Who are Oxycodone & naloxone combination, prolonged release's main competitors?

Direct comparators (same drug class / molecular target / therapeutic area): BENZHYDROCODONE, Dilaudid-Hp, Dilaudid-Hp, Subutex, Subutex, Levo-Dromoran.

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Last reviewed 2026-06-10 · How we verify

Oxycodone & naloxone combination, prolonged release — Competitive Intelligence Brief

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

Oxycodone & naloxone combination, prolonged release (Oxycodone & naloxone combination, prolonged release) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: opioid agonist-antagonist. Area: Pain management.

phase 3 opioid agonist-antagonist mu-opioid receptor Pain management Small molecule Live · refreshed every 30 min

Target snapshot

Oxycodone & naloxone combination, prolonged release (Oxycodone & naloxone combination, prolonged release) — Mundipharma Research GmbH & Co KG. Oxycodone is a mu-opioid receptor agonist, while naloxone is a mu-opioid receptor antagonist.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Oxycodone & naloxone combination, prolonged release TARGET	Oxycodone & naloxone combination, prolonged release	Mundipharma Research GmbH & Co KG	phase 3	opioid agonist-antagonist	mu-opioid receptor
BENZHYDROCODONE	BENZHYDROCODONE		marketed	Opioid analgesic combination; full mu-opioid agonist with non-opioid analgesic	Mu-opioid receptors (primary); delta and kappa opioid receptors (secondary); central nervous system pain pathways	2018-01-01
Dilaudid-Hp	HYDROMORPHONE	Fresenius Kabi	marketed	Opioid Agonist	mu-opioid receptor	1984-01-01
Dilaudid-Hp	Hydromorphone Hydrochloride	Fresenius Kabi	marketed	Opioid agonist	Mu-opioid receptor	1984-01-01
Subutex	Buprenorphine Hydrochloride	Indivior	marketed	partial opioid agonist	mu-opioid receptor, kappa-opioid receptor	1981-01-01
Subutex	BUPRENORPHINE	Purdue Pharma Lp	marketed	Partial Opioid Agonist	mu-opioid receptor, kappa-opioid receptor	1981-01-01
Levo-Dromoran	LEVORPHANOL	Bausch Health	marketed	Opioid Agonist	mu-opioid receptor	1953-01-01

Recent regulatory actions (last 90 days)

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

Upcoming PDUFA dates (next 180 days)

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

Patent timeline (forward window)

2026-07-31 — Subutex · 8236755 · Formulation · US
2027-01-10 — Subutex · 8236292 · Formulation · US
2027-07-23 — Subutex · 8147866 · Formulation · US
2027-07-23 — Subutex · 9655843 · Formulation · US
2031-06-06 — Subutex · 9782402 · Formulation · US
2031-06-06 — Subutex · 9827241 · Formulation · US
2031-06-06 — Subutex · 10198218 · Method of Use · US
2031-06-06 — Subutex · 10592168 · Method of Use · US
2031-06-06 — Subutex · 9498432 · Formulation · US
2031-06-06 — Subutex · 9272044 · Method of Use · US
2031-06-25 — Subutex · 10558394 · Formulation · US
2031-09-05 — Subutex · 8975270 · Formulation · US
2032-01-06 — Subutex · 8921387 · Formulation · US
2032-07-26 — Subutex · 11135215 · Formulation · US
2032-07-26 — Subutex · 12318379 · Formulation · US
2032-07-26 — Subutex · 12161640 · Formulation · US
2032-07-26 — Subutex · 11110084 · Formulation · US
2032-07-26 — Subutex · 10912772 · Method of Use · US
2032-07-26 — Subutex · 9937164 · Formulation · US
2032-12-21 — Subutex · 9901539 · Method of Use · US
2035-11-06 — Subutex · 11000520 · Method of Use · US
2035-11-06 — Subutex · 11839611 · Method of Use · US
2038-06-22 — Subutex · 10646484 · Method of Use · US

Sponsor landscape (opioid agonist-antagonist class)

Mundipharma Research GmbH & Co KG · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Oxycodone & naloxone combination, prolonged release — Competitive Intelligence Brief. https://druglandscape.com/ci/oxycodone-naloxone-combination-prolonged-release. Accessed 2026-06-10.

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