NDAORALTABLET
Approved
Oct 2021
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
SEGLENTIS (celecoxib; tramadol hydrochloride) by Kowa Pharmaceuticals is 12. First approved in 2021.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEGLENTIS is a fixed-dose combination tablet containing celecoxib (a selective COX-2 inhibitor) and tramadol hydrochloride (an opioid analgesic) for oral use. It works through dual mechanism: celecoxib inhibits prostaglandin synthesis to reduce pain and inflammation, while tramadol provides opioid analgesia. It is indicated for moderate to moderately severe pain in patients requiring both anti-inflammatory and opioid analgesic effects.
$0.664MPart D
Peak5.1 years to LOEProduct in peak phase with modest Medicare utilization; small commercial footprint suggests limited team expansion opportunities.
Mechanism of Action
12. CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Celecoxib has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of celecoxib is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of COX-2. Celecoxib is a potent inhibitor of…
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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.