Tramadol hydrochloride/ Acetaminophen — Competitive Intelligence Brief

Tramadol hydrochloride/ Acetaminophen (Tramadol hydrochloride/ 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; norepinephrine transporter; serotonin transporter Pain Management Small molecule

Target snapshot

Tramadol hydrochloride/ Acetaminophen (Tramadol hydrochloride/ Acetaminophen) — Janssen Korea, Ltd., Korea. Tramadol inhibits norepinephrine and serotonin reuptake while acting as a weak opioid agonist, and acetaminophen reduces pain through central analgesic and antipyretic effects.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Tramadol hydrochloride/ Acetaminophen TARGET	Tramadol hydrochloride/ Acetaminophen	Janssen Korea, Ltd., Korea	marketed	Opioid analgesic combination	Mu-opioid receptor; norepinephrine transporter; serotonin transporter
placebo and tramadol	placebo and tramadol	University of Southern Denmark	marketed	Opioid analgesic with monoamine reuptake inhibition	Mu-opioid receptor; norepinephrine transporter; serotonin transporter
Tramadol HCl/acetaminophen Extended Release	Tramadol HCl/acetaminophen Extended Release	Janssen Korea, Ltd., Korea	marketed	Opioid analgesic combination with NSAID alternative	Mu-opioid receptor; norepinephrine transporter; serotonin transporter
Tramadol hydrochloride/Acetaminophen Tab.	Tramadol hydrochloride/Acetaminophen Tab.	Daewon Pharmaceutical Co., Ltd.	phase 3	Opioid analgesic combination	Mu-opioid receptor; norepinephrine transporter; serotonin transporter
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
Tylenol with codeine	Tylenol with codeine	National Center for Complementary and Integrative Health (NCCIH)	marketed	Opioid analgesic combination	Mu opioid receptor (codeine); cyclooxygenase enzymes (acetaminophen)
Morphine-Promethazine	Morphine-Promethazine	Tel-Aviv Sourasky Medical Center	marketed	Opioid analgesic combination	Mu-opioid receptor (morphine); H1 histamine receptor (promethazine)

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