TheraRadar
Data updated: May 26, 2026

EXKIVITY (mobocertinib succinate)

Orphan Drug Breakthrough Therapy Priority Review Accelerated Approval Fast Track
Oncology Approved 2021-09-15
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
4
Years on Market

Details

Status
Discontinued
First Approved
2021-09-15
Patent Cliff
2035

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE

Companies

Takeda
Active Ingredient: MOBOCERTINIB SUCCINATE

EXKIVITY Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2021 to 2023
Sep 2023 SUPPL
Label · Labeling
FDA Letter Label
Mar 2023 SUPPL
Label · Labeling
FDA Letter Label
Sep 2021 ORIGINAL Priority
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What EXKIVITY Treats

1 FDA approvals

Originally approved for its first indication in 2021 .

  • Other (1)
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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.

EXKIVITY FDA Label Details

View full patent landscape →
2 OB patents · 1 families · 85 international docs across 42 countries

EXKIVITY Patents & Exclusivity

Latest Patent: May 2035
Exclusivity: Sep 2028

Patents (2 active)

US10227342 Expires May 13, 2035
US9796712 Expires May 13, 2035

Exclusivity

NCE Until Sep 2026
ODE-374 Until Sep 2028
Source: FDA Orange Book

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Deep insights for EXKIVITY

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2035
  • • 2 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA215310 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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