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Generated: October 21, 2017

DrugPatentWatch Database Preview

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 Sun Pharm Inds, Macleods Pharms Ltd, Lupin Ltd, Amneal Pharms, Zydus Pharms Usa Inc, Sun Pharma Global, Actavis Elizabeth, Aurobindo Pharma Ltd, Northstar Hlthcare, Purdue Pharma, Mylan Pharms Inc, Watson Labs, Ivax Sub Teva Pharms, Sun Pharm Inds Inc, Sandoz, Cipher Pharms Inc, Ipca Labs Ltd, Asta, Aci Healthcare Ltd, Teva, Apotex, Janssen Pharms, Pliva, Par Pharm Inc, Mallinckrodt, Mylan, Accord Hlthcare, Anchen Pharms, Valeant Pharms, Shionogi Inc, and Cspc Ouyi Pharm Co, 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.

Summary for Generic Name: tramadol hydrochloride

US Patents:5
Tradenames:6
Applicants:31
NDAs:35
Drug Master File Entries: see list36
Suppliers / Packagers: see list66
Bulk Api Vendors: see list50
Clinical Trials: see list2,496
Patent Applications: see list1,916
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:tramadol hydrochloride at DailyMed

Pharmacology for Ingredient: tramadol hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200503-001Aug 29, 2011AB1RXNoYes► Subscribe► Subscribe► Subscribe
Par Pharm Inc
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL078783-001Nov 13, 2009AB1RXNoNo► Subscribe► Subscribe► Subscribe
Macleods Pharms Ltd
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET;ORAL205702-001Sep 25, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Shionogi Inc
RYBIX ODT
tramadol hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021693-001May 5, 2005DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Mylan Pharms Inc
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL205257-002Dec 22, 2015AB1RXNoNo► Subscribe► Subscribe► Subscribe
Northstar Hlthcare
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET;ORAL078935-001May 26, 2010DISCNNoNo► Subscribe► Subscribe► Subscribe
Teva
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET;ORAL075977-001Jun 19, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
Asta
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET;ORAL075974-001Jul 12, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Ivax Sub Teva Pharms
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET;ORAL075963-001Jul 3, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET;ORAL076003-001Jun 20, 2002ABRXNoNo► 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
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-002Dec 30, 2008► Subscribe► Subscribe
Valeant Pharms
ULTRAM ER
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021692-003Sep 8, 2005► Subscribe► Subscribe
Valeant Pharms
ULTRAM ER
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021692-002Sep 8, 2005► Subscribe► Subscribe
Valeant Pharms
ULTRAM ER
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021692-001Sep 8, 2005► Subscribe► Subscribe
Shionogi Inc
RYBIX ODT
tramadol hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021693-001May 5, 2005► Subscribe► Subscribe
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-001Dec 30, 2008► Subscribe► Subscribe
Valeant Pharms
ULTRAM ER
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021692-001Sep 8, 2005► Subscribe► Subscribe
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-003Dec 30, 2008► Subscribe► Subscribe
Valeant Pharms
ULTRAM ER
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021692-003Sep 8, 2005► Subscribe► Subscribe
Valeant Pharms
ULTRAM ER
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021692-002Sep 8, 2005► 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
TaiwanI319713► Subscribe
Portugal1558935► Subscribe
Australia2003275854► Subscribe
Norway20052515► Subscribe
China100389752► Subscribe
Canada2503155► Subscribe
Australia708197► Subscribe
Russian Federation2333745► Subscribe
Czech Republic300152► Subscribe
Israel168113► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

UBS
Argus Health
Colorcon
Queensland Health
US Army
Deloitte
Novartis
Julphar
Johnson and Johnson
Fuji

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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