Panadeine® Extra — Competitive Intelligence Brief

Panadeine® Extra (Panadeine® Extra) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid analgesic. Area: Pain management.

phase 3 Opioid analgesic Opioid receptors Pain management Small molecule

Target snapshot

Panadeine® Extra (Panadeine® Extra) — Reckitt Benckiser LLC. Panadeine Extra contains paracetamol and codeine, which work together to relieve pain and reduce fever.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Panadeine® Extra TARGET	Panadeine® Extra	Reckitt Benckiser LLC	phase 3	Opioid analgesic	Opioid receptors
SAMIDORPHAN L-MALATE	SAMIDORPHAN L-MALATE		marketed	Atypical Antipsychotic [EPC]	dopamine and serotonin type 2 (5HT2) receptors, opioid receptors	2021-01-01
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
NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE		marketed		kappa opioid receptors, mu opioid receptors	1979-01-01
Methadone Hydrochloride	METHADONE	Specgx Llc	marketed	Opioid Agonist	mu-opioid receptors, NMDA receptor	1947-01-01
Zubsolv sublingual tablets	Zubsolv sublingual tablets	Indivior Inc.	marketed	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine); opioid receptors (naloxone antagonism)
ropivacaine,morphine chloride,epinephrine,ketorolac	ropivacaine,morphine chloride,epinephrine,ketorolac	Jose Antonio Bernia Gil	marketed	Multimodal analgesic combination (local anesthetic + opioid + NSAID + sympathomimetic)	Sodium channels (ropivacaine), mu-opioid receptors (morphine), alpha/beta-adrenergic receptors (epinephrine), cyclooxygenase 1 and 2 (ketorolac)

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 class)

1. Alza Corporation, DE, USA · 3 drugs in this class
2. Labopharm Inc. · 3 drugs in this class
3. University of Rochester · 3 drugs in this class
4. Purdue Pharma LP · 3 drugs in this class
5. Institute of Child Health · 2 drugs in this class
6. London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · 2 drugs in this class
7. Fujian Cancer Hospital · 2 drugs in this class
8. Children's Hospital of Fudan University · 2 drugs in this class
9. AdventHealth · 2 drugs in this class
10. Danish University of Pharmaceutical Sciences · 2 drugs in this class