AGGRENOX
LOE ApproachingNDAORALCAPSULE, EXTENDED RELEASEPriority Review
Approved
Nov 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
4/8 — Partial
Priority Review
AGGRENOX by Boehringer Ingelheim is 12. Approved for stroke in patients, completed ischemic stroke due to thrombosis. First approved in 1999.
Drug data last refreshed 10h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AGGRENOX is a fixed-dose combination of aspirin and dipyridamole in extended-release capsule form indicated for reducing the risk of stroke in patients with completed ischemic stroke or transient ischemic attack. It works through additive antiplatelet effects: dipyridamole increases adenosine concentrations to inhibit platelet aggregation via cAMP elevation, while aspirin irreversibly inhibits cyclooxygenase to block thromboxane A2 production.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%); diminishing team investment expected as generic entry approaches.
Mechanism of Action
12.1 Mechanism of Action The antithrombotic action of AGGRENOX is the result of the additive antiplatelet effects of dipyridamole and aspirin. Dipyridamole Dipyridamole inhibits the uptake of adenosine into platelets, endothelial cells and erythrocytes in vitro and in vivo ; the inhibition occurs…
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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.