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List of Extended-Release and Long-Acting Opioid Products Required to Have an Opioid REMS

This information is no longer current.
Please see List of Application Numbers and Sponsors (PDF- 57KB) for current information.

Brand Name Products


Trade Name

Generic NameSponsor
1AvinzaMorphine sulfate extended-release capsulesPfizer
2ButransBuprenorphine transdermal systemPurdue Pharma
3DolophineMethadone hydrochloride tabletsRoxane
4DuragesicFentanyl transdermal systemJanssen Pharmaceuticals
5**EmbedaMorphine sulfate and naltrexone extended-release capsulesPfizer
6ExalgoHydromorphone hydrochloride extended-release tabletsMallinckrodt
7Kadian Morphine sulfate extended-release capsulesActavis
8MS ContinMorphine sulfate controlled-release tabletsPurdue Pharma
9Nucynta ERTapentadol extended-release oral tabletsJanssen Pharmaceuticals
10Opana EROxymorphone hydrochloride extended-release tabletsEndo Pharmaceuticals
11OxyContinOxycodone hydrochloride controlled-release tabletsPurdue Pharma
12*PalladoneHydromorphone hydrochloride extended-release capsulesPurdue Pharma

*No longer being marketed, but is still approved.
**Not currently available or marketed due to a voluntary recall, but is still approved.

Generic Products

 Drug NameGeneric NameSponsor
1FentanylFentanyl extended-release transdermal systemActavis
2FentanylFentanyl extended-release transdermal systemLavipharm Labs
3FentanylFentanyl extended-release transdermal systemMallinckrodt
4FentanylFentanyl extended-release transdermal systemMylan Technologies
5FentanylFentanyl extended-release transdermal systemNoven
6FentanylFentanyl extended-release transdermal systemAveva
7FentanylFentanyl extended-release transdermal systemWatson
8Methadone HydrochlorideMethadone hydrochloride concentrateRoxane
9Methadone HydrochlorideMethadone hydrochloride tabletsThe Pharmanetwork
10Methadone HydrochlorideMethadone hydrochloride tabletsMallinckrodt
11Methadone HydrochlorideMethadone hydrochloride tabletsSandoz
12Methadone HydrochlorideMethadone hydrochloride oral solutionRoxane
13Methadone HydrochlorideMethadone hydrochloride oral solutionVistapharm
14Morphine SulfateMorphine sulfate extended-release capsulesWatson
15Morphine SulfateMorphine sulfate extended-release tabletsEndo
16Morphine SulfateMorphine sulfate extended-release tabletsMallinckrodt
17Morphine SulfateMorphine sulfate extended-release tabletsMylan
18Morphine SulfateMorphine sulfate extended-release tabletsNesher
19Morphine SulfateMorphine sulfate extended-release tabletsRanbaxy
20Morphine SulfateMorphine sulfate extended-release tabletsRhodes
21Morphine SulfateMorphine sulfate extended-release tabletsWatson Labs
22Oxymorphone HydrochlorideOxymorphone hydrochloride extended-release tabletsImpax
23Oxymorphone HydrochlorideOxymorphone hydrochloride extended-release tabletsActavis

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