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Last Updated: October 24, 2020

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ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for acetaminophen; tramadol hydrochloride and what is the scope of freedom to operate?

Acetaminophen; tramadol hydrochloride is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Micro Labs Ltd India, Mylan, Nostrum Labs Inc, Par Pharm, Rising, Sun Pharm Inds Inc, Zydus Pharms Usa Inc, and Janssen Pharms, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty-six drug master file entries for acetaminophen; tramadol hydrochloride. Twenty-eight suppliers are listed for this compound.

Summary for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Recent Clinical Trials for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Walter Reed National Military Medical CenterN/A
Pain Management Institute Bethesda-Washington-MarylandN/A
Washington D.C. Veterans Affairs Medical CenterN/A

See all ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE clinical trials

Pharmacology for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Paragraph IV (Patent) Challenges for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ULTRACET TABLET;ORAL acetaminophen; tramadol hydrochloride 021123

US Patents and Regulatory Information for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Macleods Pharms Ltd TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 206885-001 May 2, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 207152-001 Mar 22, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Micro Labs Ltd India TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 201952-001 Dec 14, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 090485-001 Dec 9, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 077858-001 Sep 26, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Janssen Pharms ULTRACET acetaminophen; tramadol hydrochloride TABLET;ORAL 021123-001 Aug 15, 2001 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Rising TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 076914-001 Jul 26, 2006 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

Expired US Patents for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms ULTRACET acetaminophen; tramadol hydrochloride TABLET;ORAL 021123-001 Aug 15, 2001   Start Trial   Start Trial
Janssen Pharms ULTRACET acetaminophen; tramadol hydrochloride TABLET;ORAL 021123-001 Aug 15, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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