Dextromethorphan hydrobromide; quinidine sulfate - Generic Drug Details

What are the generic drug 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, Hetero Labs Ltd Iii, and Avanir Pharms, and is included in three 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:	3
NDAs:	3
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Elizabeth	DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	202934-001	Oct 10, 2017	AB	RX	No	No
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	AB	RX	Yes	Yes
Hetero Labs Ltd Iii	DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	218426-001	Aug 28, 2024	AB	RX	No	No

Expired US Patents for dextromethorphan hydrobromide; quinidine sulfate

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

EU/EMA Drug Approvals for dextromethorphan hydrobromide; quinidine sulfate

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 dextromethorphan hydrobromide; quinidine sulfate

Country	Patent Number	Title	Estimated Expiration
Hungary	S1300069
South Korea	20190143466	덱스트로메토르판 및 퀴니딘을 포함하는 신경계 장애의 치료를 위한 약학적 조성물 (Pharmaceutical composition comprising dextromethorphan and quinidine for the treatment of neurological disorders)
Japan	5082032
Russian Federation	2005104418	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ НЕВРОЛОГИЧЕСКИХ РАССТРОЙСТВ, СОДЕРЖАЩИЕ ДЕКСТРОМЕТОРФАН И КВИНИДИН
Japan	2012116858	PHARMACEUTICAL COMPOSITION COMPRISING DEXTROMETHORPHAN AND QUINIDINE FOR TREATMENT OF NEUROLOGICAL DISORDER

Supplementary Protection Certificates for dextromethorphan hydrobromide; quinidine sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539166	2013C/064	Belgium		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	C 2013 034	Romania		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	1390056-8	Sweden		PRODUCT NAME: KOMBINATION AV (A) DEXTROMETORFAN ELLER ETT FARMACEUTISKT GODTAGBART SALT, PREKURSOR ELLER DERIVAT DAERAV, TEX. DEXTROMETORFAN-HYDROBROMID OCH I SYNNERHET DEXTROMETORFAN- HYDROBROMID MONOHYDRAT OCH (B) KINIDIN ELLER ETT FARMACEUTISKT GODTAGBART SALT, PREKURSOR ELLER DERIVAT DAERAV, TEX. KINIDINSULFAT OCH I SYNNERHET KINIDINSULFAT DIHYDRAT; REG. NO/DATE: EU/1/13/833 20130626
1539166	C300626	Netherlands		PRODUCT NAME: COMBINATIE VAN: (A) DEXTROMETHORFAN, DESGEWENST; REGISTRATION NO/DATE: EU/1/13/833 20130624
1539166	132013902215214	Italy		PRODUCT NAME: ASSOCIAZIONE DI (A) DESTROMETORFANO O UN SUO SALE, PRECURSORE O DERIVATO FARMACEUTICAMENTE ACCETTABILE, INCLUSO IL DESTROMETORFANO BROMIDRATO E IN PARTICOLARE IL DESTROMETORFANO BROMIDRATO MONOIDRATO E (B) CHINIDINA O UN SUO SALE,PRECURSORE O DERIVATO FARMACEUTICAMENTE ACCETTABILE, INCLUSA LA CHINIDINA SOLFATO E IN PARTICOLARE LA CHINIDINA SOLFATO DIIDRATO(NUEDEXTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/833, 20130626