NDAORALTABLET, EXTENDED RELEASEPriority Review
Approved
Dec 2011
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
2
Data completeness
4/8 — Partial
Priority Review
OPANA ER (oxymorphone hydrochloride) by Ascentage Pharma is clinical pharmacology oxymorphone is an opioid agonist whose principal therapeutic action is analgesia. First approved in 2011.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OPANA ER (oxymorphone hydrochloride) is an extended-release oral opioid agonist indicated for chronic pain management in opioid-tolerant patients. It works by binding to central and peripheral opioid receptors to produce analgesia, with pharmacological effects including anxiolysis, respiratory depression, and constipation. The drug has no defined maximum dose; analgesic ceiling is determined only by side effects including somnolence and respiratory depression.
LOE Approaching3.2 years to LOE
Product is approaching loss of exclusivity in 3.2 years; brand team likely focused on life-cycle extension strategies and defensive positioning against generic entry.
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…
Worked on OPANA ER at Ascentage Pharma? Share your interview experience or compensation data (+7 days Pro)
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.