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Last Updated: August 10, 2020

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TRAMADOL HYDROCHLORIDE Drug Profile

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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, Par Pharm Inc, Sun Pharm, 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 Pharms Inc, Northstar Hlthcare, Pliva, Polygen Pharms, Rubicon, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Unichem Labs Ltd, Watson Labs, Zydus Pharms Usa Inc, Alkem Labs Ltd, Graviti Pharms, Micro Labs Ltd India, Nostrum Labs Inc, and Par Pharm. and is included in forty-four NDAs.

The generic ingredient in TRAMADOL HYDROCHLORIDE is acetaminophen; tramadol hydrochloride. There are sixty-six drug master file entries for this compound. Twenty-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
Recent Clinical Trials for TRAMADOL HYDROCHLORIDE

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SponsorPhase
Washington D.C. Veterans Affairs Medical CenterN/A
Pain Management Institute Bethesda-Washington-MarylandN/A
Scilex Pharmaceuticals, Inc.N/A

See all TRAMADOL HYDROCHLORIDE clinical trials

Pharmacology for TRAMADOL HYDROCHLORIDE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for TRAMADOL HYDROCHLORIDE
Paragraph IV (Patent) Challenges for TRAMADOL HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
RYZOLT TABLET, EXTENDED RELEASE;ORAL tramadol hydrochloride 021745 2009-06-18
ULTRAM ER TABLET, EXTENDED RELEASE;ORAL tramadol hydrochloride 021692 2007-09-25
ULTRAM ER TABLET, EXTENDED RELEASE;ORAL tramadol hydrochloride 021692 2007-03-28
ULTRAM ER TABLET, EXTENDED RELEASE;ORAL tramadol hydrochloride 021692 2007-01-08
ULTRAM TABLET;ORAL tramadol hydrochloride 020281

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
Polygen Pharms TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 206706-001 Jul 2, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Cspc Ouyi Pharm Co TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 091498-001 Mar 29, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 075962-001 Jun 24, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
>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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