NDAORALTABLET, EXTENDED RELEASEPriority Review
Approved
Dec 2011
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
2
Data completeness
5/8 — Partial
Priority Review
OPANA ER (oxymorphone hydrochloride) by Ascentage Pharma is clinical pharmacology oxymorphone is an opioid agonist whose principal therapeutic action is analgesia. Approved for pain. First approved in 2011.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OPANA ER (oxymorphone hydrochloride) is an extended-release oral opioid agonist indicated for moderate-to-severe pain management. It works by binding to opioid receptors in the central nervous system to produce analgesia, with no defined maximum dose ceiling—effectiveness is limited only by side effects such as respiratory depression and somnolence.
Peak3.6 years to LOE
Product is in peak commercial lifecycle with moderate competitive pressure (8/10), suggesting stable but defending market position requiring focused brand defense and compliance efforts.
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.