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Tramadol hydrochloride - Generic Drug Details

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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 Inc, 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.

This ingredient has one hundred and five patent family members in thirty-one countries.

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

Summary for Generic Name: tramadol hydrochloride

Tradenames:6
Patents:5
Applicants:31
NDAs:35
Drug Master File Entries: see list35
Suppliers / Packaging: see list65
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for Ingredient: tramadol hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Clinical Trials for: tramadol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Pharm Inc
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL078783-003Sep 20, 2011RXNo<disabled><disabled>
Aurobindo Pharma Ltd
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL204421-002Oct 20, 2015RXNo<disabled><disabled>
Valeant Pharms
ULTRAM ER
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021692-001Sep 8, 2005RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: tramadol hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-002Dec 30, 20086,254,887<disabled>
Valeant Pharms
ULTRAM ER
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021692-002Sep 8, 20057,074,430<disabled>
Valeant Pharms
ULTRAM ER
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021692-001Sep 8, 20056,254,887<disabled>
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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
8,487,002Controlled-release compositions<disabled in preview>
2,009,047,345<disabled in preview>
2,010,151,022<disabled in preview>
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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
JapanH1135450<disabled in preview>
South Korea20050088281<disabled in preview>
China100352509<disabled in preview>
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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<disabled>PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
C/GB04/012United Kingdom<disabled>PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
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