX11-770-109 Ph 3 completed Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating Mutation
NCT01807949 TRANSPORT results posted VX12-809-104 Ph 3 completed A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation
NCT01705145 results posted VX11-770-108 KIWI Ph 3 completed Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating Mutation
NCT01225211 results posted VX09-809-102 2010-020413-90 Ph 2 completed Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation
NCT00953706 DISCOVER results posted VX08-770-104 2009-010261-23 Ph 2 terminated Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Homozygous for the F508del-CFTR Mutation
NCT01807923 TRAFFIC results posted VX12-809-103 Ph 3 completed A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation
NCT01117012 results posted VX08-770-105 PERSIST Ph 3 completed Rollover Study of VX-770 in Cystic Fibrosis Subjects
NCT01685801 results posted VX12-770-113 Ph 2 completed Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis and Residual CFTR Function
NCT01614457 KONDUCT results posted VX11-770-110 Ph 3 completed Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have the R117H-CF Transmembrane Conductance Regulator (CFTR) Mutation (KONDUCT)
NCT01614470 KONNECTION results posted VX12-770-111 Ph 3 completed Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating Mutation
NCT01910415 VX12-809-008 Ph 1 completed Phase 1, QT/QTC Interval Study in Healthy Subjects
NCT01899105 VX13-809-012 Ph 1 completed A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor
NCT02015507 VX13-770-017 Ph 1 completed An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on Ivacaftor and VX-661 in Combination With Ivacaftor
NCT01768663 VX12-809-009 Ph 1 completed A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects
NCT01262352 results posted VX10-770-106 Ph 2 completed Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation
NCT00909532 STRIVE results posted VX08-770-102 Ph 3 completed Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D Mutation
NCT00909727 ENVISION results posted VX08-770-103 Ph 3 completed Study of Ivacaftor in Cystic Fibrosis Subjects Aged 6 to 11 Years With the G551D Mutation
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

SYMDEKO (COPACKAGED) FDA Label Details

Indications & Usage

FDA Label (PDF)

SYMDEKO (COPACKAGED) is indicated for the treatment of Cystic Fibrosis.

View full patent landscape →
26 OB patents · 12 families · 489 international docs across 38 countries

SYMDEKO (COPACKAGED) Patents & Exclusivity

Latest Patent: Apr 2035
Exclusivity: Dec 2027

Patents (26 active)

US10206877 Expires Apr 14, 2035
US11951212 Expires Apr 14, 2035
US9012496 Expires Jul 15, 2033
US10058546 Expires Jul 15, 2033
USRE50453 Expires Jul 10, 2031
US11578062 Expires Mar 25, 2031
US10081621 Expires Mar 25, 2031
US12458635 Expires Aug 13, 2029
US11564916 Expires Aug 13, 2029
US10646481 Expires Aug 13, 2029
US8415387 Expires Nov 12, 2027
US8324242 Expires Aug 5, 2027
US7776905 Expires Jun 3, 2027
US7495103 Expires May 20, 2027
US8598181 Expires May 1, 2027
US7645789 Expires May 1, 2027
US8623905 Expires May 1, 2027
US10239867 Expires Apr 9, 2027
US10022352 Expires Apr 9, 2027
US9974781 Expires Apr 9, 2027
US11639347 Expires Apr 9, 2027
US9670163 Expires Dec 28, 2026
US9931334 Expires Dec 28, 2026
US8410274 Expires Dec 28, 2026
US8754224 Expires Dec 28, 2026
US8354427 Expires Jul 6, 2026

Exclusivity

ODE-247 Until Jun 2026
ODE-335 Until Dec 2027
ODE-247 Until Jun 2026
ODE-335 Until Dec 2027
ODE-247 Until Jun 2026
ODE-335 Until Dec 2027
ODE-247 Until Jun 2026
ODE-335 Until Dec 2027
Source: FDA Orange Book

Pro Intelligence Preview

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2035
  • • 130 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 12 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA210491 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.