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ULTRAM Drug Profile

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Ultram is a drug marketed by Janssen Pharms and Valeant Pharms and is included in two NDAs. It is available from four suppliers. There is one patent protecting this drug and three Paragraph IV challenges.

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

Summary for Tradename: ULTRAM

Suppliers / Packagers: see list4
Bulk Api Vendors: see list28
Clinical Trials: see list8
Patent Applications: see list7,262
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ULTRAM at DailyMed

Pharmacology for Tradename: ULTRAM

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
tramadol hydrochloride
TABLET;ORAL020281-002Mar 3, 1995RXYesYes6,339,105*PED► subscribeY► subscribe
Valeant Pharms
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021692-002Sep 8, 2005DISCNNoNo► subscribe► subscribe
Janssen Pharms
tramadol hydrochloride
TABLET;ORAL020281-001Mar 3, 1995DISCNNoNo6,339,105*PED► subscribeY► subscribe
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Paragraph IV activity for: ULTRAM

Drugname Dosage Strength RLD Submissiondate
tramadol hydrochlorideExtended-release Tablets300 mgUltram ER9/25/2007
tramadol hydrochlorideExtended-release Tablets200 mgUltram ER3/28/2007
tramadol hydrochlorideExtended-release Tablets100 mgUltram ER1/8/2007
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