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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 four patents protecting this drug and one Paragraph IV challenge.

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

Suppliers: see list2

Pharmacology for Tradename: RYZOLT

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Clinical Trials for: RYZOLT

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

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

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

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

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

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

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

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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;ORAL021745Dec 30, 2008DISCNNo6,254,887<disabled>Y<disabled>
Purdue Pharma
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745Dec 30, 2008DISCNNo6,607,748<disabled>Y<disabled>
Purdue Pharma
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745Dec 30, 2008DISCNNo5,591,452<disabled>Y<disabled>
Purdue Pharma
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745Dec 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
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Preferred citation:

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

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