Claim Your New User Special: Get your second month free ▶ Second Month Free

Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Johnson and Johnson
Colorcon
Moodys
Boehringer Ingelheim

Last Updated: May 19, 2022

NUEDEXTA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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-five 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.

Drug patent expirations by year for NUEDEXTA
Drug Prices for NUEDEXTA

See drug prices for NUEDEXTA

Recent Clinical Trials for NUEDEXTA

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

SponsorPhase
All India Institute of Medical Sciences, BhubaneswarPhase 4
The University of Texas Health Science Center, HoustonPhase 3
Cures Within ReachPhase 3

See all NUEDEXTA clinical trials

Paragraph IV (Patent) Challenges for NUEDEXTA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NUEDEXTA Capsules dextromethorphan hydrobromide; quinidine sulfate 20 mg/10 mg 021879 1 2011-03-07

US Patents and Regulatory Information for NUEDEXTA

NUEDEXTA is protected by two US patents.

Patents protecting NUEDEXTA

Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PSEUDOBULBAR AFFECT

Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PSEUDOBULBAR AFFECT

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Avanir Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879-001 Oct 29, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Avanir Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879-001 Oct 29, 2010 See Plans and Pricing See Plans and Pricing
Avanir Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 021879-001 Oct 29, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for NUEDEXTA

When does loss-of-exclusivity occur for NUEDEXTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 03251971
Estimated Expiration: See Plans and Pricing

Patent: 08201775
Estimated Expiration: See Plans and Pricing

Patent: 10212348
Estimated Expiration: See Plans and Pricing

Patent: 13202184
Estimated Expiration: See Plans and Pricing

Patent: 13202187
Estimated Expiration: See Plans and Pricing

Patent: 15203262
Estimated Expiration: See Plans and Pricing

Patent: 17202884
Estimated Expiration: See Plans and Pricing

Patent: 19200415
Estimated Expiration: See Plans and Pricing

Patent: 20270454
Estimated Expiration: See Plans and Pricing

Austria

Patent: 9553
Estimated Expiration: See Plans and Pricing

Canada

Patent: 92081
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17102
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 39166
Estimated Expiration: See Plans and Pricing

Patent: 80252
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 39166
Estimated Expiration: See Plans and Pricing

Patent: 80252
Estimated Expiration: See Plans and Pricing

Patent: 22179
Estimated Expiration: See Plans and Pricing

Patent: 81630
Estimated Expiration: See Plans and Pricing

Patent: 59547
Estimated Expiration: See Plans and Pricing

Patent: 24889
Estimated Expiration: See Plans and Pricing

Germany

Patent: 321929
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 76052
Estimated Expiration: See Plans and Pricing

Patent: 23741
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 28100
Estimated Expiration: See Plans and Pricing

Patent: 300069
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6166
Estimated Expiration: See Plans and Pricing

Patent: 1593
Estimated Expiration: See Plans and Pricing

Patent: 5190
Estimated Expiration: See Plans and Pricing

Patent: 5191
Estimated Expiration: See Plans and Pricing

Patent: 5192
Estimated Expiration: See Plans and Pricing

Patent: 6054
Estimated Expiration: See Plans and Pricing

Patent: 7381
Estimated Expiration: See Plans and Pricing

Japan

Patent: 82032
Estimated Expiration: See Plans and Pricing

Patent: 74000
Estimated Expiration: See Plans and Pricing

Patent: 97859
Estimated Expiration: See Plans and Pricing

Patent: 32651
Estimated Expiration: See Plans and Pricing

Patent: 05537268
Estimated Expiration: See Plans and Pricing

Patent: 11225601
Estimated Expiration: See Plans and Pricing

Patent: 12116858
Estimated Expiration: See Plans and Pricing

Patent: 14058575
Estimated Expiration: See Plans and Pricing

Patent: 14129384
Estimated Expiration: See Plans and Pricing

Patent: 16011304
Estimated Expiration: See Plans and Pricing

Patent: 16106150
Estimated Expiration: See Plans and Pricing

Patent: 17036337
Estimated Expiration: See Plans and Pricing

Patent: 17088620
Estimated Expiration: See Plans and Pricing

Patent: 18150368
Estimated Expiration: See Plans and Pricing

Patent: 20063248
Estimated Expiration: See Plans and Pricing

Patent: 21098743
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 323
Estimated Expiration: See Plans and Pricing

Norway

Patent: 0626
Estimated Expiration: See Plans and Pricing

Patent: 13017
Estimated Expiration: See Plans and Pricing

Patent: 050807
Estimated Expiration: See Plans and Pricing

Poland

Patent: 3552
Estimated Expiration: See Plans and Pricing

Patent: 4026
Estimated Expiration: See Plans and Pricing

Patent: 8445
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 39166
Estimated Expiration: See Plans and Pricing

Patent: 80252
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 41265
Estimated Expiration: See Plans and Pricing

Patent: 05104418
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 39166
Estimated Expiration: See Plans and Pricing

Patent: 80252
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1588095
Estimated Expiration: See Plans and Pricing

Patent: 1622446
Estimated Expiration: See Plans and Pricing

Patent: 050043893
Estimated Expiration: See Plans and Pricing

Patent: 110010669
Estimated Expiration: See Plans and Pricing

Patent: 120089706
Estimated Expiration: See Plans and Pricing

Patent: 130041296
Estimated Expiration: See Plans and Pricing

Patent: 130043217
Estimated Expiration: See Plans and Pricing

Patent: 160055963
Estimated Expiration: See Plans and Pricing

Patent: 190143466
Estimated Expiration: See Plans and Pricing

Spain

Patent: 09351
Estimated Expiration: See Plans and Pricing

Patent: 53654
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 26214
Estimated Expiration: See Plans and Pricing

Patent: 0403997
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering NUEDEXTA around the world.

Country Patent Number Title Estimated Expiration
Israel 256054 See Plans and Pricing
Norway 2013017 See Plans and Pricing
Australia 2013202184 Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders - D2 See Plans and Pricing
Japan 2016106150 神経疾患治療のためのデキストロメトルファンおよびキニジンを含む薬剤組成物 (PHARMACEUTICAL COMPOSITIONS COMPRISING DEXTROMETHORPHAN AND QUINIDINE FOR TREATMENT OF NEUROLOGICAL DISORDERS) See Plans and Pricing
Slovenia 1980252 See Plans and Pricing
Hong Kong 1076052 Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NUEDEXTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1539166 C 2013 034 Romania See Plans and Pricing PRODUCT NAME: COMBINATIE A DEXTROMETORFANULUI SAU A UNEI SARIACCEPTABILE FARMACEUTIC, DE EXEMPLU DEXNATIONAL AUTHORISATION NUMBER: EU/1/13/833/001, EU/1/13/833/002, EU/1/13/833/003; DATE OF NATIONAL AUTHORISATION: 20130624; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/833/001, EU/1/13/833/002, EU/1/13/833/003; DATE OF FIRST AUTHORISATION IN EEA: 20130624 TROMETORFAN BROMHIDRAT SI PARTICULAR DEXTROMETORFAN BROMHIDRATMONOHIDRAT SI CHINIDINA SAU O SARE ACCEPTABILA FARMACEUTIC, DE EXEMPLU SULFAT DE CHINIDINA SI IN PAR TICULAR SULFATDE CHINIDINA DIHIDRAT;
1539166 CA 2013 00059 Denmark See Plans and Pricing PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
1539166 92323 Luxembourg See Plans and Pricing 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
1539166 CR 2013 00059 Denmark See Plans and Pricing PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
1539166 2013/055 Ireland See Plans and Pricing 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
1539166 122013000090 Germany See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Medtronic
Colorcon
Dow
AstraZeneca

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 verification 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.