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Last Updated: January 19, 2020

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ULTRAM ER Drug Profile

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When do Ultram Er patents expire, and what generic alternatives are available?

Ultram Er is a drug marketed by Valeant Pharms and is included in one NDA.

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

US ANDA Litigation and Generic Entry Outlook for Ultram Er

  Start Trial

A generic version of ULTRAM ER was approved as tramadol hydrochloride by SUN PHARM INDS INC on January 19th, 2020.

Drug patent expirations by year for ULTRAM ER
Recent Clinical Trials for ULTRAM ER

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Rush University Medical CenterPhase 3
ITT Research InstitutePhase 1
PRA Health SciencesPhase 1

See all ULTRAM ER clinical trials

Recent Litigation for ULTRAM ER

Identify potential future generic entrants

District Court Litigation
Case NameDate
Purdue Pharma Products LP v. Lupin Ltd.2010-01-21
Purdue Pharma Products LP v. Impax Laboratories Inc.2008-08-15
Purdue Pharma Products LP v. Impax Laboratories Inc2008-08-08

See all ULTRAM ER litigation

Synonyms for ULTRAM ER
( inverted exclamation markA)-cis-2-(Dimethylaminomethyl)-1-(3-methoxyphenyl)cyclohexanol hydrochloride
(+-)-cis-2-((Dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol hydrochloride
(+-)-cis-2-((Dimethylamino)methyl)-1-(m-methoxyphenyl)cyclohexanol hydrochloride
(+-)-Tramadol
(+)-(1R,2R)-Tramadol hydrochloride
(+)-(R,R)-trans-
(+)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride
(+)-Tramadol
(+)-Tramadol Hydrochloride
(+)-Tramadol,hydrochloride
(+)-trans-2-(Dimethylaminomethyl)-1-(m-methoxyphenyl)cyclohexanol
(+)-trans-Tramadol free base
(+)-trans-Tramadol Hydrochloride
(1R-cis)-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride
(1R,2R)-2-((dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol
(1R,2R)-2-((Dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol hydrochloride
(1R,2R)-2-(dimethylaminomethyl)-1-(3-methoxyphenyl)-cyclohexanol
(1R,2R)-2-(Dimethylaminomethyl)-1-(3-methoxyphenyl)-cyclohexanol hydrochloride
(1R,2R)-2-(dimethylaminomethyl)-1-(3-methoxyphenyl)cyclohexan-1-ol
(1R,2R)-2-(dimethylaminomethyl)-1-(3-methoxyphenyl)cyclohexan-1-ol hydrochloride
(1R,2R)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol
(1R,2R)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol;hydrochloride
(1R,2R)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol
(1R,2R)-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride
(1R,2R)-2-[(dimethylamino)methyl]-1-[3-(methyloxy)phenyl]cyclohexanol
(1R,2R)-2-Dimethylaminomethyl-1-(3-methoxy-phenyl)-cyclohexanol
(1R,2R)-rel-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride
(r,r)-tramadol
(R,R)-tramadol hydrochloride
[(1R,2R)-2-hydroxy-2-(3-methoxyphenyl)cyclohexyl]-N,N-dimethylmethanaminium chloride
0NG5TTM63P
1109217-84-6
113683-92-4
123154-38-1
148229-78-1
181289-58-7
194602-08-9
204T882
22204-88-2
27203-92-5
36282-47-0
46941-74-6
53611-16-8
73806-46-9
914T774
AB00640024-11
AB1009456
AC-796
AC1L1Q6E
AC1L1Y7D
AC1Q59O2
Adolanta
AJ-07926
AKOS005066335
AKOS015907739
Amadol
Amanda (TN)
AN-15516
API0000066
API0000067
API0004460
API0004461
AX8154449
BC202864
BCP28607
BDBM50176259
Bellatram
BIDD:GT0075
Biomadol
C07153
C16H25NO2.HCl
CAS-36282-47-0
CCG-101135
Cemadol
CG 315
CG 315E
CG-315E
CHEBI:75725
CHEBI:75733
CHEMBL1066
CHEMBL1200336
CHEMBL201531
cis tramadol
cis-(+-)-E 383 hydrochloride
cis-(+/-)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol hydrochloride
cis-(+/-)-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride
cis-(1)-2-((Dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexan-1-ol hydrochloride
cis-Tramadol
cis-Tramadol hydrochloride
cis-Tramadol hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Contramal
Contramid
ConZip
CPD000449308
CS-2770
CTK8E8968
CTK8G3518
Cyclohexanol-2-((dimethylamino)methyl)-1-(3-methoxyphenyl)-, trans-(+-)- (9CI)
Cyclohexanol, 2-((dimethylamino)-1-(3-methoxyphenyl)-, cis-(+-)-
Cyclohexanol, 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)-, cis-(+-)-
Cyclohexanol, 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)-, hydrochloride, (1R,2R)-rel-
Cyclohexanol, 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)-, hydrochloride, cis-
Cyclohexanol, 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)-, hydrochloride, cis-( -)-
Cyclohexanol, 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)-, hydrochloride, cis-(+-)-
Cyclohexanol, 2-((dimethylamino)methyl)-1-(m-methoxyphenyl)-
Cyclohexanol, 2-((dimethylamino)methyl)-1-(m-methoxyphenyl)-, hydrochloride, cis-(+-)-
Cyclohexanol, 2-(dimethylaminomethyl)-1-(m-methoxyphenyl)-, (+)-(E)-
D01355
D08623
DB00193
Dolana
DSSTox_CID_3691
DSSTox_GSID_23691
DSSTox_RID_77150
DTXSID7023691
DTXSID90858931
E 265
E 382
EINECS 248-319-6
EINECS 252-950-2
EINECS 258-662-3
FT-0604438
FT-0638197
FT-0675345
FT-0675346
FT-0675347
HMS2090D10
HMS2803D04
HSDB 7047
HY-B0582A
I14-16782
I14-2711
I14-40832
I14-41530
Ira-Tramadol
Jsp004511
Jsp005295
K-8120
KS-1124
Labesfal
LS-174590
LS-191406
LS-57115
LS-57116
LS-57120
Mabron
MCULE-3504250719
MCULE-8198453745
Melanate
MLS000333190
MLS000758218
MLS001424208
NC00385
NCGC00159343-02
NCGC00159343-05
NIH 10969
Omnidol
Poltram
PPKXEPBICJTCRU-XMZRARIVSA-N
PubChem20420
Q-201847
Racemic tramadol
Radol
Ralivia ER
Ralivia flashtab
Rel-Tramadol
RT-015839
RT-015840
Rybix
Rybix ODT
Ryzolt
SAM001246847
SAM001247044
SC-77562
SCHEMBL41748
SCHEMBL7464
SMR000436547
SMR000449308
SR-01000759320
SR-01000759320-5
sustained-release tramadol
Synapryn
Tadol
TL8001847
Tox21_111588
Tox21_111588_1
Trabar
Tradol-Puren
Tradonal
Tradonal odis
Tramadex
Tramadis
Tramadol
Tramadol (INN)
Tramadol [INN:BAN]
Tramadol Contramid
Tramadol HCl
Tramadol HCl BP/EP
Tramadol HCl; (+/-)cis-2-((Dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanolhydrochloride
tramadol hydrochloride
Tramadol hydrochloride (JAN/USAN)
Tramadol hydrochloride [USAN:JAN]
Tramadol hydrochloride [USAN:USP:JAN]
Tramadol Hydrochloride 1.0 mg/ml in Methanol (as free base)
tramadol hydrochloride tablets
Tramadol hydrochloride, >=98% (HPLC), solid
Tramadol hydrochloride, >=99.0% (HPLC)
Tramadol hydrochloride, British Pharmacopoeia (BP) Reference Standard
Tramadol hydrochloride, European Pharmacopoeia (EP) Reference Standard
Tramadol hydrochloride, United States Pharmacopeia (USP) Reference Standard
Tramadol, (+)-
TRAMADOL/HCL
tramadole hydrochloride
Tramadolum
Tramadolum [INN-Latin]
Tramadon
Tramagetic
Tramal
Tramal Retard
Tramaliv
Tramazac
Tramed
Tramodol Hcl
Tramol
trans-(+/-)-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol hydrochloride
Trapidol
Tridol
Tridural
TVYLLZQTGLZFBW-ZBFHGGJFSA-N
U 26,225A
U 26255A
U-26,225A
U-26225A
Ultram (TN)
UNII-0NG5TTM63P
UNII-39J1LGJ30J component TVYLLZQTGLZFBW-ZBFHGGJFSA-N
UNII-9N7R477WCK component PPKXEPBICJTCRU-XMZRARIVSA-N
Viotra
W0081
ZINC853
Zumatran
Zydol
Zydol hydrochloride
Zydol XL 150
Zytram
Paragraph IV (Patent) Challenges for ULTRAM ER
Tradename Dosage Ingredient NDA Submissiondate
ULTRAM ER TABLET, EXTENDED RELEASE;ORAL tramadol hydrochloride 021692 2007-09-25
ULTRAM ER TABLET, EXTENDED RELEASE;ORAL tramadol hydrochloride 021692 2007-03-28
ULTRAM ER TABLET, EXTENDED RELEASE;ORAL tramadol hydrochloride 021692 2007-01-08

US Patents and Regulatory Information for ULTRAM ER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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 021692-002 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

Expired US Patents for ULTRAM ER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-003 Sep 8, 2005   Start Trial   Start Trial
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-001 Sep 8, 2005   Start Trial   Start Trial
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-001 Sep 8, 2005   Start Trial   Start Trial
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-003 Sep 8, 2005   Start Trial   Start Trial
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-002 Sep 8, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Medtronic
Merck
McKinsey
Colorcon
Johnson and Johnson

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