Dilaudid-Hp — Competitive Intelligence Brief

Dilaudid-Hp (Hydromorphone Hydrochloride) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid agonist. Area: Neuroscience.

marketed Opioid agonist Mu-opioid receptor Neuroscience Small molecule

Target snapshot

Dilaudid-Hp (Hydromorphone Hydrochloride) — Fresenius Kabi. Full mu-opioid receptor agonist providing analgesia through CNS opioid receptor activation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Dilaudid-Hp TARGET	Hydromorphone Hydrochloride	Fresenius Kabi	marketed	Opioid agonist	Mu-opioid receptor	1984-01-01
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
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
Methadone Hydrochloride	METHADONE	Specgx Llc	marketed	Opioid Agonist	mu-opioid receptors, NMDA receptor	1947-01-01

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 agonist class)

1. University of British Columbia · 3 drugs in this class
2. Ciusss de L'Est de l'Île de Montréal · 2 drugs in this class
3. Kaohsiung Veterans General Hospital. · 2 drugs in this class
4. Nycomed · 2 drugs in this class
5. Rigshospitalet, Denmark · 2 drugs in this class
6. University Hospital, Ghent · 2 drugs in this class
7. Fundación Universitaria de Ciencias de la Salud · 2 drugs in this class
8. Erasme University Hospital · 2 drugs in this class
9. Cephalon · 2 drugs in this class
10. Corporacion Parc Tauli · 1 drug in this class