Active-ingredient Dossier

Montelukast Sodium

Active-ingredient Dossier for Montelukast Sodium (leukotriene receptor antagonist). Australian brands, products, PBS listings, PBAC outcomes — compiled…

What is

Montelukast Sodium Montelukast Sodium is a leukotriene receptor antagonist.

Australian brands containing

Montelukast Sodium — MONTELUKAST — SINGULAIR — APO-MONTELUKAST — APX-MONTELUKAST — LUKAFAST — LUKAIR — MONTELAIR — MONTELUKAST LUPIN — MONTELUKAST-WGR — APL-MONTELUKAST TABS

Therapeutic areas

Montelukast Sodium is registered in the respiratory therapeutic area, with 13 brands on the ARTG containing this ingredient.

Sponsor landscape

The ingredient is marketed by six sponsors: Arrotex Pharmaceuticals, Torrent, Organon Pharma, Accord Healthcare, Strides Pharma Science, and Generic Health.

PBS and regulatory activity

One brand containing Montelukast Sodium has PBS-listed items, with the latest PBS schedule date of 1 May 2026. The latest PBAC outcome on record is dated 1 November 2017, and two brands have PBAC outcomes recorded. No AusPARs are on record for this ingredient.