NDAORALTABLET, EXTENDED RELEASE
Approved
Jun 2006
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
2
Data completeness
5/8 — Partial
OPANA ER (oxymorphone hydrochloride) by Ascentage Pharma is clinical pharmacology oxymorphone is an opioid agonist whose principal therapeutic action is analgesia. Approved for pain. First approved in 2006.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OPANA ER is an extended-release oral tablet containing oxymorphone hydrochloride, a pure opioid agonist indicated for moderate to severe pain management. It works by binding to opioid receptors in the central and peripheral nervous system to produce analgesia, with no ceiling effect on pain relief at higher doses. The drug's analgesic action is mediated through CNS opioid receptors in the brain and spinal cord.
Peak3.6 years to LOE
Product is at peak commercial maturity with 3.6 years of patent protection remaining; commercial teams are likely focused on defending market share against generic entry and managing opioid-related reputational challenges.
Mechanism of Action
CLINICAL PHARMACOLOGY Oxymorphone is an opioid agonist whose principal therapeutic action is analgesia. Other members of the class known as opioid agonists include substances such as morphine, oxycodone, hydromorphone, fentanyl, codeine, hydrocodone, and tramadol. In addition to analgesia, other…
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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.