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. One supplier is listed 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Formulation / Manufacturing:	see details
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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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.

Anatomical Therapeutic Chemical (ATC) Classes for APADAZ

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 APADAZ

APADAZ is protected by six US patents.

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

This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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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	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-001	Feb 23, 2018		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-002	Jan 4, 2019		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
>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
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 2012000569
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 66388
Estimated Expiration: ⤷ Try a Trial

Chile

Patent: 11003347
Estimated Expiration: ⤷ Try a Trial

China

Patent: 2480959
Estimated Expiration: ⤷ Try a Trial

Colombia

Patent: 80991
Estimated Expiration: ⤷ Try a Trial

Costa Rica

Patent: 110688
Estimated Expiration: ⤷ Try a Trial

Cuba

Patent: 128
Estimated Expiration: ⤷ Try a Trial

Patent: 110246
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 48407
Estimated Expiration: ⤷ Try a Trial

Patent: 60336
Estimated Expiration: ⤷ Try a Trial

Israel

Patent: 7096
Estimated Expiration: ⤷ Try a Trial

Patent: 9889
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 42862
Estimated Expiration: ⤷ Try a Trial

Patent: 12532142
Estimated Expiration: ⤷ Try a Trial

Malaysia

Patent: 3046
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 12000128
Estimated Expiration: ⤷ Try a Trial

New Zealand

Patent: 7235
Estimated Expiration: ⤷ Try a Trial

Russian Federation

Patent: 05541
Estimated Expiration: ⤷ Try a Trial

Patent: 12103476
Estimated Expiration: ⤷ Try a Trial

Singapore

Patent: 7445
Estimated Expiration: ⤷ Try a Trial

South Africa

Patent: 1109438
Estimated Expiration: ⤷ Try a Trial

Patent: 1300747
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 1655972
Estimated Expiration: ⤷ Try a Trial

Patent: 1795330
Estimated Expiration: ⤷ Try a Trial

Patent: 1877467
Estimated Expiration: ⤷ Try a Trial

Patent: 1971223
Estimated Expiration: ⤷ Try a Trial

Patent: 2038260
Estimated Expiration: ⤷ Try a Trial

Patent: 120048589
Estimated Expiration: ⤷ Try a Trial

Patent: 160106781
Estimated Expiration: ⤷ Try a Trial

Patent: 170124638
Estimated Expiration: ⤷ Try a Trial

Patent: 180081176
Estimated Expiration: ⤷ Try a Trial

Patent: 190042115
Estimated Expiration: ⤷ Try a Trial

Ukraine

Patent: 2916
Estimated Expiration: ⤷ Try a Trial

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.

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Country	Patent Number	Title	Estimated Expiration
South Korea	20180081176	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)	⤷ Try a Trial
South Korea	20190042115	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)	⤷ Try a Trial
Israel	217096	תכשירים הכוללים תצמידים של בנזואט הידרוקודון ושימושים בהם (Compositions comprising conjugates of benzoate hydrocodone and use thereof)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration