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Last reviewed 2026-06-11 · How we verify

Severe Pain with Opioid Tolerance — Treatment Landscape & Competitive Intelligence

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Severe Pain with Opioid Tolerance (disease) competitive landscape: 4 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

4 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating Severe Pain with Opioid Tolerance, deduplicated by molecule. See the full disease page for line-of-therapy detail.

Drug	Generic	Sponsor	Class	Target	First approval
Dilaudid-Hp	HYDROMORPHONE	Fresenius Kabi	Opioid Agonist	mu-opioid receptor	1984-01-01
Dilaudid-Hp	Hydromorphone Hydrochloride	Fresenius Kabi	Opioid agonist	Mu-opioid receptor	1984-01-01
Opana Er	OXYMORPHONE	Endo	Opioid Agonist	Mu-type opioid receptor	1959-01-01
Naltrexon	Naltrexon	Institute of Liver and Biliary Sciences, India		Neuronal acetylcholine receptor subunit alpha-7, Cytochrome P450 2D6, Delta-type opioid receptor

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this treatment set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

Fresenius Kabi · 2 drugs in Severe Pain with Opioid Tolerance
Endo · 1 drug in Severe Pain with Opioid Tolerance
Institute of Liver and Biliary Sciences, India · 1 drug in Severe Pain with Opioid Tolerance

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Every new regulatory action, PDUFA date, or trial completion in Severe Pain with Opioid Tolerance:

Cite this brief

Drug Landscape (2026). Severe Pain with Opioid Tolerance — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/severe-pain-with-opioid-tolerance. Accessed 2026-06-11.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing