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Generated: December 13, 2018

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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 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-four patent family members in twenty-one countries.

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

US Patents and Regulatory Information 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 Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879-001 Oct 29, 2010 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Avanir Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879-001 Oct 29, 2010 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Actavis Elizabeth DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 202934-001 Oct 10, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for dextromethorphan hydrobromide; quinidine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Avanir Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879-001 Oct 29, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Avanir Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879-001 Oct 29, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Avanir Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879-001 Oct 29, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for dextromethorphan hydrobromide; quinidine sulfate

Country Document Number Estimated Expiration
Denmark 1980252 ➤ Try a Free Trial
South Korea 20130041296 ➤ Try a Free Trial
Slovenia 1980252 ➤ Try a Free Trial
Japan 2016106150 ➤ Try a Free Trial
Japan 6097859 ➤ Try a Free Trial
Japan 5082032 ➤ Try a Free Trial
Hong Kong 1076052 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for dextromethorphan hydrobromide; quinidine sulfate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90056-8 Sweden ➤ Try a Free Trial PRODUCT 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
323 Luxembourg ➤ Try a Free Trial PRODUCT 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
C0062 France ➤ Try a Free Trial PRODUCT 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 00059 Denmark ➤ Try a Free Trial PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
13/055 Ireland ➤ Try a Free Trial PRODUCT 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
/2013 Austria ➤ Try a Free Trial PRODUCT 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
0130030 00105 Estonia ➤ Try a Free Trial PRODUCT NAME: DEKSTROMETORFAAN / KINIDIIN;REG NO/DATE: K(2013)4096 (LOPLIK) 26.06.2013
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Julphar
Dow
Deloitte
Johnson and Johnson
Teva
Moodys
Baxter
Citi

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