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 3d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
YOSPRALA is a fixed-dose combination oral tablet containing aspirin (antiplatelet/anti-inflammatory) and omeprazole (proton pump inhibitor) approved to reduce the risk of gastrointestinal bleeding in patients requiring aspirin therapy. Aspirin inhibits prostaglandin synthesis and platelet aggregation via acetylation of cyclooxygenase, while omeprazole suppresses gastric acid secretion by blocking the H+/K+-ATPase pump. This combination addresses a major safety concern in aspirin-treated populations.
Peak6.8 years to LOE
Product is at peak lifecycle stage with no direct competitors, suggesting stable commercial performance and established team structures.
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.