NUEDEXTA Drug Patent 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-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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nuedexta
A generic version of NUEDEXTA was approved as dextromethorphan hydrobromide; quinidine sulfate by ACTAVIS ELIZABETH on October 10th, 2017.
Summary for NUEDEXTA
International Patents: | 75 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 11 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for NUEDEXTA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NUEDEXTA |
What excipients (inactive ingredients) are in NUEDEXTA? | NUEDEXTA excipients list |
DailyMed Link: | NUEDEXTA at DailyMed |


Recent Clinical Trials for NUEDEXTA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
All India Institute of Medical Sciences, Bhubaneswar | Phase 4 |
The University of Texas Health Science Center, Houston | Phase 3 |
Cures Within Reach | Phase 3 |
Pharmacology for NUEDEXTA
Anatomical Therapeutic Chemical (ATC) Classes for NUEDEXTA
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 |