Acetaminophen; benzhydrocodone hydrochloride - Generic Drug Details

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

Acetaminophen; benzhydrocodone hydrochloride is the generic ingredient in one branded drug marketed by Zevra Therap and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acetaminophen; benzhydrocodone hydrochloride has thirty-five patent family members in twenty countries.

Summary for acetaminophen; benzhydrocodone hydrochloride

International Patents:	35
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
DailyMed Link:	acetaminophen; benzhydrocodone hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for acetaminophen; benzhydrocodone hydrochloride

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

US Patents and Regulatory Information for acetaminophen; benzhydrocodone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-001	Feb 23, 2018		DISCN	Yes	No			Y	Y
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-001	Feb 23, 2018		DISCN	Yes	No			Y	Y
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-001	Feb 23, 2018		DISCN	Yes	No			Y	Y
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-001	Feb 23, 2018		DISCN	Yes	No			Y
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-002	Jan 4, 2019		DISCN	Yes	No			Y
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-002	Jan 4, 2019		DISCN	Yes	No			Y	Y
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-003	Jan 4, 2019		DISCN	Yes	No			Y	Y

International Patents for acetaminophen; benzhydrocodone hydrochloride

Country	Patent Number	Title	Estimated Expiration
South Africa	201300747	BENZOIC ACID,BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE,PRODRUGS,METHODS OF MAKING AND USE THEREOF
China	102480959	Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Canada	2766388	ACIDE BENZOIQUE, DERIVES D'ACIDE BENZOIQUE ET CONJUGUES D'ACIDEHETEROARYLCARBOXYLIQUEE D'HYDROCODONE, PROMEDICAMENTS, LEURS PROCEDES DE FABRICATION ET D'UTILISATION (BENZOIC ACID, BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE, PRODRUGS, METHODS OF MAKING AND USE THEREOF)
Chile	2011003347	Composicion farmaceutica que comprende un conjugado, correspondiente a benzoato de hidrocodona ; y uso en el tratamiento de una enfermedad, trastorno o afeccion mediada por la union de un opioide a receptores opioides.
Israel	217096	תכשירים הכוללים תצמידים של בנזואט הידרוקודון ושימושים בהם (Compositions comprising conjugates of benzoate hydrocodone and use thereof)
Japan	5442862
Brazil	112012000569	ácido benzóico, derivados de ácido benzóico e conjugados de ácido heteroaril carboxílico de hidrocodona, pró-farmacos, métodos de produção e uso destes