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Last Updated: November 4, 2024

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, Chartwell Rx, Graviti Pharms, Macleods Pharms Ltd, Micro Labs Ltd India, Nostrum Labs Inc, 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.

Seventeen 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
University Hospital "Sestre Milosrdnice"N/A
Novartis PharmaceuticalsPhase 3
Bhupesh Parashar, MDPhase 2

See all ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE clinical trials

Pharmacology for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Anatomical Therapeutic Chemical (ATC) Classes for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

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
Micro Labs Ltd India TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 201952-001 Dec 14, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkem Labs Ltd TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 202076-001 Mar 30, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms Usa Inc TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 090460-001 Sep 6, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms ULTRACET acetaminophen; tramadol hydrochloride TABLET;ORAL 021123-001 Aug 15, 2001 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Graviti Pharms TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 076914-001 Jul 26, 2006 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 076475-001 Apr 21, 2005 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 077858-001 Sep 26, 2008 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms ULTRACET acetaminophen; tramadol hydrochloride TABLET;ORAL 021123-001 Aug 15, 2001 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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