TRIKAFTA (COPACKAGED) (elexacaftor, ivacaftor, tezacaftor)
TRIKAFTA is a combination of elexacaftor, tezacaftor, and ivacaftor (CFTR modulators) indicated for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one F508del mutation in the CFTR gene.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-10-21
- Patent Cliff
- 2038
- Routes
- ORAL
- Dosage Forms
- TABLET, GRANULE
Companies
TRIKAFTA (COPACKAGED) Approval History
What TRIKAFTA (COPACKAGED) Treats
6 FDA approvalsOriginally approved for its first indication in 2019 . Covers 6 distinct patient populations.
- Other (6)
Other
(6 approvals)- • Approved indication (Oct 2019) PriorityLabel Letter
- • Approved indication (Dec 2020) PriorityLabel Letter
- • Approved indication (Jun 2021) PriorityLabel Letter
- • Approved indication (Apr 2023) PriorityLabel Letter
- • Approved indication (Dec 2024) PriorityLabel Letter
- • Approved indication (Mar 2026) Priority NewLabel Letter
TRIKAFTA (COPACKAGED) Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05743946 | STUDY00004736 | Ph 4 | completed | Trikafta for Patients With Non-cystic Fibrosis Bronchiectasis |
| NCT03506061 results posted | IRB00108656 300001205, R01HL139876 | Ph 2 | completed | Trikafta in Cystic Fibrosis Patients |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
TRIKAFTA (COPACKAGED) FDA Label Details
TRIKAFTA (COPACKAGED) Patents & Exclusivity
Patents (35 active)
Exclusivity
Pro Intelligence Preview
Deep insights for TRIKAFTA (COPACKAGED)
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 578 active patents
Trial Analysis
- • 3 total trials
- • Stage: Mature
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment