TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

NYMALIZE

NIMODIPINE
Approved 2013-05-10
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
12
Years on Market

Details

Status
Discontinued
First Approved
2013-05-10
Routes
ORAL
Dosage Forms
SOLUTION

Companies

AZURITY
Active Ingredient: NIMODIPINE

NYMALIZE Approval History

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What NYMALIZE Treats

1 FDA approvals

Originally approved for its first indication in 2013 .

  • Other (1)
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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.

NYMALIZE FDA Label Details

Pro

NYMALIZE Patents & Exclusivity

Latest Patent: Apr 2038

Patents (12 active)

US11413277 Expires Apr 16, 2038
US12186308 Expires Apr 16, 2038
US10342787 Expires Apr 16, 2038
US10576070 Expires Apr 16, 2038
US11207306 Expires Apr 16, 2038
US11806338 Expires Apr 16, 2038
+ 2 more patents
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA203340 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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