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Profile for Tradename: exalgo

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Exalgo is a drug marketed by Mallinckrodt Inc and is included in one NDA. It is available from five suppliers. There are two patents protecting this drug.

This drug has fourteen patent family members in eleven countries.

The generic ingredient in EXALGO is hydromorphone hydrochloride. There are thirteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

Summary for Tradename: exalgo

Patents:2
Applicants:1
NDAs:1
Suppliers: see list5

Pharmacology for Tradename: exalgo

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Clinical Trials for: exalgo

Methadone and Hydromorphone For Spinal Surgery
Status: Recruiting Condition: Hydromorphone Use; Acute Postoperative Pain; Patient Satisfaction; Chronic Persistent Surgical Pain

Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain
Status: Completed Condition: Neuropathic Pain

An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain
Status: Completed Condition: Postoperative Pain

Association Between Body Size and Response to Hydromorphone in ED
Status: Recruiting Condition: Pain

Fixed Dose of Intravenous Hydromorphone in the Treatment of Acute Pain
Status: Completed Condition: Acute Pain

Intrathecal Hydromorphone for Post-cesarean Delivery Pain - a Dose Finding Study
Status: Not yet recruiting Condition: Healthy; Human; Adult; Parturient

Study of Respiratory Depression When Using a Hydromorphone Pain Protocol
Status: Terminated Condition: Pain; Respiratory Depression

Single-arm Study to Assess the Safety of Hydromorphone HCl by Intrathecal Administration
Status: Recruiting Condition: Chronic Pain

Intrathecal Hydromorphone for Pain Control After Cesarean Section
Status: Recruiting Condition: Pain; Cesarean Section

Safety and Efficacy Study of Hydromorphone HCl by Intrathecal Administration Using a Programmable Implantable Pump
Status: Recruiting Condition: Management of Chronic Pain

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-003Mar 1, 2010RXNo5,702,725<disabled>Y<disabled>
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-002Mar 1, 2010RXNo5,702,725<disabled>Y<disabled>
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-001Mar 1, 2010RXNo5,702,725<disabled>Y<disabled>
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-002Mar 1, 2010RXNo5,914,131<disabled>Y<disabled>
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-003Mar 1, 2010RXNo5,914,131<disabled>Y<disabled>
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Non-Orange Book Patents for Tradename: EXALGO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,529,787 Hydromorphone therapy<disabled in preview>
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International Patent Family for Tradename: EXALGO

Country Document Number Publication Date
Australia2908395Feb 09, 1996
Spain2186724May 16, 2003
Austria230992Feb 15, 2003
Portugal1025845Mar 31, 2003
Austria227575Nov 15, 2002
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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