NDAORALTABLET
Approved
Sep 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
6/8 — Strong
ACCOLATE (zafirlukast) by PharmaIN is leukotriene receptor antagonists [moa]. Approved for asthma. First approved in 1996.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACCOLATE (zafirlukast) is an oral leukotriene receptor antagonist approved in 1996 for asthma management. It works by blocking leukotriene receptors in the airways, reducing inflammation and bronchoconstriction in asthmatic patients. This small-molecule tablet is administered orally as a maintenance therapy.
$0.008BPart D
LOE ApproachingDeclining
Product is in late-stage lifecycle with minimal Part D claims (21 in 2023), indicating a contracted patient base and reduced team investment typical of LOE-approaching brands.
Mechanism of Action
Leukotriene Receptor Antagonists
Pharmacologic Class:
Leukotriene Receptor Antagonist
Indications (1)
Clinical Trials (2)
Crossover Study of Zafirlukast in Preventing Allergen-induced Signs and Symptoms in Response to Cat Dander Challenge
Started Dec 2025
12 enrolled
Allergy to Cats
Bioequivalence Study of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
Started Dec 2007
44 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.