Oxycodone/Naltrexone Capsules — Competitive Intelligence Brief

Oxycodone/Naltrexone Capsules (Oxycodone/Naltrexone Capsules) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: opioid analgesic with abuse-deterrent properties. Area: Pain Management.

phase 3 opioid analgesic with abuse-deterrent properties mu-opioid receptors Pain Management Small molecule

Target snapshot

Oxycodone/Naltrexone Capsules (Oxycodone/Naltrexone Capsules) — Elite Laboratories, Inc. Oxycodone/Naltrexone capsules combine an opioid analgesic with an opioid antagonist to provide pain relief while reducing the risk of misuse and dependence.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Oxycodone/Naltrexone Capsules TARGET	Oxycodone/Naltrexone Capsules	Elite Laboratories, Inc	phase 3	opioid analgesic with abuse-deterrent properties	mu-opioid receptors
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
Methadone Hydrochloride	METHADONE	Specgx Llc	marketed	Opioid Agonist	mu-opioid receptors, NMDA receptor	1947-01-01
ropivacaine,morphine chloride,epinephrine,ketorolac	ropivacaine,morphine chloride,epinephrine,ketorolac	Jose Antonio Bernia Gil	marketed	Multimodal analgesic combination (local anesthetic + opioid + NSAID + sympathomimetic)	Sodium channels (ropivacaine), mu-opioid receptors (morphine), alpha/beta-adrenergic receptors (epinephrine), cyclooxygenase 1 and 2 (ketorolac)
sevoflurane-sufentanil balanced	sevoflurane-sufentanil balanced	Konkuk University Medical Center	marketed	Balanced anesthetic combination	GABA receptors (sevoflurane); mu-opioid receptors (sufentanil)
Rifaximin and loperamide	Rifaximin and loperamide	The University of Texas Health Science Center, Houston	marketed	Antibiotic + antidiarrheal combination	Bacterial RNA polymerase (rifaximin); mu-opioid receptors in the GI tract (loperamide)
Hyperbaric bupivacaine+Sufentanil	Hyperbaric bupivacaine+Sufentanil	Fundación Pública Andaluza Progreso y Salud	marketed	Local anesthetic + opioid combination	Voltage-gated sodium channels (bupivacaine); mu-opioid receptors (sufentanil)

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)

No upcoming patent expiries for this set.

Sponsor landscape (opioid analgesic with abuse-deterrent properties class)

1. Elite Laboratories, Inc · 1 drug in this class