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. Two suppliers are 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: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 2 |
Clinical Trials: | 11 |
Patent Applications: | 72 |
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PSEUDOBULBAR AFFECT
Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Avanir Pharms | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Avanir Pharms | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Avanir Pharms | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Avanir Pharms | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for NUEDEXTA
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Jenson Pharmaceutical Services Limited | Nuedexta | dextromethorphan hydrobromide, quinidine sulfate | EMEA/H/C/002560 Nuedexta is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults. Efficacy has only been studied in patients with underlying amyotrophic lateral sclerosis or multiple sclerosis. |
Withdrawn | no | no | no | 2013-06-24 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for NUEDEXTA
See the table below for patents covering NUEDEXTA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 267381 | ⤷ Try a Trial | |
Canada | 2492081 | COMPOSITIONS PHARMACEUTIQUES COMPRENANT DU DEXTROMETHORPHAN ET DE LA QUINIDINE POUR TRAITER DES TROUBLES NEUROLOGIQUES (PHARMACEUTICAL COMPOSITIONS COMPRISING DEXTROMETHORPHAN AND QUINIDINE FOR THE TREATMENT OF NEUROLOGICAL DISORDERS) | ⤷ Try a Trial |
Australia | 2008201775 | Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders | ⤷ Try a Trial |
Japan | H10505864 | ⤷ Try a Trial | |
Japan | 2017036337 | 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) | ⤷ Try a Trial |
Denmark | 1980252 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NUEDEXTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1539166 | 451 | Finland | ⤷ Try a Trial | |
1539166 | 2013C/064 | Belgium | ⤷ Try a 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 | 198 5023-2013 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: MONOHYDRAT DEXTROMETORFANU HYDROBROMIDU/- DIHYDRAT CHINIDINSULFATU; REGISTRATION NO/DATE: EU/1/13/833 20130624 |
1539166 | 13C0062 | France | ⤷ Try a Trial | PRODUCT 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 |
1539166 | CR 2013 00059 | Denmark | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624 |
1539166 | CA 2013 00059 | Denmark | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |