Immediate Release Sublingual Buprenorphine — Competitive Intelligence Brief

Immediate Release Sublingual Buprenorphine (Immediate Release Sublingual Buprenorphine) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Partial mu-opioid receptor agonist. Area: Addiction Medicine / Pain Management.

marketed Partial mu-opioid receptor agonist Mu-opioid receptor (μ-OR) Addiction Medicine / Pain Management Small molecule

Target snapshot

Immediate Release Sublingual Buprenorphine (Immediate Release Sublingual Buprenorphine) — Royal Victoria Hospital, Canada. Buprenorphine is a partial mu-opioid receptor agonist that binds with high affinity to reduce opioid cravings and withdrawal symptoms while producing a ceiling effect on respiratory depression.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Immediate Release Sublingual Buprenorphine TARGET	Immediate Release Sublingual Buprenorphine	Royal Victoria Hospital, Canada	marketed	Partial mu-opioid receptor agonist	Mu-opioid receptor (μ-OR)
TM buprenorphine	TM buprenorphine	Indivior Inc.	marketed	Partial mu-opioid receptor agonist	Mu-opioid receptor (OPRM1)
Subutex (SCH 028444)	Subutex (SCH 028444)	Merck Sharp & Dohme LLC	marketed	Partial mu-opioid receptor agonist	Mu-opioid receptor (OPRM1)
Transmucosal Buprenorphine	Transmucosal Buprenorphine	Indivior Inc.	marketed	Partial mu-opioid receptor agonist	Mu-opioid receptor (μ-OR)
Buprenorphine SL	Buprenorphine SL	New York State Psychiatric Institute	marketed	Partial mu-opioid receptor agonist	Mu-opioid receptor (μ-OR)
Buprenorphine Buccal Film [Belbuca]	Buprenorphine Buccal Film [Belbuca]	Carolinas Pain Institute	marketed	Partial mu-opioid receptor agonist	Mu-opioid receptor (μ-OR)
Sublingual Buprenorphine (SLB)	Sublingual Buprenorphine (SLB)	NYU Langone Health	marketed	Partial mu-opioid receptor agonist	Mu-opioid receptor (μ-OR)

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 (Partial mu-opioid receptor agonist class)

1. Indivior Inc. · 3 drugs in this class
2. New York State Psychiatric Institute · 3 drugs in this class
3. Orexo AB · 2 drugs in this class
4. BioDelivery Sciences International · 2 drugs in this class
5. King's College London · 1 drug in this class
6. Merck Sharp & Dohme LLC · 1 drug in this class
7. Mundipharma (China) Pharmaceutical Co. Ltd · 1 drug in this class
8. NYU Langone Health · 1 drug in this class
9. National Institute on Drug Abuse (NIDA) · 1 drug in this class
10. Purdue Pharma LP · 1 drug in this class