hydrocodone, acetaminophen and ibuprofen — Competitive Intelligence Brief

hydrocodone, acetaminophen and ibuprofen (hydrocodone, acetaminophen and ibuprofen) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid analgesic combination. Area: Pain Management.

marketed Opioid analgesic combination Opioid receptors (hydrocodone); COX-1/COX-2 (ibuprofen); unclear (acetaminophen) Pain Management Small molecule

Target snapshot

hydrocodone, acetaminophen and ibuprofen (hydrocodone, acetaminophen and ibuprofen) — Albany Medical College. This combination drug provides pain relief through three complementary mechanisms: hydrocodone acts as an opioid agonist, acetaminophen inhibits prostaglandin synthesis, and ibuprofen inhibits cyclooxygenase enzymes.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
hydrocodone, acetaminophen and ibuprofen TARGET	hydrocodone, acetaminophen and ibuprofen	Albany Medical College	marketed	Opioid analgesic combination	Opioid receptors (hydrocodone); COX-1/COX-2 (ibuprofen); unclear (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
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)
hydrocodone/APAP	hydrocodone/APAP	VA Office of Research and Development	marketed	Opioid analgesic combination	Mu opioid receptor (hydrocodone); COX inhibitor (acetaminophen)
Ultracet®	Ultracet®	Labopharm Inc.	marketed	Opioid analgesic combination	Mu-opioid receptor; norepinephrine and serotonin transporters; COX enzymes
Tramadol /acetaminophen	Tramadol /acetaminophen	Johnson & Johnson Taiwan Ltd	marketed	Opioid analgesic combination	Mu opioid receptor; norepinephrine transporter; serotonin transporter; cyclooxygenase
Tramadol hydrochloride/ Acetaminophen	Tramadol hydrochloride/ Acetaminophen	Janssen Korea, Ltd., Korea	marketed	Opioid analgesic combination	Mu-opioid receptor; norepinephrine transporter; serotonin transporter

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