pre-implementation baseline including opioid — Competitive Intelligence Brief

pre-implementation baseline including opioid (pre-implementation baseline including opioid) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid partial agonist. Area: Addiction.

phase 3 Opioid partial agonist mu-opioid receptor Addiction Small molecule

Target snapshot

pre-implementation baseline including opioid (pre-implementation baseline including opioid) — Brigham and Women's Hospital. Buprenorphine is a partial opioid agonist that works by activating opioid receptors in the brain, reducing the craving for opioids and alleviating withdrawal symptoms.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
pre-implementation baseline including opioid TARGET	pre-implementation baseline including opioid	Brigham and Women's Hospital	phase 3	Opioid partial 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 Hydrochloride	Indivior	marketed	partial opioid agonist	mu-opioid receptor, kappa-opioid receptor	1981-01-01
Subutex	BUPRENORPHINE	Purdue Pharma Lp	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 (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