Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

How our clients use DrugPatentWatch

DrugPatentWatch Database Preview

NUEDEXTA Drug Profile

« Back to Dashboard

Which patents cover Nuedexta, and what substitute generic drugs are available?

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 forty-nine patent family members in twenty 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.

Summary for Tradename: NUEDEXTA

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list5
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:NUEDEXTA at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 2010RXYesYes7,659,282► Subscribe ► Subscribe
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 2010RXYesYes8,227,484► Subscribe ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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, 20105,166,207► Subscribe
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 20105,206,248► Subscribe
Avanir Pharms
NUEDEXTA
dextromethorphan hydrobromide; quinidine sulfate
CAPSULE;ORAL021879-001Oct 29, 2010RE38115► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV activity 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
Japan2016106150► Subscribe
South Korea20120089706► Subscribe
Israel225191► Subscribe
World Intellectual Property Organization (WIPO)2004006930► Subscribe
Norway20050807► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: NUEDEXTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/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
00626Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN: (A) DEXTROMETHORFAN, DESGEWENST; REGISTRATION NO/DATE: EU/1/13/833 20130624
1Finland► Subscribe
323Luxembourg► SubscribePRODUCT 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
0130030 00105Estonia► SubscribePRODUCT NAME: DEKSTROMETORFAAN / KINIDIIN;REG NO/DATE: K(2013)4096 (LOPLIK) 26.06.2013
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How our clients use DrugPatentWatch

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.

`abc