Acetaminophen; tramadol hydrochloride - Generic Drug Details

What are the generic sources for acetaminophen; tramadol hydrochloride and what is the scope of patent protection?

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

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	12
Finished Product Suppliers / Packagers:	17
Clinical Trials:	80
DailyMed Link:	acetaminophen; tramadol hydrochloride at DailyMed

Recent Clinical Trials for acetaminophen; tramadol hydrochloride

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

Sponsor	Phase
University Hospital "Sestre Milosrdnice"	N/A
Novartis Pharmaceuticals	Phase 3
Bhupesh Parashar, MD	Phase 2

See all acetaminophen; tramadol hydrochloride clinical trials

Pharmacology for acetaminophen; tramadol hydrochloride

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for acetaminophen; tramadol hydrochloride

N02AX	Other opioids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

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
Zydus Pharms Usa Inc	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	acetaminophen; tramadol hydrochloride	TABLET;ORAL	090460-001	Sep 6, 2012	AB	RX	No	No
Graviti Pharms	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	acetaminophen; tramadol hydrochloride	TABLET;ORAL	076914-001	Jul 26, 2006		DISCN	No	No
Janssen Pharms	ULTRACET	acetaminophen; tramadol hydrochloride	TABLET;ORAL	021123-001	Aug 15, 2001		DISCN	Yes	No
Alkem Labs Ltd	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	acetaminophen; tramadol hydrochloride	TABLET;ORAL	202076-001	Mar 30, 2012	AB	RX	No	No
Aurobindo Pharma	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	acetaminophen; tramadol hydrochloride	TABLET;ORAL	207152-001	Mar 22, 2017	AB	RX	No	No
Rising	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	acetaminophen; tramadol hydrochloride	TABLET;ORAL	077858-001	Sep 26, 2008	AB	RX	No	No

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
Janssen Pharms	ULTRACET	acetaminophen; tramadol hydrochloride	TABLET;ORAL	021123-001	Aug 15, 2001