OROS hydromorphone HCL ; Morphine sulfate — Competitive Intelligence Brief

OROS hydromorphone HCL ; Morphine sulfate (OROS hydromorphone HCL ; Morphine sulfate) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid analgesic. Area: Pain Management.

phase 3 Opioid analgesic Mu opioid receptor Pain Management Small molecule

Target snapshot

OROS hydromorphone HCL ; Morphine sulfate (OROS hydromorphone HCL ; Morphine sulfate) — Alza Corporation, DE, USA. OROS hydromorphone HCl is an extended-release opioid agonist that binds to mu opioid receptors in the central nervous system to provide prolonged pain relief.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
OROS hydromorphone HCL ; Morphine sulfate TARGET	OROS hydromorphone HCL ; Morphine sulfate	Alza Corporation, DE, USA	phase 3	Opioid analgesic	Mu opioid receptor
NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE		marketed		kappa opioid receptors, mu opioid receptors	1979-01-01
Hyperbaric bupivacaine+Morphine	Hyperbaric bupivacaine+Morphine	Fundación Pública Andaluza Progreso y Salud	marketed	Local anesthetic + opioid combination	Voltage-gated sodium channels (bupivacaine); mu opioid receptors (morphine)
hydrocodone/APAP w placebo PRN	hydrocodone/APAP w placebo PRN	VA Office of Research and Development	marketed	Opioid analgesic combination	Mu opioid receptor (hydrocodone); cyclooxygenase enzymes (acetaminophen)
Bupivacaine-fentanyl elective group	Bupivacaine-fentanyl elective group	Conrad Arnfinn Bjørshol	marketed	Local anesthetic with opioid analgesic combination	Voltage-gated sodium channels (bupivacaine); mu opioid receptor (fentanyl)
Ibuprofen + Paracetamol + Codeine	Ibuprofen + Paracetamol + Codeine	Ullevaal University Hospital	marketed	Combination analgesic (NSAID + acetaminophen + opioid)	COX-1/COX-2 (ibuprofen, paracetamol); mu opioid receptor (codeine)
Ropivacaine/Fentanyl	Ropivacaine/Fentanyl	National Institute for Tuberculosis and Lung Diseases, Poland	marketed	Local anesthetic with opioid analgesic combination	Voltage-gated sodium channels (ropivacaine); mu opioid receptor (fentanyl)

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 (Opioid analgesic class)

1. Alza Corporation, DE, USA · 3 drugs in this class
2. Labopharm Inc. · 3 drugs in this class
3. University of Rochester · 3 drugs in this class
4. Purdue Pharma LP · 3 drugs in this class
5. Institute of Child Health · 2 drugs in this class
6. London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · 2 drugs in this class
7. Fujian Cancer Hospital · 2 drugs in this class
8. Children's Hospital of Fudan University · 2 drugs in this class
9. AdventHealth · 2 drugs in this class
10. Danish University of Pharmaceutical Sciences · 2 drugs in this class