Sublingual buprenorphine-naloxone — Competitive Intelligence Brief

Sublingual buprenorphine-naloxone (Sublingual buprenorphine-naloxone) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid partial agonist. Area: Pain.

phase 3 Opioid partial agonist Opioid receptors Pain Small molecule

Target snapshot

Sublingual buprenorphine-naloxone (Sublingual buprenorphine-naloxone) — Yih-Ing Hser. Buprenorphine is a partial opioid agonist that binds to opioid receptors, while naloxone is an opioid antagonist that blocks opioid receptors.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Sublingual buprenorphine-naloxone TARGET	Sublingual buprenorphine-naloxone	Yih-Ing Hser	phase 3	Opioid partial agonist	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
Crushed ticagrelor, morphine,naloxone	Crushed ticagrelor, morphine,naloxone	Collegium Medicum w Bydgoszczy	marketed	Antiplatelet agent + opioid + opioid antagonist combination	P2Y12 receptor (ticagrelor); mu opioid receptor (morphine); opioid receptors (naloxone antagonism)
Naltrexone Pill	Naltrexone Pill	Albert Einstein Healthcare Network	marketed	Opioid receptor antagonist	Opioid receptors (mu, delta, kappa)

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 partial agonist class)

1. Brigham and Women's Hospital · 1 drug in this class
2. Orexo AB · 1 drug in this class
3. Orient Pharma Co., Ltd. · 1 drug in this class
4. Rutgers, The State University of New Jersey · 1 drug in this class
5. Yih-Ing Hser · 1 drug in this class