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Serving leading biopharmaceutical companies globally:

Fish and Richardson
QuintilesIMS
Healthtrust
Merck
Colorcon
Citi
Farmers Insurance
Chinese Patent Office
Express Scripts
Moodys

Generated: December 14, 2017

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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, Ipca Labs Ltd, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Mallinckrodt, Mylan, Northstar Hlthcare, Pliva, Sandoz, 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 five patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tramadol hydrochloride has one hundred and sixteen patent family members in thirty-one countries and two supplementary protection certificates in two countries.

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

Pharmacology for tramadol hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Medical Subject Heading (MeSH) Categories for tramadol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Actavis ElizabethTRAMADOL HYDROCHLORIDEtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL091609-002Jun 27, 2012AB2RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdTRAMADOL HYDROCHLORIDEtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL204421-001Oct 20, 2015AB1RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdTRAMADOL HYDROCHLORIDEtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL204421-002Oct 20, 2015AB1RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Valeant PharmsULTRAM ERtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL021692-001Sep 8, 2005DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncTRAMADOL HYDROCHLORIDEtramadol hydrochlorideTABLET;ORAL075980-001Nov 21, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis ElizabethTRAMADOL HYDROCHLORIDEtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL091609-003Jun 27, 2012AB2RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sun Pharma GlobalTRAMADOL HYDROCHLORIDEtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL201384-003Dec 7, 2011AB1RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Lupin LtdTRAMADOL HYDROCHLORIDEtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200503-001Aug 29, 2011AB1RXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Valeant PharmsULTRAM ERtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL021692-002Sep 8, 2005DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdTRAMADOL HYDROCHLORIDEtramadol hydrochlorideTABLET;ORAL203494-001Mar 31, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: tramadol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shionogi IncRYBIX ODTtramadol hydrochlorideTABLET, ORALLY DISINTEGRATING;ORAL021693-001May 5, 2005► Subscribe► Subscribe
Valeant PharmsULTRAM ERtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL021692-003Sep 8, 2005► Subscribe► Subscribe
Valeant PharmsULTRAM ERtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL021692-002Sep 8, 2005► Subscribe► Subscribe
Purdue PharmaRYZOLTtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL021745-001Dec 30, 2008► Subscribe► Subscribe
Valeant PharmsULTRAM ERtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL021692-003Sep 8, 2005► Subscribe► Subscribe
Valeant PharmsULTRAM ERtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL021692-001Sep 8, 2005► Subscribe► Subscribe
Purdue PharmaRYZOLTtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL021745-003Dec 30, 2008► Subscribe► Subscribe
Purdue PharmaRYZOLTtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL021745-002Dec 30, 2008► Subscribe► Subscribe
Purdue PharmaRYZOLTtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL021745-003Dec 30, 2008► Subscribe► Subscribe
Purdue PharmaRYZOLTtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL021745-002Dec 30, 2008► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
2,009,047,345► Subscribe
8,487,002Controlled-release compositions► Subscribe
2,010,151,022► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: tramadol hydrochloride

Country Document Number Estimated Expiration
Denmark1003484► Subscribe
SloveniaEP1558935► Subscribe
Denmark1594460► Subscribe
Denmark1558935► Subscribe
Ukraine84277► Subscribe
Spain2167921► Subscribe
Germany60322091► Subscribe
Slovenia1305009► Subscribe
Canada2495463► Subscribe
Spain2272499► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TRAMADOL HYDROCHLORIDE

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

Moodys
Covington
US Army
Novartis
QuintilesIMS
Medtronic
Federal Trade Commission
Dow
US Department of Justice
Mallinckrodt

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.

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