Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

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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-two suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

Drug patent expirations by year for ULTRAM
Drug Prices for ULTRAM

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Drug Sales Revenue Trends for ULTRAM

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Recent Clinical Trials for ULTRAM

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SponsorPhase
Rush University Medical CenterPhase 3
PRA Health SciencesPhase 1
DF/Net RearchPhase 1

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Pharmacology for ULTRAM
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Synonyms for ULTRAM
(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-[(DIMETHYLAMINO)METHYL]-1-(3-METHOXYPHENYL)CYCLOHEXAN-1-OL
2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol
2-Dimethylaminomethyl-1-(m-methoxyphenyl)cyclohexanol
2914-77-4
AC1L1KJ8
AC1Q7AST
ACM2914774
AKOS022507395
AN-32783
CHEBI:75722
CHEMBL1237044
COR0000099
CTK4G2807
Cyclohexanol, 2-(dimethylaminomethyl)-1-(m-methoxyphenyl)-
Cyclohexanol, 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-
Cyclohexanol,2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-
EINECS 220-831-4
GTPL8286
L000985
LS-57112
LS-57113
LS-57114
Maxitram
MCULE-1882520267
SCHEMBL57496
Tilodol
TVYLLZQTGLZFBW-UHFFFAOYSA-N
Paragraph IV (Patent) Challenges for ULTRAM
Tradename Dosage Ingredient NDA Submissiondate
ULTRAM TABLET;ORAL tramadol hydrochloride 020281

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   Start Trial   Start Trial Y   Start Trial
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-002 Sep 8, 2005 DISCN Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms ULTRAM tramadol hydrochloride TABLET;ORAL 020281-001 Mar 3, 1995 DISCN No No   Start Trial   Start Trial Y   Start Trial
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-001 Sep 8, 2005 DISCN Yes No   Start Trial   Start Trial   Start Trial
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-003 Sep 8, 2005 DISCN Yes No   Start Trial   Start Trial   Start Trial
>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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