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ULTRAM Drug Profile

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When do Ultram patents expire, 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. Fifty-one suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

Summary for ULTRAM

US Patents:	1
Applicants:	2
NDAs:	2
Suppliers / Packagers:	3
Bulk Api Vendors:	18
Clinical Trials:	16
Patent Applications:	121
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	ULTRAM at DailyMed

Pharmacology for ULTRAM

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for ULTRAM

Analgesics, Opioid

Narcotics

Synonyms for ULTRAM

(-)-2-[(DIMETHYLAMINO)METHYL]-1-(3-METHOXYPHENYL)CYCLOHEXANOL

(1RS,2RS)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-cyclo-hexanol

(1RS,2RS)-2-dimethylaminomethyl-1-(3-methoxy-phenyl)-cyclohexanol

1-(m-Methoxyphenyl)-2-(dimethylaminomethyl)cyclohexane-1-ol

2-((Dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexan-1-ol

2-(dimethylaminomethyl)-1-(3-methoxyphenyl)cyclohexan-1-ol

2-[ methyl]-1- cyclohexan-1-ol

2-[(DIMETHYLAMINO)METHYL]-1-(3-METHOXYPHENYL)CYCLOHEXAN-1-OL

2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol

2-Dimethylaminomethyl-1-(m-methoxyphenyl)cyclohexanol

2914-77-4

3B1-000741

AC1L1KJ8

AC1Q7AST

ACM2914774

AKOS022507395

AN-32783

CHEBI:75722

CHEMBL1237044

ConZip

COR0000099

CTK4G2807

Cyclohexanol, 2-(dimethylaminomethyl)-1-(m-methoxyphenyl)-

Cyclohexanol, 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-

Cyclohexanol,2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-

D05GKD

EINECS 220-831-4

GTPL8286

L000985

LS-57112

LS-57113

LS-57114

Maxitram

MCULE-1882520267

OR009034

OR148688

OR148689

Rybix ODT

Ryzolt

SCHEMBL57496

Tilodol

TVYLLZQTGLZFBW-UHFFFAOYSA-N

US Patents and Regulatory Information for ULTRAM

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

Paragraph IV (Patent) Challenges for ULTRAM

Drugname	Dosage	Strength	RLD	Submissiondate
	Extended-release Tablets	300 mg		2007-09-25
	Extended-release Tablets	200 mg		2007-03-28
	Extended-release Tablets	100 mg		2007-01-08

Non-Orange Book US Patents for ULTRAM

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
6,605,644	Analgesic regimen