Acetaminophen/Codeine — Competitive Intelligence Brief

Acetaminophen/Codeine (Acetaminophen/Codeine) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid analgesic combination. Area: Pain Management.

marketed Opioid analgesic combination Mu opioid receptor (codeine); COX enzymes (acetaminophen) Pain Management Small molecule

Target snapshot

Acetaminophen/Codeine (Acetaminophen/Codeine) — University of Pennsylvania. Acetaminophen reduces fever and pain through central nervous system effects, while codeine is an opioid that binds to opioid receptors to provide additional analgesic and antitussive effects.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Acetaminophen/Codeine TARGET	Acetaminophen/Codeine	University of Pennsylvania	marketed	Opioid analgesic combination	Mu opioid receptor (codeine); COX enzymes (acetaminophen)
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
Ropivacaine/Fentanyl	Ropivacaine/Fentanyl	National Institute for Tuberculosis and Lung Diseases, Poland	marketed	Local anesthetic with opioid analgesic combination	Voltage-gated sodium channels (ropivacaine); mu opioid receptor (fentanyl)
metoprolol plus morphine	metoprolol plus morphine	Sahlgrenska University Hospital	marketed	Beta-blocker plus opioid analgesic combination	Beta-1 adrenergic receptor; mu-opioid receptor
dexketoprofen trometamol + tramadol hydrochloride	dexketoprofen trometamol + tramadol hydrochloride	Kavaklıdere Umut Hospital	marketed	NSAID + opioid analgesic combination	COX-1/COX-2 (dexketoprofen); mu-opioid receptor, norepinephrine transporter, serotonin transporter (tramadol)
Ultracet®	Ultracet®	Labopharm Inc.	marketed	Opioid analgesic combination	Mu-opioid receptor; norepinephrine and serotonin transporters; COX enzymes
Standard opioid plus methocarbamol	Standard opioid plus methocarbamol	Prisma Health-Upstate	marketed	Opioid analgesic combination with skeletal muscle relaxant	Mu-opioid receptor (opioid component); central nervous system polysynaptic pathways (methocarbamol component)

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 combination class)

1. VA Office of Research and Development · 3 drugs in this class
2. Rothman Institute Orthopaedics · 2 drugs in this class
3. Labopharm Inc. · 2 drugs in this class
4. University of Rochester · 2 drugs in this class
5. Montefiore Medical Center · 2 drugs in this class
6. Maastricht University Medical Center · 2 drugs in this class
7. Henry Ford Health System · 1 drug in this class
8. Daewon Pharmaceutical Co., Ltd. · 1 drug in this class
9. Albert Einstein College of Medicine · 1 drug in this class
10. Johnson & Johnson Taiwan Ltd · 1 drug in this class