oPLB — Competitive Intelligence Brief

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

phase 3 Partial mu-opioid receptor agonist Mu-opioid receptor Psychiatry / Addiction Medicine Small molecule

Target snapshot

oPLB (oPLB) — National Institute on Drug Abuse (NIDA). oPLB is a long-acting buprenorphine formulation designed to provide sustained opioid agonist therapy for opioid use disorder.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
oPLB TARGET	oPLB	National Institute on Drug Abuse (NIDA)	phase 3	Partial mu-opioid receptor agonist	Mu-opioid receptor
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
Dilaudid-Hp	HYDROMORPHONE	Fresenius Kabi	marketed	Opioid Agonist	mu-opioid receptor	1984-01-01
Dilaudid-Hp	Hydromorphone Hydrochloride	Fresenius Kabi	marketed	Opioid agonist	Mu-opioid receptor	1984-01-01
Subutex	BUPRENORPHINE	Purdue Pharma Lp	marketed	Partial Opioid Agonist	mu-opioid receptor, kappa-opioid receptor	1981-01-01
Subutex	Buprenorphine Hydrochloride	Indivior	marketed	partial opioid agonist	mu-opioid receptor, kappa-opioid receptor	1981-01-01
Levo-Dromoran	LEVORPHANOL	Bausch Health	marketed	Opioid Agonist	mu-opioid receptor	1953-01-01

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)

• 2026-07-31 — Subutex · 8236755 · Formulation · US
• 2027-01-10 — Subutex · 8236292 · Formulation · US
• 2027-07-23 — Subutex · 8147866 · Formulation · US
• 2027-07-23 — Subutex · 9655843 · Formulation · US
• 2031-06-06 — Subutex · 9782402 · Formulation · US
• 2031-06-06 — Subutex · 9827241 · Formulation · US
• 2031-06-06 — Subutex · 10198218 · Method of Use · US
• 2031-06-06 — Subutex · 10592168 · Method of Use · US
• 2031-06-06 — Subutex · 9498432 · Formulation · US
• 2031-06-06 — Subutex · 9272044 · Method of Use · US
• 2031-06-25 — Subutex · 10558394 · Formulation · US
• 2031-09-05 — Subutex · 8975270 · Formulation · US
• 2032-01-06 — Subutex · 8921387 · Formulation · US
• 2032-07-26 — Subutex · 11135215 · Formulation · US
• 2032-07-26 — Subutex · 12318379 · Formulation · US
• 2032-07-26 — Subutex · 12161640 · Formulation · US
• 2032-07-26 — Subutex · 11110084 · Formulation · US
• 2032-07-26 — Subutex · 10912772 · Method of Use · US
• 2032-07-26 — Subutex · 9937164 · Formulation · US
• 2032-12-21 — Subutex · 9901539 · Method of Use · US
• 2035-11-06 — Subutex · 11000520 · Method of Use · US
• 2035-11-06 — Subutex · 11839611 · Method of Use · US
• 2038-06-22 — Subutex · 10646484 · Method of Use · US

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