Wednesday, July 8, 2026

Drug profile · INN

montelukast sodium

montelukast sodium (MONTELUKAST SODIUM) is a cysteinyl leukotriene receptor 1 antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 1
Pipeline programs 2
News articles 0
Drug details — montelukast sodium
US status
approved
Class
Route
ORAL
Patents
1
Programs
2
Data quality
0.89

Quick answer

montelukast sodium (MONTELUKAST SODIUM) is a cysteinyl leukotriene receptor 1 antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN montelukast sodium
Brand MONTELUKAST SODIUM
Mechanism Cysteinyl leukotriene receptor 1 antagonist
Target Cysteinyl leukotriene receptor 1
Route ORAL
Formulation TABLET

Mechanism of action

Cysteinyl leukotriene receptor 1 antagonist

Primary target: Cysteinyl leukotriene receptor 1

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. 61186372NSC2005 Phase 2 · Janssen-Cilag International N.V · EGFR-mutated Advanced or Metastatic Non-small Cell Lung Canc
  2. Montelukast Approved · First People's Hospital · Sinusitis

Related & competitor drugs

  1. zafirlukast Cysteinyl leukotriene receptor 1 antagonist
  1. US 7547787

    Processes for preparing montelukast sodium

    Expires Mon Jun 11 2029 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is montelukast sodium?

montelukast sodium (MONTELUKAST SODIUM) is a cysteinyl leukotriene receptor 1 antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for montelukast sodium?

MONTELUKAST SODIUM is a marketed brand name for montelukast sodium. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of montelukast sodium?

montelukast sodium has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.