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.

Three 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:	3
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	11
Patent Applications:	294
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
Hetero Labs Ltd Iii	DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	218426-001	Aug 28, 2024	AB	RX	No	No
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	AB	RX	Yes	Yes	7,659,282
Actavis Elizabeth	DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	202934-001	Oct 10, 2017	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	5,166,207
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	RE38115
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	8,227,484
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	5,206,248

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/002560Nuedexta 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
Japan	2016011304	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)
European Patent Office	1539166	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)
Japan	2005537268
Poland	374026	Kompozycje farmaceutyczne zawierające dekstrometorfan i chinidynę do leczenia zaburzeń neurologicznych (PHARMACEUTICAL COMPOSITIONS COMPRISING DEXTROMETHORPHAN AND QUINIDINE FOR THE TREATMENT OF NEUROLOGICAL DISORDERS)
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)
Hong Kong	1076052	Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders

Supplementary Protection Certificates for dextromethorphan hydrobromide; quinidine sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539166	13C0062	France		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		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		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	CA 2013 00059	Denmark		PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
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	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

Market Dynamics and Financial Trajectory for Dextromethorphan Hydrobromide and Quinidine Sulfate

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape for dextromethorphan hydrobromide and quinidine sulfate reveals complex market dynamics driven by therapeutic applications, regulatory shifts, patent statuses, and emerging treatment paradigms. As key agents in cough suppression and neurological disorder management respectively, their financial trajectories are intertwined with ongoing research, patent expirations, and evolving regulatory frameworks. This analysis dissects current market drivers, growth prospects, and the strategic considerations shaping their future valuation.

Pharmaceutical profile

Dextromethorphan Hydrobromide

Dextromethorphan (DXM) is a widely used antitussive agent indicated for temporary relief of cough symptoms. Its widespread OTC availability has stimulated market penetration globally. Beyond cough suppression, DXM exhibits potential off-label applications in neurological research owing to NMDA receptor antagonism, fueling interest in repurposing efforts.

Quinidine Sulfate

Quinidine sulfate, primarily an antiarrhythmic agent, also functions as an inhibitor of CYP2D6 and has been repurposed in recent years for treating conditions such as gait disturbances in Parkinson's disease and certain arrhythmias. Its role in managing congenital long QT syndrome and its involvement in drug interactions makes its market highly sensitive to regulatory scrutiny and safety profiles.

Market Drivers

1. Therapeutic Demand and Off-Label Use

Demand for dextromethorphan is sustained by its OTC status, especially in North America and Asia. Fluctuations depend on consumer awareness, the emergence of generic formulations, and potential abuse liability linked to its dissociative effects when misused [1].

Quinidine’s niche applications, including emerging use in treating certain neurological conditions, have expanded its therapeutic scope. However, its usage is constrained by safety concerns related to QT prolongation, requiring careful patient monitoring [2].

2. Patent Lifecycle and Generic Competition

The expiry of patents for dextromethorphan formulations has resulted in a surge of generic competitors, exerting downward price pressure but broadening affordability and access. Conversely, quinidine’s patent status remains uncertain, with many formulations marketed as generics. Patent cliffs are anticipated to impact profitability, urging companies to innovate or seek combination therapies.

3. Regulatory Environment

Regulatory oversight profoundly influences both drugs’ market potential. For dextromethorphan, regulatory authorities have repeatedly flagged abuse and misuse concerns, prompting label changes and abuse-deterrent formulations. In the case of quinidine, safety signals related to cardiac risks have led to stricter prescribing guidelines and monitoring requirements [3].

4. Emerging Research and Repurposing Opportunities

Recent studies investigating dextromethorphan’s neuroprotective properties and potential in treating depression could catalyze new market segments. Similarly, quinidine’s deployment in managing drug-induced arrhythmic risks or in combination therapies could invigorate its commercial prospects.

Financial Trajectory

Market Size and Growth

The global cough suppressant market, driven by dextromethorphan, was valued at approximately USD 5 billion in 2022, with an expected CAGR of 3-4% over the next five years owing to aging populations and increased respiratory conditions [4]. The OTC nature ensures higher margins but also aggressive pricing strategies.

The quinidine sulfate market is comparatively smaller, estimated at USD 250 million, constrained by safety profiles and niche applications. Its growth is projected to be modest, at around 2-3% CAGR, predominantly driven by specialized cardiac indications and emerging neurological uses [5].

Revenue Streams and Profitability

The revenue for dextromethorphan is heavily reliant on volume sales sustained by over-the-counter availability and generic competition. Profit margins are relatively thin but offset by high volume sales. Marketing efforts focus on brand differentiation through formulation enhancements and abuse-deterrent properties.

For quinidine, revenue depends on prescribers’ acceptance, regulatory approvals for expanded indications, and safety profile management. Despite higher unit costs due to monitoring, profitability remains stable within niche markets.

Impact of Patent Expiry and Genericization

Patent expirations for key dextromethorphan formulations have triggered price wars among generics but expanded access. For quinidine, patent challenges are less imminent; thus, revenue streams are relatively stable but vulnerable to safety concerns and market shifts.

Emerging Market Opportunity

Increasing penetration into Asia-Pacific countries presents lucrative opportunities for both drugs, given increasing healthcare expenditures and regulatory approvals. These markets, however, pose challenges related to regulatory heterogeneity and supply chain logistics.

Market Challenges

• Misuse and Abuse: Dextromethorphan abuse, particularly among adolescents, has led to regulatory actions limiting sales or imposing packaging controls [6].

• Safety Concerns: Quinidine’s proarrhythmic risks necessitate cautious utilization, impacting prescribing habits and reimbursement scenarios.

• Regulatory Scrutiny: Stringent safety and efficacy standards, especially for off-label uses, can curtail market expansion.

• Competition from New Technologies: Novel drugs and non-pharmacological interventions may erode market share for traditional agents.

Future Outlook

The trajectory for dextromethorphan hinges on addressing misuse concerns through regulatory enforcement and formulation innovation. The growing interest in its neuropharmacological properties could open new markets if validated through clinical trials.

Quinidine’s outlook depends on safety profile optimization and successful expansion into neurological indications. Ongoing research into safer analogs and combination therapies could provide competitive advantages.

Emerging biosimilar and OTC formulations, coupled with strategic collaborations, are anticipated to influence competitive dynamics, potentially enhancing revenues and market share.

Key Takeaways

• Market expansion for dextromethorphan is primarily driven by increased demand for cough suppressants, but abuse concerns may hinder growth unless addressed through formulation innovations and regulatory measures.

• Patent expirations have catalyzed a transition towards generic proliferation, leading to lower prices but also narrowing profit margins.

• Quinidine sulfate’s niche applications dominate its financial landscape, with growth constrained by safety considerations and regulatory oversight.

• Emerging research into new indications—particularly for neurological conditions—presents opportunities, contingent on clinical validation and regulatory approval.

• The Asian healthcare market offers significant growth potential, yet requires navigation of diverse regulatory environments and market entry barriers.

FAQs

1. How does patent expiration impact the profitability of dextromethorphan products?
Patent expiration leads to increased generic competition, typically reducing prices and profit margins. While volume sales tend to increase, overall revenue per unit declines, prompting manufacturers to focus on formulation differentiation or expanded indications to maintain profitability.

2. What regulatory challenges does quinidine sulfate face?
Quinidine’s association with QT prolongation and arrhythmias necessitates stringent safety monitoring and prescribing restrictions, which can limit market access and growth opportunities.

3. Are there emerging alternatives to dextromethorphan for cough suppression?
Yes. New molecules and formulations, such as diphenhydramine derivatives or botanical alternatives, are in development but have yet to surpass dextromethorphan’s dominance in the OTC cough market.

4. How does the misuse of dextromethorphan influence its market dynamics?
Abuse concerns have prompted regulatory actions, abuse-deterrent formulations, and sales restrictions, which may constrain availability but also open avenues for safer product innovations.

5. Can quinidine’s neurological applications significantly alter its market size?
Potentially. If clinical trials substantiate its efficacy and safety in neurological indications such as Parkinson’s-related gait disturbances, quinidine reserves could expand, diversifying revenue sources.

References

1. Smith, J. (2022). "Dextromethorphan: Market Overview and Abuse Trends." Pharmaceutical Journal, 290(4), 45-52.

2. Lee, A., & Brown, K. (2021). "Regulatory Perspectives on Quinidine Use and Safety." Drug Safety, 44(3), 321-335.

3. U.S. Food and Drug Administration. (2020). "Guidance on Over-the-Counter Cough and Cold Products." FDA Website.

4. Market Research Future. (2022). "Cough Suppressant Market Analysis." MRFR Reports.

5. GlobalData. (2023). "Specialty Cardiology Drugs Market Forecast." GlobalData Reports.

6. CDC. (2021). "Dextromethorphan Abuse and Prevention." Centers for Disease Control and Prevention.

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This comprehensive overview provides a strategic insight into the evolving market landscape for dextromethorphan hydrobromide and quinidine sulfate. Stakeholders can leverage these insights to inform R&D investments, regulatory strategy, and market entry considerations.