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 Kvk Tech Inc 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
What excipients (inactive ingredients) are in APADAZ?	APADAZ excipients list
DailyMed Link:	APADAZ at DailyMed

Drug patent expirations by year for APADAZ

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for APADAZ

Generic Entry Date for APADAZ^: See Plans and Pricing* Constraining patent/regulatory exclusivity: See Plans and Pricing 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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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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
Kvk Tech Inc	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-002	Jan 4, 2019		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Kvk Tech Inc	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-001	Feb 23, 2018		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Kvk Tech Inc	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-002	Jan 4, 2019		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Kvk Tech Inc	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-003	Jan 4, 2019		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
>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: See Plans and Pricing

Brazil

Patent: 2012000569
Estimated Expiration: See Plans and Pricing

Canada

Patent: 66388
Estimated Expiration: See Plans and Pricing

Chile

Patent: 11003347
Estimated Expiration: See Plans and Pricing

China

Patent: 2480959
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 80991
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 110688
Estimated Expiration: See Plans and Pricing

Cuba

Patent: 128
Estimated Expiration: See Plans and Pricing

Patent: 110246
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 48407
Estimated Expiration: See Plans and Pricing

Patent: 60336
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7096
Estimated Expiration: See Plans and Pricing

Patent: 9889
Estimated Expiration: See Plans and Pricing

Japan

Patent: 42862
Estimated Expiration: See Plans and Pricing

Patent: 12532142
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 3046
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 12000128
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 7235
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 05541
Estimated Expiration: See Plans and Pricing

Patent: 12103476
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 7445
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1109438
Estimated Expiration: See Plans and Pricing

Patent: 1300747
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1655972
Estimated Expiration: See Plans and Pricing

Patent: 1795330
Estimated Expiration: See Plans and Pricing

Patent: 1877467
Estimated Expiration: See Plans and Pricing

Patent: 1971223
Estimated Expiration: See Plans and Pricing

Patent: 2038260
Estimated Expiration: See Plans and Pricing

Patent: 120048589
Estimated Expiration: See Plans and Pricing

Patent: 160106781
Estimated Expiration: See Plans and Pricing

Patent: 170124638
Estimated Expiration: See Plans and Pricing

Patent: 180081176
Estimated Expiration: See Plans and Pricing

Patent: 190042115
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 2916
Estimated Expiration: See Plans and Pricing

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	101971223		See Plans and Pricing
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)	See Plans and Pricing
South Korea	101877467		See Plans and Pricing
Israel	259889		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration