NDAORALGRANULE
Approved
Jul 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
17
Data completeness
4/8 — Partial
SINGULAIR (montelukast sodium) by Merck & Co. is leukotriene receptor antagonists [moa]. First approved in 2002.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SINGULAIR (montelukast sodium) is an oral leukotriene receptor antagonist approved in 2002 for asthma and allergic rhinitis. It works by blocking leukotriene receptors on airway and inflammatory cells, reducing inflammation and bronchoconstriction. The drug is available as a granule formulation for convenient dosing across age groups.
$7.0MPart D
LOE ApproachingDeclining
Mature product approaching loss of exclusivity with limited Part D utilization; commercial team focus likely shifting to generic transition and retention strategy rather than growth.
Mechanism of Action
Leukotriene Receptor Antagonists
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (17)
Bioequivalence Study of Montelukast Sodium Oral Thin Film and Chewable Tablet in Fasted Healthy Volunteers
Started Dec 2018
30 enrolled
Healthy Volunteers
Bioequivalence Study of Montelukast Sodium Oral Thin Film and Chewable Tablet in Fed Healthy Volunteers
Started Nov 2018
30 enrolled
Healthy Volunteers
Relative Bioavailability Study of Two Montelukast Sodium (GW483100) 5 Milligrams (mg) Chewable Tablets and One Reference Montelukast Sodium 5 mg Chewable Tablet in Healthy Adult Subjects
Started Feb 2015
18 enrolled
Respiratory Disorders
A Bioequivalence Study of Montelukast From Asmakast 10mg Tabs (Sandoz, Egypt) & Singulair 10mg Tabs (Merck)
Started Aug 2014
26 enrolled
Healthy
Bioequivalence Study of Montelukast From Asmakast 5mg Chewable Tab.(Sandoz, Egypt) & Singulair 5mg Chewable Tab.(Merck)
Started Apr 2014
24 enrolled
Healthy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.