APADAZ Drug Patent Profile

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When do Apadaz patents expire, and what generic alternatives are available?

Apadaz is a drug marketed by Zevra Therap and is included in one NDA. There are five patents protecting this drug.

This drug has thirty-five patent family members in twenty countries.

The generic ingredient in APADAZ is acetaminophen; benzhydrocodone hydrochloride. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; benzhydrocodone hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Apadaz

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 22, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for APADAZ

International Patents:	35
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Drug Prices:	Drug price information for APADAZ
What excipients (inactive ingredients) are in APADAZ?	APADAZ excipients list
DailyMed Link:	APADAZ at DailyMed

Drug patent expirations by year for APADAZ

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for APADAZ

Generic Entry Date for APADAZ^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 208653 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.

US Patents and Regulatory Information for APADAZ

APADAZ is protected by six US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of APADAZ is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting APADAZ

Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF ACUTE PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE

Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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Glossary

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

International Patents for APADAZ

When does loss-of-exclusivity occur for APADAZ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 10266205
Patent: Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2012000569
Patent: ácido benzóico, derivados de ácido benzóico e conjugados de ácido heteroaril carboxílico de hidrocodona, pró-farmacos, métodos de produção e uso destes
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 66388
Patent: 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)
Estimated Expiration: ⤷ Sign Up

Chile

Patent: 11003347
Patent: 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.
Estimated Expiration: ⤷ Sign Up

China

Patent: 2480959
Patent: Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Estimated Expiration: ⤷ Sign Up

Colombia

Patent: 80991
Patent: ACIDO BENZOICO, DERIVADOS DE ACIDO BENZOICO Y CONJUGADOS DE ACIDO HETEROARIL CARBOXILICO DE HIDROCODONA, PROFARMACOS, METODOS PARA ELABORAR Y UTILIZAR LOS MISMOS
Estimated Expiration: ⤷ Sign Up

Costa Rica

Patent: 110688
Patent: CONJUGADOS DE HIDROCODONA CON ÁCIDO BENZOICO, DERIVADOS DE ÁCIDO BENZOICO Y ÁCIDO CARBOXÍLICO HETEROARÍLICO, PROFÁRCOS, MÉTODOS DE PREPARACIÓN Y USO DE LOS MISMOS
Estimated Expiration: ⤷ Sign Up

Cuba

Patent: 128
Patent: COMPUESTO DE BENZOATO CONJUGADO A LA HIDROCODONA (BZ-HC)
Estimated Expiration: ⤷ Sign Up

Patent: 110246
Patent: ÁCIDO BENZOICO, DERIVADOS DE ÁCIDO BENZOICO Y CONJUGADOS DE ÁCIDO HETEROARIL CARBOXÍLICO DE HIDROCODONA, PROFÁRMACOS, MÉTODOS PARA ELABORAR Y UTILIZAR LOS MISMOS
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 48407
Patent: ACIDE BENZOÏQUE, DÉRIVÉS D'ACIDE BENZOÏQUE ET CONJUGUÉS D'ACIDEHÉTÉROARYLCARBOXYLIQUEE D'HYDROCODONE, PROMÉDICAMENTS, LEURS 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)
Estimated Expiration: ⤷ Sign Up

Patent: 60336
Patent: 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)
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 7096
Patent: תכשירים הכוללים תצמידים של בנזואט הידרוקודון ושימושים בהם (Compositions comprising conjugates of benzoate hydrocodone and use thereof)
Estimated Expiration: ⤷ Sign Up

Patent: 9889
Patent: תצמידי חומצה בנזואית, תולדות חומצה בנזואית וחומצה קרבוקסילית הטרוארילית של הידרוקודון, מטרימי תרופות, שיטות להכנתם ושימוש בהם (Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 42862
Estimated Expiration: ⤷ Sign Up

Patent: 12532142
Estimated Expiration: ⤷ Sign Up

Malaysia

Patent: 3046
Patent: BENZOIC ACID, BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE, PRODRUGS, METHODS OF MAKING AND USE THEREOF
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 12000128
Patent: ACIDO BENZOICO, DERIVADOS DE ACIDO BENZOICO Y CONJUGADOS DE ACIDO HETEROARIL CARBOXILICO DE HIDROCODONA, PROFARMACOS METODOS PARA ELABORALOS Y SUS USOS. (BENZOIC ACID, BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE, PRODRUGS, METHODS OF MAKING AND USE THEREOF.)
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 7235
Patent: BENZOIC ACID, BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE, PRODRUGS, METHODS OF MAKING AND USE THEREOF
Estimated Expiration: ⤷ Sign Up

Russian Federation

Patent: 05541
Patent: КОНЪЮГАТЫ ГИДРОКОДОНА С БЕНЗОЙНОЙ КИСЛОТОЙ, ПРОИЗВОДНЫМИ БЕНЗОЙНОЙ КИСЛОТЫ И ГЕТЕРОАРИЛКАРБОНОВОЙ КИСЛОТОЙ, ПРОЛЕКАРСТВА, СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ (CONJUGATES OF HYDROCODONE WITH BENZOIC ACID, DERIVATIVES OF BENZOIC ACID AND HETERO-ACRYL-CARBON ACID, PRODRUGS, METHODS FOR THEIR OBTAINING AND APPLICATION)
Estimated Expiration: ⤷ Sign Up

Patent: 12103476
Patent: КОНЪЮГАТЫ ГИДРОКОДОНА С БЕНЗОЙНОЙ КИСЛОТОЙ, ПРОИЗВОДНЫМИ БЕНЗОЙНОЙ КИСЛОТЫ И ГЕТЕРОАРИЛКАРБОНОВОЙ КИСЛОТОЙ, ПРОЛЕКАРСТВА, СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 7445
Patent: BENZOIC ACID, BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE, PRODRUGS, METHODS OF MAKING AND USE THEREOF
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 1109438
Patent: BENZOIC ACID,BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE,PRODRUGS,METHODS OF MAKING AND USE THEREOF
Estimated Expiration: ⤷ Sign Up

Patent: 1300747
Patent: BENZOIC ACID,BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE,PRODRUGS,METHODS OF MAKING AND USE THEREOF
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 1655972
Estimated Expiration: ⤷ Sign Up

Patent: 1795330
Estimated Expiration: ⤷ Sign Up

Patent: 1877467
Estimated Expiration: ⤷ Sign Up

Patent: 1971223
Estimated Expiration: ⤷ Sign Up

Patent: 2038260
Estimated Expiration: ⤷ Sign Up

Patent: 120048589
Patent: BENZOIC ACID, BENZOIC ACID DERIVATIVES AND HETEROARYL CARBOXYLIC ACID CONJUGATES OF HYDROCODONE, PRODRUGS, METHODS OF MAKING AND USE THEREOF
Estimated Expiration: ⤷ Sign Up

Patent: 160106781
Patent: 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)
Estimated Expiration: ⤷ Sign Up

Patent: 170124638
Patent: 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)
Estimated Expiration: ⤷ Sign Up

Patent: 180081176
Patent: 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)
Estimated Expiration: ⤷ Sign Up

Patent: 190042115
Patent: 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)
Estimated Expiration: ⤷ Sign Up

Ukraine

Patent: 2916
Patent: КОМПОЗИЦИЯ НА ОСНОВЕ КОНЬЮГАТА ГИДРОКОДОНА С БЕНЗОЛЬНОЙ КИСЛОТОЙ, ПРОИЗВОДНЫМИ БЕНЗОЙНОЙ КИСЛОТ ИЛИ ГЕТЕРОАРИЛКАРБОНОВОЙ КИСЛОТОЙ, ПРОЛЕКАРСТВА, СПОСОБ ЛЕЧЕНИЯ ОТ ЗЛОУПОТРЕБЛЕНИЙ;КОМПОЗИЦІЯ НА ОСНОВІ КОН'ЮГАТУ ГІДРОКОДОНУ З БЕНЗОЙНОЮ КИСЛОТОЮ, ПОХІДНИМИ БЕНЗОЙНОЇ КИСЛОТИ АБО ГЕТЕРОАРИЛКАРБОНОВОЮ КИСЛОТОЮ, ПРОЛІКИ, СПОСІБ ЛІКУВАННЯ ВІД ЗЛОВЖИВАНЬ (COMPOSITION BASED ON CONJUGATES OF HYDROCODONE WITH BENZOIC ACID, BENZOIC ACID OR HETEROARYL CARBOXYLIC ACID DERIVATIVES, PRODRUGS AND METHOD FOR TREATMENT OF ABUSES)
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering APADAZ around the world.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
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)	⤷ Sign Up
South Korea	101971223		⤷ Sign Up
South Korea	101795330		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration