TheraRadar
Data updated: Jul 17, 2026

NINTEDANIB ESYLATE · Apotex

Generic · see OFEV Trial Activity: Declining 10 active trials
Approved 2014-10-15

NINTEDANIB ESYLATE is FDA-approved to treat 3 conditions (same as OFEV).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Boehringer Ingelheim conducting 38 trials (44%)
98 indications explored (Broad Platform)
→ idiopathic pulmonary fibrosis (14 trials)
→ healthy (12 trials)
→ carcinoma, non-small-cell lung (8 trials)
2
Indications
--
Phase 3 Trials
11
Years on Market

Details

Status
Prescription
First Approved
2014-10-15
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Apotex Novartis DEXCEL GLENMARK PHARMS LTD Cipla HUMANWELL PURACAP Dr. Reddy's
Active Ingredient: NINTEDANIB ESYLATE

NINTEDANIB ESYLATE Approval History

Original
New Indication
New Form
Label Update
14 FDA actions from 2026 to 2026
Jul 2026 ORIGINAL
Update
FDA Letter
Apr 2026 ORIGINAL
Update
FDA Letter

What NINTEDANIB ESYLATE Treats

3 indications

NINTEDANIB ESYLATE is approved for 3 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Idiopathic Pulmonary Fibrosis
  • Interstitial Lung Disease
  • Systemic Sclerosis-Associated Interstitial Lung Disease

Same approved indications as OFEV (same active ingredient).

Source: FDA Label
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

NINTEDANIB ESYLATE FDA Label Details

Indications & Usage

NINTEDANIB ESYLATE is FDA-approved to treat 3 conditions — same approved indications as OFEV.

Looking for the branded version?

OFEV

Full clinical data, patents, trials, and competitive landscape for nintedanib esylate.

See OFEV

Data Sources

FDA Approval: ANDA219227 → Trials: ClinicalTrials.gov →

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