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Generated: December 17, 2017

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When do Tramadol Hydrochloride patents expire, and what generic alternatives are available?

Tramadol Hydrochloride is a drug marketed by Actavis Elizabeth, Anchen Pharms, Aurobindo Pharma Ltd, Lupin Ltd, Mylan Pharms Inc, Par Pharm Inc, Sun Pharma Global, 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, Apogee Pharma, Apotex Inc, Micro Labs Ltd India, and Par Pharm. and is included in forty-one NDAs.

The generic ingredient in TRAMADOL HYDROCHLORIDE is acetaminophen; tramadol hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.
Drug patent expirations by year for TRAMADOL HYDROCHLORIDE


Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
SandozTRAMADOL HYDROCHLORIDEtramadol hydrochlorideTABLET;ORAL075968-001Jun 25, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Cspc Ouyi Pharm CoTRAMADOL HYDROCHLORIDEtramadol hydrochlorideTABLET;ORAL091498-001Mar 29, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex IncTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENacetaminophen; tramadol hydrochlorideTABLET;ORAL078778-001Apr 7, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson LabsTRAMADOL HYDROCHLORIDEtramadol hydrochlorideTABLET;ORAL075962-001Jun 24, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENacetaminophen; tramadol hydrochlorideTABLET;ORAL207152-001Mar 22, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Par PharmTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENacetaminophen; tramadol hydrochlorideTABLET;ORAL076475-001Apr 21, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Amneal PharmsTRAMADOL HYDROCHLORIDEtramadol hydrochlorideTABLET;ORAL076003-001Jun 20, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
Ipca Labs LtdTRAMADOL HYDROCHLORIDEtramadol hydrochlorideTABLET;ORAL201973-001Nov 16, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
ApotexTRAMADOL HYDROCHLORIDEtramadol hydrochlorideTABLET;ORAL075981-001Jul 10, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis ElizabethTRAMADOL HYDROCHLORIDEtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL091609-001Jun 27, 2012AB2RXNoNo► Subscribe► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

US Department of Justice
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Fish and Richardson
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