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Last Updated: October 27, 2020

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NUEDEXTA Drug Profile

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When do Nuedexta patents expire, and when can generic versions of Nuedexta launch?

Nuedexta is a drug marketed by Avanir Pharms and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-two patent family members in twenty-one countries.

The generic ingredient in NUEDEXTA is dextromethorphan hydrobromide; quinidine sulfate. There are twenty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dextromethorphan hydrobromide; quinidine sulfate profile page.

US ANDA Litigation and Generic Entry Outlook for Nuedexta

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for NUEDEXTA
Drug Prices for NUEDEXTA

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Recent Clinical Trials for NUEDEXTA

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SponsorPhase
Holy Cross Hospital, FloridaPhase 1/Phase 2
The University of Texas Health Science Center, HoustonPhase 3
University of FloridaPhase 1/Phase 2

See all NUEDEXTA clinical trials

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

US Patents and Regulatory Information for NUEDEXTA

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   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 NUEDEXTA

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 NUEDEXTA

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 C300626 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN: (A) DEXTROMETHORFAN, DESGEWENST; 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 C20130030 00105 Estonia   Start Trial PRODUCT NAME: DEKSTROMETORFAAN / KINIDIIN;REG NO/DATE: K(2013)4096 (LOPLIK) 26.06.2013
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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