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Serving leading biopharmaceutical companies globally:

AstraZeneca
Farmers Insurance
Cerilliant
Covington
Federal Trade Commission
Dow
UBS
Daiichi Sankyo
Queensland Health
McKinsey

Generated: November 19, 2017

DrugPatentWatch Database Preview

NUEDEXTA Drug Profile

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What is the patent landscape for Nuedexta, 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 sixty-three patent family members in twenty-one countries and eleven supplementary protection certificates in ten countries.

The generic ingredient in NUEDEXTA is dextromethorphan hydrobromide; quinidine sulfate. There are twenty-two 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.
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, 2010ABRXYesYes► Subscribe► Subscribe ► Subscribe
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 2010ABRXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Patents for Tradename: NUEDEXTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 2010► Subscribe► Subscribe
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 2010► Subscribe► Subscribe
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 2010► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for NUEDEXTA

Drugname Dosage Strength RLD Submissiondate
dextromethorphan hydrobromide and quinidine sulfateCapsules20 mg/10 mgNuedexta3/7/2011

International Patent Family for Tradename: NUEDEXTA

Country Document Number Estimated Expiration
Australia2017202884► Subscribe
Japan2014058575► Subscribe
Russian Federation2005104418► Subscribe
Australia2015203262► Subscribe
South Korea20110010669► Subscribe
Poland374026► Subscribe
European Patent Office1539166► Subscribe
Japan2017088620► Subscribe
Japan6097859► Subscribe
Austria399553► 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: NUEDEXTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0130030 00105Estonia► SubscribePRODUCT NAME: DEKSTROMETORFAAN / KINIDIIN;REG NO/DATE: K(2013)4096 (LOPLIK) 26.06.2013
2013 00059Denmark► SubscribePRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. 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
/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
13/055Ireland► SubscribePRODUCT 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
90056-8Sweden► SubscribePRODUCT 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
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
1Finland► Subscribe
00626Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN: (A) DEXTROMETHORFAN, DESGEWENST; REGISTRATION NO/DATE: EU/1/13/833 20130624
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Argus Health
Novartis
Johnson and Johnson
Queensland Health
Julphar
Moodys
Farmers Insurance
Cerilliant
Express Scripts
Baxter

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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