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Serving leading biopharmaceutical companies globally:

McKesson
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Accenture
Healthtrust
UBS
Queensland Health
Cipla
Johnson and Johnson
Colorcon
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Generated: December 18, 2017

DrugPatentWatch Database Preview

Dextromethorphan hydrobromide; quinidine sulfate - Generic Drug Details

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What are the generic drug sources for dextromethorphan hydrobromide; quinidine sulfate and what is the scope of dextromethorphan hydrobromide; quinidine sulfate patent protection?

Dextromethorphan hydrobromide; quinidine sulfate
is the generic ingredient in two branded drugs marketed by Actavis Elizabeth and Avanir Pharms, and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dextromethorphan hydrobromide; quinidine sulfate has sixty-one patent family members in twenty-one countries and eleven supplementary protection certificates in ten countries.

There are twenty-two drug master file entries for dextromethorphan hydrobromide; quinidine sulfate. One supplier is listed for this compound.

Summary for dextromethorphan hydrobromide; quinidine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Avanir PharmsNUEDEXTAdextromethorphan hydrobromide; quinidine sulfateCAPSULE;ORAL021879-001Oct 29, 2010ABRXYesYes► Subscribe► Subscribe► Subscribe
Avanir PharmsNUEDEXTAdextromethorphan hydrobromide; quinidine sulfateCAPSULE;ORAL021879-001Oct 29, 2010ABRXYesYes► Subscribe► Subscribe► Subscribe
Actavis ElizabethDEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATEdextromethorphan hydrobromide; quinidine sulfateCAPSULE;ORAL202934-001Oct 10, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: dextromethorphan hydrobromide; quinidine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Avanir PharmsNUEDEXTAdextromethorphan hydrobromide; quinidine sulfateCAPSULE;ORAL021879-001Oct 29, 2010► Subscribe► Subscribe
Avanir PharmsNUEDEXTAdextromethorphan hydrobromide; quinidine sulfateCAPSULE;ORAL021879-001Oct 29, 2010► Subscribe► Subscribe
Avanir PharmsNUEDEXTAdextromethorphan hydrobromide; quinidine sulfateCAPSULE;ORAL021879-001Oct 29, 2010► Subscribe► Subscribe
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International Patent Family for Ingredient: dextromethorphan hydrobromide; quinidine sulfate

Country Document Number Estimated Expiration
Hong Kong1076052► Subscribe
Japan2017088620► Subscribe
Japan2014129384► Subscribe
Australia2003251971► Subscribe
World Intellectual Property Organization (WIPO)2004006930► Subscribe
Denmark1539166► Subscribe
Israel225191► Subscribe
South Korea20160055963► Subscribe
Canada2492081► Subscribe
Australia2013202187► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2013Austria► SubscribePRODUCT NAME: KOMBINATION VON A) DEXTROMETHORPHAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE DEXTROMETHORPHANHYDROBROMID, UND INSBESONDERE DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT UND B) CHINIDIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE CHINIDINSULFAT, UND INSBESONDERE CHINIDINSULFATDIHYDRAT.; REGISTRATION NO/DATE: EU/1/13/833 20130626
2013 00059Denmark► SubscribePRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
0130030 00105Estonia► SubscribePRODUCT NAME: DEKSTROMETORFAAN / KINIDIIN;REG NO/DATE: K(2013)4096 (LOPLIK) 26.06.2013
1Finland► Subscribe
13/055Ireland► SubscribePRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. QUINIDINE SULPHATE AND IN PARTICULAR QUINIDINE SULPHATE DIHYDRATE, PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/833 20130624
C0062France► SubscribePRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
2013 00059Denmark► SubscribePRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
90056-8Sweden► SubscribePRODUCT NAME: KOMBINATION AV (A) DEXTROMETORFAN ELLER ETT FARMACEUTISKT GODTAGBART SALT, PREKURSOR ELLER DERIVAT DAERAV, TEX. DEXTROMETORFAN-HYDROBROMID OCH I SYNNERHET DEXTROMETORFAN- HYDROBROMID MONOHYDRAT OCH (B) KINIDIN ELLER ETT FARMACEUTISKT GODTAGBART SALT, PREKURSOR ELLER DERIVAT DAERAV, TEX. KINIDINSULFAT OCH I SYNNERHET KINIDINSULFAT DIHYDRAT; REG. NO/DATE: EU/1/13/833 20130626
323Luxembourg► SubscribePRODUCT NAME: LA COMBINAISON DE (A) DEXTROMETHORPHAN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, PRECURSEURS OU DERIVES , PAR EX. HYDROBROMURE DE DEXTROMETHORPHAN ET EN PARTICULIER HYDROBROMURE DE DEXTROMETHORPHAN MONOHYDRATE; ET(B) QUINIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES , PRECURSEURS OU DERIVES, PAR EX. SULFATE DE QUINIDINE ET EN PARTICULIER SULFATE DE QUINIDINE DEHYDRATE; FIRST REGISTRATION: 20130624
8 5023-2013Slovakia► SubscribePRODUCT NAME: MONOHYDRAT DEXTROMETORFANU HYDROBROMIDU/- DIHYDRAT CHINIDINSULFATU; REGISTRATION NO/DATE: EU/1/13/833 20130624
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Serving leading biopharmaceutical companies globally:

Novartis
Colorcon
Julphar
Cipla
Covington
Deloitte
Farmers Insurance
Accenture
Harvard Business School
Chinese Patent Office

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 verifification 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.

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