hydrocodone / acetaminophen extended release — Competitive Intelligence Brief

hydrocodone / acetaminophen extended release (hydrocodone / acetaminophen extended release) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid agonist / non-opioid analgesic. Area: Pain management.

phase 3 Opioid agonist / non-opioid analgesic Opioid receptors Pain management Small molecule

Target snapshot

hydrocodone / acetaminophen extended release (hydrocodone / acetaminophen extended release) — Abbott. Hydrocodone is an opioid agonist that binds to opioid receptors in the brain, while acetaminophen is a non-opioid analgesic that works by inhibiting the production of prostaglandins.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
hydrocodone / acetaminophen extended release TARGET	hydrocodone / acetaminophen extended release	Abbott	phase 3	Opioid agonist / non-opioid analgesic	Opioid receptors
SAMIDORPHAN L-MALATE	SAMIDORPHAN L-MALATE		marketed	Atypical Antipsychotic [EPC]	dopamine and serotonin type 2 (5HT2) receptors, opioid receptors	2021-01-01
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
NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE		marketed		kappa opioid receptors, mu opioid receptors	1979-01-01
Methadone Hydrochloride	METHADONE	Specgx Llc	marketed	Opioid Agonist	mu-opioid receptors, NMDA receptor	1947-01-01
Zubsolv sublingual tablets	Zubsolv sublingual tablets	Indivior Inc.	marketed	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine); opioid receptors (naloxone antagonism)
oxycodone/APAP	oxycodone/APAP	Albert Einstein College of Medicine	marketed	Opioid analgesic combination	Opioid receptors (mu, delta, kappa); cyclooxygenase enzymes

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 agonist / non-opioid analgesic class)

1. Abbott · 1 drug in this class