Subutex, Buprenorphine Hydrochloride, SCH 28444 — Competitive Intelligence Brief

Subutex, Buprenorphine Hydrochloride, SCH 28444 (Subutex, Buprenorphine Hydrochloride, SCH 28444) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Partial mu-opioid receptor agonist. Area: Psychiatry / Addiction Medicine.

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

Target snapshot

Subutex, Buprenorphine Hydrochloride, SCH 28444 (Subutex, Buprenorphine Hydrochloride, SCH 28444) — Indivior Inc.. Buprenorphine is a partial mu-opioid receptor agonist that reduces cravings and withdrawal symptoms in opioid use disorder.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Subutex, Buprenorphine Hydrochloride, SCH 28444 TARGET	Subutex, Buprenorphine Hydrochloride, SCH 28444	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)
Use of buprenorphine with FAO > 30 OME	Use of buprenorphine with FAO > 30 OME	Fox Chase Cancer Center	marketed	Partial mu-opioid receptor agonist	Mu-opioid receptor (μ-OR)
Injectable subcutaneous buprenorphine	Injectable subcutaneous buprenorphine	VA Office of Research and Development	marketed	Partial mu-opioid receptor agonist	Mu-opioid receptor (μ-OR)
Injectable buprenorphine	Injectable buprenorphine	University of California, San Francisco	marketed	Partial mu-opioid receptor agonist	Mu-opioid receptor (OPRM1)
Buprenorphine Buccal Film [Belbuca]	Buprenorphine Buccal Film [Belbuca]	Carolinas Pain Institute	marketed	Partial mu-opioid receptor agonist	Mu-opioid receptor (μ-OR)
Transmucosal Buprenorphine	Transmucosal Buprenorphine	Indivior Inc.	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