Comparator: oxycodone and acetaminophen — Competitive Intelligence Brief

Comparator: oxycodone and acetaminophen (Comparator: oxycodone and acetaminophen) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid analgesic combination. Area: Pain Management.

phase 3 Opioid analgesic combination Mu-opioid receptor (oxycodone); COX inhibition and TRPV1 modulation (acetaminophen) Pain Management Small molecule

Target snapshot

Comparator: oxycodone and acetaminophen (Comparator: oxycodone and acetaminophen) — Merck Sharp & Dohme LLC. This is a fixed-dose combination of oxycodone (a mu-opioid receptor agonist) and acetaminophen (a non-opioid analgesic) that provides pain relief through dual mechanisms.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Comparator: oxycodone and acetaminophen TARGET	Comparator: oxycodone and acetaminophen	Merck Sharp & Dohme LLC	phase 3	Opioid analgesic combination	Mu-opioid receptor (oxycodone); COX inhibition and TRPV1 modulation (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
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)
Oxycodone and acetaminophen	Oxycodone and acetaminophen	University of Puerto Rico	marketed	Opioid analgesic combination	Mu opioid receptor (oxycodone); cyclooxygenase enzymes (acetaminophen)
Oxycontin/acetominophen	Oxycontin/acetominophen	University of Rochester	marketed	Opioid analgesic combination	Mu opioid receptor (oxycodone); COX inhibitor (acetaminophen)
PCM/Oxy2	PCM/Oxy2	Maastricht University Medical Center	marketed	Opioid analgesic combination	Mu opioid receptor (oxycodone); COX enzymes (paracetamol)
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)

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