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Generated: April 26, 2018

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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 tramadol hydrochloride 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 Pharms Inc, Par Pharm Inc, Sun Pharma Global, 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, Northstar Hlthcare, Pliva, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Watson Labs, Zydus Pharms Usa Inc, and Janssen Pharms, and is included in thirty-five 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-two patent family members in twenty-nine countries.

There are thirty-six drug master file entries for tramadol hydrochloride. Sixty-five suppliers are listed for this compound.
Summary for tramadol hydrochloride
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
(+)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride
(+)-Tramadol Hydrochloride
(+)-Tramadol-d6 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
22203-92-5
22204-88-2
36282-47-0
53611-16-8
AB1009456
AC-796
AC1L1Y7D
Adolanta
AK153206
AK402423
AKOS015907739
Amadol
AN-15516
API0000067
API0004461
AX8154449
BC202864
Bellatram
C16H25NO2.HCl
CCG-101135
Cemadol
CG 315
CG-315E
CHEBI:75733
CHEMBL1200336
cis-(+-)-E 383 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
MFCD00798507
MLS000758218
MLS001424208
NC00385
NIH 10969
Omnidol
Poltram
PPKXEPBICJTCRU-XMZRARIVSA-N
Q-201847
Radol
RT-015840
Rybix
Rybix ODT
SAM001246847
SAM001247044
SBB067292
SC-77562
SCHEMBL41748
SMR000449308
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
TRAMADOLHydrochloride
Tramagetic
Tramal
Tramal Retard
Tramazac
Tramed
Tramol
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
Aurobindo Pharma Ltd TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 203494-001 Mar 31, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lupin Ltd TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200503-003 Aug 29, 2011 AB1 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 204421-002 Oct 20, 2015 AB1 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Elizabeth TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 091609-003 Jun 27, 2012 AB2 RX No 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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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 021745-003 Dec 30, 2008 ➤ Sign Up ➤ Sign Up
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-002 Sep 8, 2005 ➤ Sign Up ➤ Sign Up
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-001 Dec 30, 2008 ➤ Sign Up ➤ Sign Up
Shionogi Inc RYBIX ODT tramadol hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021693-001 May 5, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for tramadol hydrochloride

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
8,487,002 Controlled-release compositions ➤ Sign Up
2,009,047,345 ➤ Sign Up
6,605,644 Analgesic regimen ➤ Sign Up
2,010,151,022 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for tramadol hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00152 Netherlands ➤ Sign Up PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
C/GB04/012 United Kingdom ➤ Sign Up PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Harvard Business School
Federal Trade Commission
Covington
Chubb
McKesson
Medtronic
Express Scripts
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.