APOTEL max — Competitive Intelligence Brief

APOTEL max (APOTEL max) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Analgesic combination. Area: Pain Management.

marketed Analgesic combination Pain Management Small molecule

Target snapshot

APOTEL max (APOTEL max) — Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.. APOTEL max is a fixed-dose combination of paracetamol (acetaminophen) and an additional analgesic or anti-inflammatory agent that works to reduce pain and fever through multiple pathways.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
APOTEL max TARGET	APOTEL max	Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.	marketed	Analgesic combination
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
Codeine with acetaminophen	Codeine with acetaminophen	Children's Hospitals and Clinics of Minnesota	marketed	Opioid analgesic combination	Mu opioid receptor (codeine); COX enzymes (acetaminophen)
Motrin and narcotic	Motrin and narcotic	Cape Fear Valley Health System	marketed	NSAID + opioid analgesic combination	COX-1/COX-2 (ibuprofen); mu, delta, and kappa opioid receptors (narcotic component)
Dexketoprofen Trometamol + Paracetamol	Dexketoprofen Trometamol + Paracetamol	Yuzuncu Yil University	marketed	NSAID + analgesic combination	COX-1, COX-2 (dexketoprofen); central prostaglandin synthesis and pain pathways (paracetamol)
hydroxycontin/acetominophen	hydroxycontin/acetominophen	University of Rochester	marketed	Opioid analgesic combination	Mu-opioid receptor; cyclooxygenase (COX)
hydrocodone/APAP w placebo PRN	hydrocodone/APAP w placebo PRN	VA Office of Research and Development	marketed	Opioid analgesic combination	Mu opioid receptor (hydrocodone); cyclooxygenase enzymes (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 (Analgesic combination class)

1. Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. · 1 drug in this class