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Details for Generic Name: tramadol hydrochloride

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Tramadol hydrochloride is the generic ingredient in six branded drugs marketed by Cipher Pharms Inc, Purdue Pharma, Actavis Elizabeth, Anchen Pharms, Lupin Ltd, Par Pharm Inc, Sun Pharma Global, Valeant Intl, Shionogi Inc, Accord Hlthcare Inc, Allied Pharma Inc, Amneal Pharms, Apotex, Asta, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Ipca Labs Ltd, Ivax Sub Teva Pharms, Mallinckrodt, Mutual Pharm, Mylan, Mylan Pharms Inc, Northstar Hlthcare, Pliva, Sandoz, Sun Pharm Inds Inc, Teva, Watson Labs, Zydus Pharms Usa Inc, and Janssen Pharms, and is included in thirty-two NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: tramadol hydrochloride

Tradenames:6
Patents:7
Applicants:30
NDAs:32
Drug Master File Entries: see list35
Suppliers: see list19
Therapeutic Class:Analgesics

Pharmacology for Ingredient: tramadol hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Clinical Trials for: tramadol hydrochloride

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
ULTRAM
tramadol hydrochloride
TABLET;ORAL020281Mar 3, 1995DISCNNo6,339,105*PED<disabled>Y<disabled>
Watson Labs
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET;ORAL075962Jun 24, 2002DISCNNo<disabled><disabled>
Janssen Pharms
ULTRAM
tramadol hydrochloride
TABLET;ORAL020281Mar 3, 1995RXYes6,339,105*PED<disabled>Y<disabled>
Northstar Hlthcare
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET;ORAL078935May 26, 2010RXNo<disabled><disabled>
Accord Hlthcare Inc
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET;ORAL202390May 16, 2013RXNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:
Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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