NDAORALTABLET, DELAYED RELEASE
Approved
Dec 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
ARTHROTEC (diclofenac sodium and misoprostol) by Pfizer is sodium/misoprostol is a combination product containing diclofenac sodium, an nsaid with analgesic, anti-inflammatory and antipyretic properties, and misoprostol, a gi mucosal protective prostaglandin-1 (pge1) analog. Approved for prostaglandin e1 analog [epc], the signs, symptoms of osteoarthritis and 6 more indications. First approved in 1997.
Drug data last refreshed 13h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ARTHROTEC is a fixed-dose oral combination of diclofenac sodium (NSAID) and misoprostol (PGE1 analog) indicated for osteoarthritis and rheumatoid arthritis in patients at high risk of NSAID-induced gastrointestinal ulcers. Diclofenac inhibits COX-1 and COX-2 to reduce pain and inflammation, while misoprostol protects the gastric mucosa by increasing bicarbonate and mucus secretion. This synergistic approach addresses both therapeutic efficacy and GI safety tolerability.
LOE Approaching
LOE-approaching product with low current spending ($0M recorded) signals reduced investment and smaller, maintenance-focused commercial teams focused on existing patient base retention.
Mechanism of Action
sodium/misoprostol is a combination product containing diclofenac sodium, an NSAID with analgesic, anti-inflammatory and antipyretic properties, and misoprostol, a GI mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac The mechanism of action of diclofenac, like that of other NSAIDs, is…
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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.