ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE - Generic Drug Details

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

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	208653-003	Jan 4, 2019		DISCN	Yes	No			Y	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
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	208653-003	Jan 4, 2019		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	208653-002	Jan 4, 2019		DISCN	Yes	No			Y

International Patents for ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Colombia	6480991	ACIDO BENZOICO, DERIVADOS DE ACIDO BENZOICO Y CONJUGADOS DE ACIDO HETEROARIL CARBOXILICO DE HIDROCODONA, PROFARMACOS, METODOS PARA ELABORAR Y UTILIZAR LOS MISMOS
Singapore	177445	BENZOIC ACID, BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE, PRODRUGS, METHODS OF MAKING AND USE THEREOF
South Korea	20160106781	히드로코돈의 벤조산, 벤조산 유도체 및 헤테로아릴 카르복실산 콘쥬게이트, 이의 전구약물, 제조 방법 및 용도 (BENZOIC ACID, BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE, PRODRUGS, METHODS OF MAKING AND USE THEREOF)
South Korea	20120048589	BENZOIC ACID, BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE, PRODRUGS, METHODS OF MAKING AND USE THEREOF
South Korea	102038260
European Patent Office	3560336	ACIDE BENZOÏQUE, DÉRIVÉS D'ACIDE BENZOÏQUE ET CONJUGUÉS D'ACIDE CARBOXYLIQUE HÉTÉROARYLE D'HYDROCODONE, PROMÉDICAMENTS, PROCÉDÉS DE FABRICATION ET D'UTILISATION (BENZOIC ACID, BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE, PRODRUGS, METHODS OF MAKING AND USE THEREOF)
South Korea	20170124638	히드로코돈의 벤조산, 벤조산 유도체 및 헤테로아릴 카르복실산 콘쥬게이트, 이의 전구약물, 제조 방법 및 용도 (BENZOIC ACID BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE PRODRUGS METHODS OF MAKING AND USE THEREOF)