NDAORALCAPSULE, EXTENDED RELEASE
Approved
Sep 2015
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
DURLAZA (aspirin) by Bayer is [acetylsalicylic acid (asa)] inhibits prostaglandin synthesis resulting in inhibition of platelet aggregation for their lifespan of about 7-10 days. Approved for coronary artery disease, acute ischemic stroke, myocardial infarction and 2 more indications. First approved in 2015.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DURLAZA is an extended-release oral aspirin (acetylsalicylic acid) approved in 2015 for cardiovascular indications including coronary artery disease, acute ischemic stroke, myocardial infarction, and acute coronary syndrome. It works by irreversibly inhibiting COX-1 and blocking platelet aggregation for 7–10 days through suppression of thromboxane A2 synthesis. The extended-release formulation provides sustained antiplatelet effects with a single daily dose.
Peak
Product is in peak commercial phase with established market presence, but faces moderate competitive pressure (30/100) requiring strong field execution and managed care positioning.
Mechanism of Action
[acetylsalicylic acid (ASA)] inhibits prostaglandin synthesis resulting in inhibition of platelet aggregation for their lifespan of about 7-10 days. The acetyl group of aspirin binds with a serine residue of cyclooxygenase-1 (COX-1) , resulting in irreversible inactivation of the enzyme. Inhibition…
Indications (5)
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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.