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Last Updated: November 24, 2020

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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 freedom to operate?

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 seventy-two 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.

Recent Clinical Trials for dextromethorphan hydrobromide; quinidine sulfate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Avanir PharmaceuticalsPhase 4
Avanir PharmaceuticalsPhase 2
Avanir PharmaceuticalsPhase 1

See all dextromethorphan hydrobromide; quinidine sulfate clinical trials

Paragraph IV (Patent) Challenges for DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
Tradename Dosage Ingredient NDA Submissiondate
NUEDEXTA CAPSULE;ORAL dextromethorphan hydrobromide; quinidine sulfate 021879 2011-03-07

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

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

Supplementary Protection Certificates for dextromethorphan hydrobromide; quinidine sulfate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1539166 2013C/064 Belgium   Start Trial PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626
1539166 122013000090 Germany   Start Trial PRODUCT NAME: KOMBINATION AUS: (A) DEXTROMETHORPHAN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ, Z.B. DEXTROMETHORPHAN-HYDROBROMID UND INSBESONDERE DEXTROMETHORPHAN-HYDROBROMID-MONOHYDRAT; UND (B) CHINIDIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, Z.B.CHINIDIN-SULFAT UND INSBESONDERE CHINIDIN-SULFAT-DIHYDRAT; REGISTRATION NO/DATE: EU/1/13/833 20130624
1539166 132013902215214 Italy   Start Trial PRODUCT NAME: ASSOCIAZIONE DI (A) DESTROMETORFANO O UN SUO SALE, PRECURSORE O DERIVATO FARMACEUTICAMENTE ACCETTABILE, INCLUSO IL DESTROMETORFANO BROMIDRATO E IN PARTICOLARE IL DESTROMETORFANO BROMIDRATO MONOIDRATO E (B) CHINIDINA O UN SUO SALE,PRECURSORE O DERIVATO FARMACEUTICAMENTE ACCETTABILE, INCLUSA LA CHINIDINA SOLFATO E IN PARTICOLARE LA CHINIDINA SOLFATO DIIDRATO(NUEDEXTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/833, 20130626
1539166 SPC/GB13/070 United Kingdom   Start Trial PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. Q; REGISTERED: UK EU/1/13/833 20130626
1539166 C300626 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN: (A) DEXTROMETHORFAN, DESGEWENST; REGISTRATION NO/DATE: EU/1/13/833 20130624
1539166 451 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
Medtronic
AstraZeneca
Colorcon
Express Scripts

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