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Dextromethorphan hydrobromide; quinidine sulfate - Generic Drug Details

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

This ingredient has fifty-five patent family members in nineteen 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:3
Applicants:1
NDAs:1
Drug Master File Entries: see list22
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 2010RXYes8,227,484► subscribe ► subscribe
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 2010RXYesRE38115► subscribeYY ► subscribe
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 2010RXYes7,659,282► 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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Non-Orange Book Patents for Generic Ingredient: dextromethorphan hydrobromide; quinidine sulfate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,863,927 Dextromethorphan and an oxidase inhibitor for treating intractable conditions► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: dextromethorphan hydrobromide; quinidine sulfate

Country Document Number Estimated Expiration
Hong Kong1123741► subscribe
European Patent Office0788359► subscribe
Japan2016011304► 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
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 ET 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
2013 00059Denmark► subscribePRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
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