Tramadol HCl-Paracetamol — Competitive Intelligence Brief

Tramadol HCl-Paracetamol (Tramadol HCl-Paracetamol) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid analgesic combination. Area: Pain Management.

marketed Opioid analgesic combination Opioid receptors (μ, δ, κ); monoamine transporters (norepinephrine, serotonin); cyclooxygenase enzymes Pain Management Small molecule

Target snapshot

Tramadol HCl-Paracetamol (Tramadol HCl-Paracetamol) — Xian-Janssen Pharmaceutical Ltd.. This combination drug reduces pain through dual action: tramadol inhibits monoamine reuptake and activates opioid receptors, while paracetamol inhibits prostaglandin synthesis.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Tramadol HCl-Paracetamol TARGET	Tramadol HCl-Paracetamol	Xian-Janssen Pharmaceutical Ltd.	marketed	Opioid analgesic combination	Opioid receptors (μ, δ, κ); monoamine transporters (norepinephrine, serotonin); cyclooxygenase enzymes
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
PCM/Oxy1	PCM/Oxy1	Maastricht University Medical Center	marketed	Opioid analgesic combination	Mu opioid receptor (oxycodone); COX enzymes (paracetamol)
Bupivacaine-fentanyl elective group	Bupivacaine-fentanyl elective group	Conrad Arnfinn Bjørshol	marketed	Local anesthetic with opioid analgesic combination	Voltage-gated sodium channels (bupivacaine); 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)
Nalbuphine and morphine	Nalbuphine and morphine	National Taiwan University Hospital	marketed	Opioid analgesic combination	Opioid receptors (mu, kappa, delta)
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