Codeine/acetaminophen — Competitive Intelligence Brief

Codeine/acetaminophen (Codeine/acetaminophen) 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

Codeine/acetaminophen (Codeine/acetaminophen) — Montefiore Medical Center. Codeine is converted to morphine in the body to activate opioid receptors for pain relief, while acetaminophen inhibits prostaglandin synthesis to reduce pain and fever.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Codeine/acetaminophen TARGET	Codeine/acetaminophen	Montefiore Medical Center	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
Acetaminophen/Codeine	Acetaminophen/Codeine	University of Pennsylvania	marketed	Opioid analgesic combination	Mu opioid receptor (codeine); COX enzymes (acetaminophen)
Ropivacaine + Tramadol	Ropivacaine + Tramadol	Aga Khan University	marketed	Local anesthetic + opioid analgesic combination	Voltage-gated sodium channels (ropivacaine); mu-opioid receptor, norepinephrine transporter, serotonin transporter (tramadol)
PCM/Oxy2	PCM/Oxy2	Maastricht University Medical Center	marketed	Opioid analgesic combination	Mu opioid receptor (oxycodone); COX enzymes (paracetamol)
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)
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