PCM/Oxy2 — Competitive Intelligence Brief

PCM/Oxy2 (PCM/Oxy2) 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 (oxycodone); COX enzymes (paracetamol) Pain Management Small molecule

Target snapshot

PCM/Oxy2 (PCM/Oxy2) — Maastricht University Medical Center. PCM/Oxy2 is a fixed-dose combination of paracetamol (acetaminophen) and oxycodone that provides analgesia through dual mechanisms: paracetamol's antipyretic and analgesic effects via COX inhibition, and oxycodone's opioid receptor agonism for moderate-to-severe pain relief.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
PCM/Oxy2 TARGET	PCM/Oxy2	Maastricht University Medical Center	marketed	Opioid analgesic combination	Mu opioid receptor (oxycodone); COX enzymes (paracetamol)
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
Bupivacaine and Fentanyl	Bupivacaine and Fentanyl	Bnai Zion Medical Center	marketed	Local anesthetic with opioid analgesic combination	Voltage-gated sodium channels (bupivacaine); mu-opioid receptor (fentanyl)
Motrin and narcotic	Motrin and narcotic	Cape Fear Valley Health System	marketed	NSAID + opioid analgesic combination	COX-1/COX-2 (ibuprofen); mu, delta, and kappa opioid receptors (narcotic component)
Oxycodone/ acetaminophen	Oxycodone/ acetaminophen	Montefiore Medical Center	marketed	Opioid analgesic combination	Mu opioid receptor (oxycodone); COX inhibition (acetaminophen)
bucain + fentanyl	bucain + fentanyl	University of Debrecen	marketed	Local anesthetic + opioid analgesic combination	Voltage-gated sodium channels (bucain); mu-opioid receptor (fentanyl)
Tramadol HCl-Paracetamol	Tramadol HCl-Paracetamol	Xian-Janssen Pharmaceutical Ltd.	marketed	Opioid analgesic combination	Opioid receptors (μ, δ, κ); monoamine transporters (norepinephrine, serotonin); 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 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