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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Dow
Fuji
McKesson
Harvard Business School
Citi
McKinsey
Cantor Fitzgerald
Baxter

Generated: April 24, 2018

DrugPatentWatch Database Preview

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.
Drug patent expirations by year for ULTRAM
Pharmacology for ULTRAM
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for ULTRAM
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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-002 Sep 8, 2005 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms ULTRAM tramadol hydrochloride TABLET;ORAL 020281-001 Mar 3, 1995 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-001 Sep 8, 2005 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for ULTRAM
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Tablets 300 mg ➤ Subscribe 2007-09-25
➤ Subscribe Extended-release Tablets 200 mg ➤ Subscribe 2007-03-28
➤ Subscribe Extended-release Tablets 100 mg ➤ Subscribe 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 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Deloitte
Daiichi Sankyo
Covington
UBS
Fuji
Chinese Patent Office
Cipla
Teva

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.