PCM/Oxy1 — Competitive Intelligence Brief

PCM/Oxy1 (PCM/Oxy1) 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/Oxy1 (PCM/Oxy1) — Maastricht University Medical Center. PCM/Oxy1 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/Oxy1 TARGET	PCM/Oxy1	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
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)
bucain + fentanyl	bucain + fentanyl	University of Debrecen	marketed	Local anesthetic + opioid analgesic combination	Voltage-gated sodium channels (bucain); mu-opioid receptor (fentanyl)
hydrocodone/APAP	hydrocodone/APAP	VA Office of Research and Development	marketed	Opioid analgesic combination	Mu opioid receptor (hydrocodone); COX inhibitor (acetaminophen)
Oxycodone/ acetaminophen	Oxycodone/ acetaminophen	Montefiore Medical Center	marketed	Opioid analgesic combination	Mu opioid receptor (oxycodone); COX inhibition (acetaminophen)
Naproxen Sodium + Codeine Phosphate	Naproxen Sodium + Codeine Phosphate	ibrahim doğru	marketed	NSAID + opioid analgesic combination	COX-1, COX-2, mu-opioid receptor

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