Opana

(Oxymorphone)

PreclinicalSmall molecule

Endo Pharmaceuticals

Opana is one of 59 small molecule programs targeting Nausea and vomiting. It is currently in Preclinical.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Nausea and VomitingActive, not recruiting

Pilot StudyCompleted

Nausea and VomitingPreclinical

Active, not recruiting

Pilot StudyPreclinical

Completed

Competition

Competitive Landscape

78 competitors in Nausea and Vomiting

#DrugCompanyPhaseTrials

Reglan

IIstituto Clinico Humanitas

Approved

13 2

Zithromax

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

1 3

Duragesic

CCephalon

Approved

1 4

Xylocaine

MMEDRx USA, Inc.

Approved

1 5

Thalomid

Bristol-Myers Squibb

Phase 3

2 6

Megace

Bristol-Myers Squibb

Phase 3

1 7

Abraxane

Bristol-Myers Squibb

Phase 3

1 8

Gemzar

Johnson & Johnson

Phase 3

1 9

Nereus

VVanda Pharmaceuticals

Phase 3

2 10

HSK21542

Haisco Pharmaceutical Group Co., Ltd.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Efficacy and Safety3 trials

Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Non-Malignant Pain

Completed· Endo Pharmaceuticals logo

Endo Pharmaceuticals·Phase 3·NCT00226421·120 enrolled

Efficacy and Safety of Oxmorphone Extended Release in Chronic Non-malignant Pain

Completed· Endo Pharmaceuticals logo

Endo Pharmaceuticals·Phase 3·NCT00225797·160 enrolled

Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain

Completed· Endo Pharmaceuticals logo

Endo Pharmaceuticals·Phase 3·NCT00226395·320 enrolled

TED2 trials

Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions

Completed·RRoxane Laboratories·Phase 1·NCT01210638·42 enrolled

Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted Conditions

Completed· Novartis logo

Novartis·Phase 1·NCT00857428·50 enrolled

Chronic pain1 trial

Oxymorphone Extended Release (ER) in Opioid-Naive Patients With Chronic Pain

Completed· Endo Pharmaceuticals logo

Endo Pharmaceuticals·Phase 3·NCT00911287·129 enrolled

Neuropathic Pain1 trial

Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain

Completed· Endo Pharmaceuticals logo

Endo Pharmaceuticals·Phase 3·NCT00911261·223 enrolled

Nausea and vomiting1 trial

Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis

Completed·VVanderbilt University·N/A·NCT02625181·27,034 enrolled

2 more indications

Pilot Study1 trial

A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)

Completed·IIcahn School of Medicine at Mount Sinai·N/A·NCT00580294·12 enrolled

Cancer1 trial

Levorphanol as a Second Line Opioid in Reducing Pain in Patients With Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT03579446·43 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

OPANA

NDA NDA011707

Jan 1, 1982

NUMORPHAN

NDA NDA011738

Jun 22, 2006

OPANA ER

NDA NDA021610

Jun 22, 2006

OPANA

NDA NDA021611

Dec 9, 2011

OPANA ER

NDA NDA201655

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Oxymorphone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Oxymorphone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Oxymorphone. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA201655). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Opana. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Endo Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Preclinical[1]
Company: Endo Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Jun 21, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8808737Jun 21, 2027

7851482Jul 10, 2029

8871779Nov 22, 2029

Opana

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Efficacy and Safety3 trials

TED2 trials

Chronic pain1 trial

Neuropathic Pain1 trial

Nausea and vomiting1 trial

Pilot Study1 trial

Cancer1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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