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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-two suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

Summary for Tradename: RYZOLT

Suppliers / Packagers: see list10

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

CYTRAM (Cytochrome P450, Tramadol)
Status: Completed Condition: Post-operative Patients Treated by Tramadol

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

A Pharmacokinetic, Tolerability, and Safety Study of ULTRAM ER in Children With Pain
Status: Completed Condition: Pain

Courtesy of
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
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-001Dec 30, 2008DISCNNo7,988,998<disabled>Y <disabled>
Purdue Pharma
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-002Dec 30, 2008DISCNNo6,607,748<disabled>Y <disabled>
Purdue Pharma
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-001Dec 30, 2008DISCNNo6,607,748<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
2,009,047,345<disabled in preview>
8,487,002Controlled-release compositions<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
Spain2310686Jan 16, 2009
Malaysia128308Jan 31, 2007
Germany60120413Jul 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.

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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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