TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

TRIKAFTA (COPACKAGED)

ELEXACAFTOR, IVACAFTOR, TEZACAFTOR
Approved 2019-10-21
Jump to: Indications Approvals Trials Competitors Safety Patents
5
Indications
--
Phase 3 Trials
5
Priority Reviews
6
Years on Market

Details

Status
Prescription
First Approved
2019-10-21
Routes
ORAL
Dosage Forms
TABLET, GRANULES

Companies

Vertex Pharmaceuticals
Active Ingredient: ELEXACAFTOR, IVACAFTOR, TEZACAFTOR , IVACAFTOR

TRIKAFTA (COPACKAGED) Approval History

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What TRIKAFTA (COPACKAGED) Treats

5 FDA approvals

Originally approved for its first indication in 2019 . Covers 5 distinct patient populations.

  • Other (5)
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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.

TRIKAFTA (COPACKAGED) FDA Label Details

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TRIKAFTA (COPACKAGED) Patents & Exclusivity

Latest Patent: Jul 2038
Exclusivity: Dec 2031

Patents (420 active)

US12350262 Expires Jul 17, 2038
US11179367 Expires Dec 8, 2037
US10793547 Expires Dec 8, 2037
US11517564 Expires Dec 8, 2037
US11453655 Expires Dec 8, 2037
US10758534 Expires Oct 6, 2035
US11426407 Expires Oct 6, 2035
US9012496 Expires Jul 15, 2033
US12214083 Expires Feb 27, 2033
US11147770 Expires Feb 27, 2033
+ 410 more patents

Exclusivity

M-313 Until Dec 2027
ODE-275 Until Oct 2026
ODE-323 Until Dec 2027
ODE-357 Until Jun 2028
ODE-512 Until Dec 2031
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA212273 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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