OPANA ER

Peak

oxymorphone hydrochloride

NDAORALTABLET, EXTENDED RELEASE
Approved
Jun 2006
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
2

Clinical Trials (2)

NCT00857142Phase 1Completed

Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fed Conditions

Started Nov 2007
32 enrolled
Pain
NCT00857428Phase 1Completed

Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted Conditions

Started Nov 2007
50 enrolled
Pain

Loss of Exclusivity

LOE Date
Nov 22, 2029
45 months away
Patent Expiry
Nov 22, 2029

Patent Records (2)

Patent #ExpiryTypeUse Code
8808737
Jun 21, 2027
U-3085
8871779
Nov 22, 2029
Substance
—
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers