OXY/APAP — Competitive Intelligence Brief

OXY/APAP (OXY/APAP) 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 monoamine modulation (acetaminophen) Pain Management Small molecule

Target snapshot

OXY/APAP (OXY/APAP) — Purdue Pharma LP. OXY/APAP combines oxycodone (an opioid analgesic) with acetaminophen (a non-opioid analgesic) to provide enhanced pain relief through dual mechanisms.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
OXY/APAP TARGET	OXY/APAP	Purdue Pharma LP	phase 3	Opioid analgesic combination	Mu opioid receptor (oxycodone); COX inhibition and monoamine 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
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)
Morphine-Promethazine	Morphine-Promethazine	Tel-Aviv Sourasky Medical Center	marketed	Opioid analgesic combination	Mu-opioid receptor (morphine); H1 histamine receptor (promethazine)
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)
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
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