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Last Updated: October 20, 2019

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Tramadol hydrochloride - Generic Drug Details

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What are the generic drug sources for tramadol hydrochloride and what is the scope of patent protection?

Tramadol hydrochloride is the generic ingredient in six branded drugs marketed by Cipher Pharms Inc, Purdue Pharma, Actavis Elizabeth, Anchen Pharms, Aurobindo Pharma Ltd, Lupin Ltd, Mylan, Par Pharm Inc, Sun Pharm, Valeant Pharms, Shionogi Inc, Accord Hlthcare, Aci Healthcare Ltd, Amneal Pharms, Apotex, Asta, Cspc Ouyi Pharm Co, Fosun Pharma, Ipca Labs Ltd, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Mylan Pharms Inc, Northstar Hlthcare, Pliva, Polygen Pharms, Rubicon, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Unichem Labs Ltd, Watson Labs, Zydus Pharms Usa Inc, and Janssen Pharms, and is included in thirty-eight NDAs. There are four patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tramadol hydrochloride has ninety-three patent family members in twenty-nine countries.

There are thirty-six drug master file entries for tramadol hydrochloride. Fifty-three suppliers are listed for this compound.

Recent Clinical Trials for tramadol hydrochloride

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

SponsorPhase
Rambam Health Care CampusN/A
University Medical Centre LjubljanaN/A
University Hospital, ToursN/A

See all tramadol hydrochloride clinical trials

Recent Litigation for tramadol hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Purdue Pharma L.P. v. Depomed, Inc.2015-09-15
Takeda Pharmaceutical Co. v. Zydus Pharmaceuticals USA2013-05-15
TAKEDA PHARMACEUTICAL COMPANY LIMITED v. ZYDUS PHARMACEUTICALS (USA) INC.2010-04-05

See all tramadol hydrochloride litigation

Pharmacology for tramadol hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for tramadol hydrochloride
Synonyms for tramadol hydrochloride
( 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
(+)-(1R,2R)-Tramadol hydrochloride
(+)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride
(+)-Tramadol Hydrochloride
(+)-Tramadol,hydrochloride
(+)-trans-Tramadol Hydrochloride
(1R-cis)-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride
(1R,2R)-2-((Dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol hydrochloride
(1R,2R)-2-(Dimethylaminomethyl)-1-(3-methoxyphenyl)-cyclohexanol hydrochloride
(1R,2R)-2-(dimethylaminomethyl)-1-(3-methoxyphenyl)cyclohexan-1-ol hydrochloride
(1R,2R)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol;hydrochloride
(1R,2R)-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride
(1R,2R)-rel-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride
(R,R)-tramadol hydrochloride
[(1R,2R)-2-hydroxy-2-(3-methoxyphenyl)cyclohexyl]-N,N-dimethylmethanaminium chloride
1109217-84-6
148229-78-1
194602-08-9
204T882
22204-88-2
36282-47-0
53611-16-8
AB1009456
AC-796
AC1L1Y7D
Adolanta
AKOS015907739
Amadol
AN-15516
API0000067
API0004461
AX8154449
BC202864
BCP28607
Bellatram
C16H25NO2.HCl
CCG-101135
Cemadol
CG 315
CG-315E
CHEBI:75733
CHEMBL1200336
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 hydrochloride
cis-Tramadol hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Contramal
ConZip
CPD000449308
CS-2770
CTK8G3518
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)-, hydrochloride, cis-(+-)-
D01355
Dolana
DTXSID7023691
E 382
EINECS 252-950-2
EINECS 258-662-3
FT-0638197
FT-0675345
FT-0675347
HSDB 7047
HY-B0582A
I14-2711
Ira-Tramadol
Jsp004511
K-8120
KS-1124
LS-174590
LS-191406
LS-57120
Mabron
MCULE-3504250719
Melanate
MLS000758218
MLS001424208
NC00385
NIH 10969
Omnidol
Poltram
PPKXEPBICJTCRU-XMZRARIVSA-N
Q-201847
Radol
RT-015840
Rybix
Rybix ODT
Ryzolt
SAM001246847
SAM001247044
SC-77562
SCHEMBL41748
SMR000449308
SR-01000759320
SR-01000759320-5
Synapryn
Tadol
TL8001847
Trabar
Tradol-Puren
Tradonal
Tramadex
Tramadol HCl
Tramadol HCl; (+/-)cis-2-((Dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanolhydrochloride
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/HCL
tramadole hydrochloride
Tramagetic
Tramal
Tramal Retard
Tramazac
Tramed
Tramol
trans-(+/-)-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol hydrochloride
Tridol
Tridural
U 26,225A
U-26,225A
U-26225A
Ultram (TN)
Ultram ER
UNII-9N7R477WCK component PPKXEPBICJTCRU-XMZRARIVSA-N
Viotra
W0081
Zumatran
Zydol
Zydol hydrochloride
Zydol XL 150

US Patents and Regulatory Information for tramadol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Anchen Pharms TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200491-002 Jun 27, 2012 AB2 RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 205702-001 Sep 25, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Aci Healthcare Ltd TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 202075-001 Nov 28, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Polygen Pharms TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 206706-001 Jul 2, 2019 AB RX No 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 tramadol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-002 Dec 30, 2008   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
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-001 Sep 8, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for tramadol hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0566709 SPC/GB04/012 United Kingdom   Start Trial PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
0566709 C300152 Netherlands   Start Trial PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School
Colorcon
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AstraZeneca

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