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Serving leading biopharmaceutical companies globally:

US Army
Accenture
Chinese Patent Office
Julphar
Baxter
Argus Health
Harvard Business School
McKinsey
Citi
Fuji

Generated: February 19, 2018

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 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-seven 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

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
Accord Hlthcare TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 202390-001 May 16, 2013 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 205257-003 Dec 22, 2015 AB1 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-002 Dec 30, 2008 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mylan Pharms Inc TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 075980-001 Nov 21, 2002 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-001 Sep 8, 2005 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 204421-003 Oct 20, 2015 AB1 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-003 Dec 30, 2008 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Pliva TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 075982-001 Jul 1, 2002 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amneal Pharms TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 076003-001 Jun 20, 2002 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharma Global TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 201384-001 Dec 7, 2011 AB1 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
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-001 Sep 8, 2005 ➤ Sign Up ➤ Sign Up
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-003 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
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-003 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
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-001 Sep 8, 2005 ➤ Sign Up ➤ Sign Up
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-002 Dec 30, 2008 ➤ Sign Up ➤ Sign Up
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-003 Dec 30, 2008 ➤ Sign Up ➤ Sign Up
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-002 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
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
2,009,047,345 ➤ Sign Up
2,010,151,022 ➤ Sign Up
8,487,002 Controlled-release compositions ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for tramadol hydrochloride

Supplementary Protection Certificates for tramadol hydrochloride

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

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Deloitte
McKinsey
Express Scripts
Merck
Federal Trade Commission
QuintilesIMS
Daiichi Sankyo
Boehringer Ingelheim

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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