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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 one branded drug marketed by Avanir Pharms and is included in one NDA. 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 fifty-five patent family members in twenty-one countries.

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

Summary for Generic Name: dextromethorphan hydrobromide; quinidine sulfate

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: see list22
Suppliers / Packagers: see list1
Clinical Trials: see list803
Drug Prices:see low prices
DailyMed Link:dextromethorphan hydrobromide; quinidine sulfate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 2010RXYesYes8,227,484► Subscribe ► Subscribe
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 2010RXYesYes7,659,282► 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 Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 20105,166,207► Subscribe
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 2010RE38115► Subscribe
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 20105,206,248► Subscribe
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International Patent Family for Ingredient: dextromethorphan hydrobromide; quinidine sulfate

Country Document Number Estimated Expiration
Australia2013202187► Subscribe
Japan5082032► Subscribe
Germany60321929► Subscribe
Japan2014129384► Subscribe
Russian Federation2005104418► 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
8 5023-2013Slovakia► SubscribePRODUCT NAME: MONOHYDRAT DEXTROMETORFANU HYDROBROMIDU/- DIHYDRAT CHINIDINSULFATU; REGISTRATION NO/DATE: EU/1/13/833 20130624
2013 00059Denmark► SubscribePRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
00626Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN: (A) DEXTROMETHORFAN, DESGEWENST; 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chubb
McKesson
Deloitte
Cerilliant
Healthtrust
Chinese Patent Office
Queensland Health
Boehringer Ingelheim
UBS
Accenture

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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