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Profile for Tradename: RYZOLT

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Ryzolt is a drug marketed by Purdue Pharma and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eigthy patent family members in twenty-nine countries.

The generic ingredient in RYZOLT is tramadol hydrochloride. There are thirty-five drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

Summary for Tradename: RYZOLT

Patents:2
Applicants:1
NDAs:1
Suppliers: see list2

Pharmacology for Tradename: RYZOLT

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Clinical Trials for: RYZOLT

Postoperative Tramadol/Gabapentin/Ibuprofen Versus Tramadol/Placebo/Ibuprofen
Status: Recruiting Condition: Pain

A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy
Status: Completed Condition: Tonsillitis; Pain

The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects
Status: Completed Condition: Healthy

A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers
Status: Completed Condition: Healthy

Influence of Diabetes on Tramadol Pharmacokinetics
Status: Completed Condition: Neuropathic Pain; Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

PK PD of the Enantiomers of Tramadol and O-desmethyltramadol in Elderly and Young Subjects
Status: Completed Condition: Aging; Pain

Evaluation of the Role of Tramadol 50mg as an Analgesic During Outpatient Hysteroscopy
Status: Completed Condition: Pain

A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol HCl / Contramid® Tablets to Twice Daily Tramadol HCl (SR) for the Treatment of Osteoarthritis of the Knee
Status: Completed Condition: Osteoarthritis, Knee; Pain

A Study of ULTRAM ER at Two Dose Levels in Adolescents With Pain
Status: Completed Condition: Pain

A Pharmacodynamic/Pharmacokinetic Study to Determine the Onset of Analgesic Effect and Plasma Levels of Tramadol in Patients With Acute Low Back Pain Receiving a Single 200 mg Dose of Tramadol Contramid® Once-a-Day
Status: Completed Condition: Acute Low Back Pain

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-001Dec 30, 2008DISCNNo7,988,998<disabled>Y<disabled>
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-002Dec 30, 2008DISCNNo6,607,748<disabled>Y<disabled>
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-001Dec 30, 2008DISCNNo6,607,748<disabled>Y<disabled>
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-002Dec 30, 2008DISCNNo7,988,998<disabled>Y<disabled>
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-003Dec 30, 2008DISCNNo7,988,998<disabled>Y<disabled>
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Paragraph IV activity for: RYZOLT

Drugname Dosage Strength RLD Submissiondate
tramadol hydrochlorideExtended-release Tablets100 mg, 200 mg and 300 mgRyzolt6/18/2009

Non-Orange Book Patents for Tradename: RYZOLT

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
8,487,002Controlled-release compositions<disabled in preview>
2,009,047,345<disabled in preview>
2,010,151,022<disabled in preview>
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International Patent Family for Tradename: RYZOLT

Country Document Number Publication Date
Canada2414349Jan 10, 2002
Japan4897930Mar 14, 2012
New Zealand539869Sep 28, 2007
Japan2006507276Mar 02, 2006
Russian Federation2274443Apr 20, 2006
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2015 thinkBiotech LLC
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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