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Last Updated: April 25, 2024

Dextromethorphan hydrobromide; quinidine sulfate - Generic Drug Details

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What are the generic sources for dextromethorphan hydrobromide; quinidine sulfate and what is the scope of freedom to operate?

Dextromethorphan hydrobromide; quinidine sulfate is the generic ingredient in two branded drugs marketed by Actavis Elizabeth and Avanir Pharms, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dextromethorphan hydrobromide; quinidine sulfate has seventy-five patent family members in twenty-one countries.

Two suppliers are listed for this compound.

Summary for dextromethorphan hydrobromide; quinidine sulfate

International Patents:	75
US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Clinical Trials:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dextromethorphan hydrobromide; quinidine sulfate
DailyMed Link:	dextromethorphan hydrobromide; quinidine sulfate at DailyMed

Recent Clinical Trials for dextromethorphan hydrobromide; quinidine sulfate

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

Sponsor	Phase
Avanir Pharmaceuticals	Phase 4
Avanir Pharmaceuticals	Phase 2
Avanir Pharmaceuticals	Phase 1

See all dextromethorphan hydrobromide; quinidine sulfate clinical trials

Pharmacology for dextromethorphan hydrobromide; quinidine sulfate

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

Anatomical Therapeutic Chemical (ATC) Classes for dextromethorphan hydrobromide; quinidine sulfate

C01BA	Antiarrhythmics, class Ia
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

Paragraph IV (Patent) Challenges for DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

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 dextromethorphan hydrobromide; quinidine sulfate

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Glossary

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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
Actavis Elizabeth	DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	202934-001	Oct 10, 2017	AB	RX	No	No	⤷ 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 dextromethorphan hydrobromide; quinidine sulfate

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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 dextromethorphan hydrobromide; quinidine sulfate

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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 dextromethorphan hydrobromide; quinidine sulfate

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Country	Patent Number	Title	Estimated Expiration
Israel	267381		⤷ Try a Trial
Denmark	1980252		⤷ Try a Trial
Australia	2017202884	Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders	⤷ Try a Trial
Japan	2018150368	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
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for dextromethorphan hydrobromide; quinidine sulfate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	92323	Luxembourg	⤷ Try a Trial	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	C20130030 00105	Estonia	⤷ Try a Trial	PRODUCT NAME: DEKSTROMETORFAAN / KINIDIIN;REG NO/DATE: K(2013)4096 (LOPLIK) 26.06.2013
1539166	60/2013	Austria	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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