Name: tramadol hydrochloride
Brand: ULTRAM

What is the patent landscape for Ultram, and when can generic versions of Ultram launch?

Ultram is a drug marketed by Janssen Pharms and Valeant Pharms and is included in two NDAs. 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-six suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

Summary for Tradename: ULTRAM

Patents:	1
Applicants:	2
NDAs:	2
Suppliers / Packagers: see list	3
Bulk Api Vendors: see list	28
Clinical Trials: see list	15
Patent Applications: see list	1,269
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	ULTRAM at DailyMed

Pharmacology for Tradename: ULTRAM

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

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Glossary

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Delist Req.	Exclusivity Expiration
Janssen Pharms	ULTRAM	tramadol hydrochloride	TABLET;ORAL	020281-002	Mar 3, 1995	AB	RX	Yes	Yes	6,339,105*PED	► Subscribe	Y	► Subscribe
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-002	Sep 8, 2005		DISCN	Yes	No		► Subscribe		► Subscribe
Janssen Pharms	ULTRAM	tramadol hydrochloride	TABLET;ORAL	020281-001	Mar 3, 1995		DISCN	No	No	6,339,105*PED	► Subscribe	Y	► Subscribe
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-001	Sep 8, 2005		DISCN	Yes	No		► Subscribe		► Subscribe
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-003	Sep 8, 2005		DISCN	Yes	No		► Subscribe		► Subscribe

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Paragraph IV activity for: ULTRAM

Drugname	Dosage	Strength	RLD	Submissiondate
tramadol hydrochloride	Extended-release Tablets	300 mg	Ultram ER	9/25/2007
tramadol hydrochloride	Extended-release Tablets	200 mg	Ultram ER	3/28/2007
tramadol hydrochloride	Extended-release Tablets	100 mg	Ultram ER	1/8/2007

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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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ULTRAM Drug Profile

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