RYZOLT
LOE ApproachingNDAORALTABLET, EXTENDED RELEASE
Approved
Dec 2008
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
RYZOLT by Purdue Pharma is ). Approved for moderate to moderately severe chronic pain in adults. First approved in 2008.
Drug data last refreshed 2d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RYZOLT is an extended-release oral tablet containing tramadol, a synthetic opioid analgesic that works through dual mechanisms: mu-receptor agonism and monoamine reuptake inhibition. It is indicated for moderate to moderately severe chronic pain in adults. The formulation is a racemate where both tramadol and its active metabolite M1 circulate systemically with dose-proportional pharmacokinetics.
LOE Approaching
As LOE approaches, the brand team will likely shift focus toward lifecycle management, cost optimization, and defensive strategies against generic entry.
Mechanism of Action
). RYZOLT™ is formulated as a racemate and both tramadol and M1 are detected in the circulation. The pharmacokinetics of tramadol and M1 are dose-proportional over a 100 to 300 mg dose range in healthy subjects. ). and ). The total amount of tramadol and M1 removed during a 4-hour dialysis period…
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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.