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Last Updated: May 26, 2022

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*:
Constraining patent/regulatory exclusivity:
NDA:
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 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

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

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

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

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

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.

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

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Moodys
Merck
McKinsey
Medtronic
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.