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Last Updated: March 5, 2024

Acetaminophen; benzhydrocodone hydrochloride - Generic Drug Details


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What are the generic drug sources for acetaminophen; benzhydrocodone hydrochloride and what is the scope of patent protection?

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
Generic Entry Date for acetaminophen; benzhydrocodone hydrochloride*:
Constraining patent/regulatory exclusivity:
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

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 ⤷  Try a Trial ⤷  Try a Trial Y 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
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 Y ⤷  Try a Trial
Zevra Therap APADAZ acetaminophen; benzhydrocodone hydrochloride TABLET;ORAL 208653-003 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 acetaminophen; benzhydrocodone hydrochloride

Country Patent Number Title Estimated Expiration
South Korea 101971223 ⤷  Try a Trial
Cuba 24128 COMPUESTO DE BENZOATO CONJUGADO A LA HIDROCODONA (BZ-HC) ⤷  Try a Trial
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) ⤷  Try a Trial
Australia 2010266205 Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof ⤷  Try a Trial
Russian Federation 2505541 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) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.