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Generated: May 24, 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 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 six 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 five patent family members in thirty-one countries.

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

Summary for Generic Name: tramadol hydrochloride

Drug Master File Entries: see list36
Suppliers / Packagers: see list69
Bulk Api Vendors: see list50
Clinical Trials: see list1,085
Patent Applications: see list1,841
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
tramadol hydrochloride
TABLET;ORAL075983-001Jun 25, 2002ABRXNoNo► Subscribe► Subscribe
Purdue Pharma
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-002Dec 30, 2008DISCNYesNo6,607,748► SubscribeY ► Subscribe
Purdue Pharma
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-003Dec 30, 2008DISCNYesNo7,988,998► SubscribeY ► Subscribe
Accord Hlthcare
tramadol hydrochloride
TABLET;ORAL202390-001May 16, 2013ABRXNoNo► Subscribe► Subscribe
Sun Pharma Global
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL091607-001Dec 30, 2011AB2RXNoYes► Subscribe► Subscribe
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