NDAORALTABLET, DELAYED RELEASE
Approved
Sep 2016
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
YOSPRALA (aspirin; omeprazole) by Teva is (acetylsalicylic acid) is an inhibitor of both prostaglandin synthesis and platelet aggregation. Approved for gastrointestinal bleeding due to aspirin. First approved in 2016.
Drug data last refreshed 23h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
YOSPRALA is a fixed-dose combination of aspirin (acetylsalicylic acid) and omeprazole approved specifically to reduce gastrointestinal bleeding risk in aspirin users. Aspirin inhibits platelet aggregation and prostaglandin synthesis via COX inhibition, while omeprazole suppresses gastric acid secretion by blocking the H+/K+-ATPase proton pump. This combination addresses a key safety concern in aspirin therapy by co-delivering gastroprotection.
Peak6.5 years to LOE
Product is in peak commercial phase with stable market position; teams are focused on maintaining market share and managing promotional efficiency.
Mechanism of Action
(acetylsalicylic acid) is an inhibitor of both prostaglandin synthesis and platelet aggregation. The differences in activity between aspirin and salicylic acid are thought to be due to the acetyl group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase…
Indications (1)
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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.