nebulized morphine — Competitive Intelligence Brief

nebulized morphine (nebulized morphine) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: opioid. Area: Pain management.

phase 3 opioid mu-opioid receptor Pain management Small molecule

Target snapshot

nebulized morphine (nebulized morphine) — University of Monastir. Nebulized morphine works by releasing morphine into the lungs to provide pain relief.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
nebulized morphine TARGET	nebulized morphine	University of Monastir	phase 3	opioid	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 Hydrochloride	Fresenius Kabi	marketed	Opioid agonist	Mu-opioid receptor	1984-01-01
Dilaudid-Hp	HYDROMORPHONE	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 class)

1. Norwegian University of Science and Technology · 2 drugs in this class
2. Cari Health Inc. · 1 drug in this class
3. Cedars-Sinai Medical Center · 1 drug in this class
4. Depomed · 1 drug in this class
5. Mundipharma Pharmaceuticals B.V. · 1 drug in this class
6. St. Olavs Hospital · 1 drug in this class
7. Talphera, Inc · 1 drug in this class
8. The Hospital for Sick Children · 1 drug in this class
9. University of Monastir · 1 drug in this class
10. University of Sao Paulo · 1 drug in this class