hydrocodone/APAP — Competitive Intelligence Brief

hydrocodone/APAP (hydrocodone/APAP) 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 (hydrocodone); COX inhibitor (acetaminophen) Pain Management Small molecule

Target snapshot

hydrocodone/APAP (hydrocodone/APAP) — VA Office of Research and Development. Hydrocodone is an opioid agonist that binds to mu opioid receptors in the central nervous system to reduce pain, while acetaminophen (APAP) inhibits prostaglandin synthesis to provide additional analgesic and antipyretic effects.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
hydrocodone/APAP TARGET	hydrocodone/APAP	VA Office of Research and Development	marketed	Opioid analgesic combination	Mu opioid receptor (hydrocodone); COX inhibitor (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
Zaldiar®	Zaldiar®	Labopharm Inc.	marketed	Opioid analgesic combination	μ-opioid receptor; norepinephrine and serotonin transporters; COX (paracetamol component)
Hydrocodone-Acetaminophen	Hydrocodone-Acetaminophen	Henry Ford Health System	marketed	Opioid analgesic combination	Mu opioid receptor (hydrocodone); COX inhibitor (acetaminophen)
Codeine paracetamol	Codeine paracetamol	Napp Pharmaceuticals Limited	marketed	Opioid analgesic combination	Opioid receptors (μ, δ, κ); cyclooxygenase (COX-1, COX-2)
hydrocodone plus acetaminophen	hydrocodone plus acetaminophen	University of California, Davis	marketed	Opioid analgesic combination	Mu opioid receptor (hydrocodone); COX inhibitor (acetaminophen)
hydrocodone, acetaminophen and ibuprofen	hydrocodone, acetaminophen and ibuprofen	Albany Medical College	marketed	Opioid analgesic combination	Opioid receptors (hydrocodone); COX-1/COX-2 (ibuprofen); unclear (acetaminophen)

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