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NUEDEXTA Drug Patent Profile

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 is one patent 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 10^th, 2017.

Summary for NUEDEXTA

International Patents:	75
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
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

See drug prices for NUEDEXTA

Recent Clinical Trials for NUEDEXTA

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

Sponsor	Phase
All India Institute of Medical Sciences, Bhubaneswar	Phase 4
Cures Within Reach	Phase 3
The University of Texas Health Science Center, Houston	Phase 3

See all NUEDEXTA clinical trials

Pharmacology for NUEDEXTA

Drug Class	Antiarrhythmic Cytochrome P450 2D6 Inhibitor Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists

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 one US patents.

Patents protecting NUEDEXTA

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

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
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010

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

International Patents for NUEDEXTA

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

Country	Patent Number	Title	Estimated Expiration
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)
Australia	2003251971	PHARMACEUTICAL COMPOSITIONS COMPRISING DEXTROMETHORPHAN AND QUINIDINE FOR THE TREATMENT OF NEUROLOGICAL DISORDERS
South Korea	20130041296	PHARMACEUTICAL COMPOSITION COMPRISING DEXTROMETHORPHAN AND QUINIDINE FOR THE TREATMENT OF NEUROLOGICAL DISORDERS

Supplementary Protection Certificates for NUEDEXTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539166	60/2013	Austria		PRODUCT 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
1539166	451	Finland
1539166	122013000090	Germany		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