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Last Updated: December 11, 2025

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE Drug Patent Profile


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Which patents cover Dextromethorphan Hydrobromide And Quinidine Sulfate, and when can generic versions of Dextromethorphan Hydrobromide And Quinidine Sulfate launch?

Dextromethorphan Hydrobromide And Quinidine Sulfate is a drug marketed by Actavis Elizabeth and Hetero Labs Ltd Iii and is included in two NDAs.

The generic ingredient in DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE is dextromethorphan hydrobromide; quinidine sulfate. There are twenty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; quinidine sulfate profile page.

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Summary for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
Drug patent expirations by year for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
Recent Clinical Trials for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

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SponsorPhase
Avanir PharmaceuticalsPhase 4
Avanir PharmaceuticalsPhase 2
Avanir PharmaceuticalsPhase 1

See all DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE clinical trials

US Patents and Regulatory Information for DEXTROMETHORPHAN HYDROBROMIDE AND 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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hetero Labs Ltd Iii DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE dextromethorphan hydrobromide; quinidine sulfate CAPSULE;ORAL 218426-001 Aug 28, 2024 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for DEXTROMETHORPHAN HYDROBROMIDE AND 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Market Dynamics and Financial Trajectory for Dextromethorphan Hydrobromide and Quinidine Sulfate

Last updated: August 2, 2025


Introduction

Dextromethorphan Hydrobromide (DMX) and Quinidine Sulfate (QND) are pharmaceutical compounds with distinct therapeutic roles, often combined for specific clinical applications. Their market dynamics and financial trajectories are influenced by factors such as therapeutic indications, regulatory landscape, competitive environment, and emerging scientific research. As a potent combination, their commercial outlook warrants detailed analysis to inform stakeholders, including pharmaceutical companies, investors, and healthcare providers.


Therapeutic Applications and Market Potential

Dextromethorphan Hydrobromide is predominantly used as an antitussive agent, effective in suppressing cough reflex in cold and cough remedies. Its over-the-counter (OTC) availability in many markets enables widespread usage, supported by its safety profile when used appropriately. Emerging research explores off-label uses, such as neuroprotective effects in neurological disorders and potential benefits in depression and neurodegenerative diseases.

Quinidine Sulfate historically served as an antiarrhythmic agent, particularly for atrial fibrillation and flutter. More recently, its chemical properties have catalyzed interest in its role as an enantiomeric suppressor of certain drug-induced adverse effects, including in some experimental therapies involving dupilumab or certain cardiac arrhythmias.

The combination of DMX and QND surfaces in niche therapeutic areas like pseudobulbar affect and specific arrhythmia management, although market penetration remains limited. However, the evolving pharmaceutical landscape and precision medicine could expand applications, especially if new formulations prove superior or hold advantages over existing therapies.


Market Drivers

1. Regulatory Environment

Regulatory agencies such as the FDA and EMA play critical roles in shaping market access. While Dextromethorphan’s OTC status accelerates its consumer penetration, quinidine’s prescription-restricted use limits widespread commercialization. Recently, there have been efforts to reformulate or develop new delivery systems, which could ease regulatory pathways.

2. Scientific Research and Clinical Trials

Advances in neuropharmacology and cardiac electrophysiology influence the development of new indications. Notably, research into dextromethorphan’s neuroprotective effects and its role in psychiatry, such as in ketamine-like depression treatment, could catalyze demand. Similarly, quinidine’s emerging applications in expanding its utility beyond traditional arrhythmias support future growth.

3. Patient Demographics

Aging populations in North America, Europe, and parts of Asia drive demand for cardiovascular medications like quinidine. Concurrently, increasing awareness of cough suppressants benefits sustains OTC demand for dextromethorphan-containing products.

4. Competitive Landscape

The availability of alternative antitussives (e.g., codeine, benzonatate) and antiarrhythmic agents (e.g., amiodarone, sotalol) compete with DMX/QND formulations. Market share depends on efficacy, safety profiles, cost, and regulatory approvals.


Market Challenges

1. Safety and Abuse Concerns:
Dextromethorphan’s potential for misuse and abuse, especially at high doses, has resulted in regulatory scrutiny and restrictions, particularly in the U.S. Such concerns may limit formulation innovation or restrict OTC availability.

2. Narrow Therapeutic Index:
Quinidine’s risk of significant adverse effects (e.g., QT prolongation, torsades de pointes) constrains its market growth. Developing safer derivatives or alternative delivery systems remains a priority.

3. Competition from Novel Agents:
Emerging drugs with improved efficacy and safety profiles threaten traditional therapies involving these compounds.

4. Patent and Exclusivity Expiry:
Generic competition post-patent expiry erodes margins, emphasizing the need for innovation, such as combination formulations or novel delivery routes.


Financial Trajectory and Investment Outlook

Current Market Size and Revenue

The global OTC cough remedy market, where dextromethorphan is prominent, exceeds USD 17 billion annually (Source: GlobalData, 2022). Its segment is mature, with steady growth driven by emerging markets and increasing health awareness.

The antiarrhythmic market, encompassing quinidine, is projected to grow modestly, reaching approximately USD 2–3 billion in the next five years, driven by patent expiries and the development of targeted therapies.

The specific niche involving combined DMX/QND applications is relatively small but offers high-margin opportunities if empirical evidence supports expanded use.

Growth Projections

  • Dextromethorphan Market: Expected to grow at a CAGR of 3-5%, bolstered by novel formulations and off-label use research. The growth may slow in mature markets due to saturation but remain promising in emerging economies.

  • Quinidine Market: Growth is constrained to niche indications, with projections around 1-2% CAGR due to safety concerns and competition. Innovation, such as slow-release formulations, could alter this trajectory favorably.

Key Considerations for Investment

  • Innovation and Reformulation: Investment in combination formulations with improved safety, advanced delivery systems, or targeted indications could unlock new revenue streams.

  • Regulatory Approvals: Securing approvals for new indications or formulations could significantly enhance financial prospects.

  • Market Penetration in Emerging Economies: Expanding access in regions with growing healthcare infrastructure offers compelling growth avenues.

  • Monitoring Regulatory Changes: Policies addressing abuse potential or safety concerns may impact market access and profitability.


Emerging Trends and Future Outlook

  • Personalized Medicine: Genetic profiling may influence quinidine’s use, optimizing dosing and reducing adverse effects.

  • Digital Health Integration: Utilizing telemedicine and remote monitoring could facilitate safer quinidine therapy management.

  • Scientific Advances: Ongoing research into dextromethorphan’s neuroprotective properties could lead to FDA-approved indications beyond cough suppression, expanding the market substantially.

  • Alternative Therapies: The rise of cannabis-derived products or novel neuroactive agents might compete or complement existing therapies involving DMX and QND.


Key Takeaways

  • The market for dextromethorphan remains substantial, driven by its OTC availability and potential in emerging neurological therapeutics. The quinidine market is more limited but holds niche stability owing to its specific antiarrhythmic role.

  • Industry growth opportunities hinge on innovative formulations, expanding indications, and regulatory approvals, especially in emerging markets.

  • Safety concerns and regulatory restrictions are key challenges, particularly pertinent to quinidine’s cardiac risks and dextromethorphan’s abuse potential.

  • Strategic investments should focus on R&D for safer, targeted formulations and pursuing clinical trials that substantiate new therapeutic claims.

  • The future landscape features a blend of technological advancements, personalized medicine, and ongoing scientific research, which could redefine the commercial viability of these compounds.


FAQs

1. What factors influence the market share of dextromethorphan-based products?
Market share is influenced by regulatory status, consumer awareness, availability of alternative therapies, safety profile concerns, and ongoing research into new indications.

2. How do safety concerns impact quinidine's commercial prospects?
Risks such as QT prolongation limit quinidine’s use, necessitating careful patient selection and monitoring, which can hinder broader market penetration and reduce profitability.

3. Are there ongoing developments that could expand the therapeutic use of DMX and QND?
Yes. Advances in neuropharmacology suggest potential new uses for dextromethorphan, while research into safer antiarrhythmic derivatives could extend quinidine’s applicability.

4. How does regulatory scrutiny about misuse affect dextromethorphan products?
Restrictions on high-dose OTC formulations and monitoring in certain regions aim to combat abuse, which can constrain product innovation and market growth.

5. What investment strategies are recommended for companies interested in these compounds?
Focusing on novel formulations, securing regulatory approvals for new indications, and expanding into emerging markets represent viable pathways for growth in this sector.


References

[1] GlobalData, "Over-the-Counter Cough Remedies Market, 2022."
[2] MarketWatch, "Antiarrhythmic Drugs Market Analysis," 2022.
[3] FDA & EMA regulatory updates, 2022.
[4] Scientific literature on dextromethorphan’s neuroprotective roles.
[5] Industry reports on pharmaceutical innovation and safety regulations.


This comprehensive analysis provides a detailed understanding of the current market landscape and future possibilities for dextromethorphan hydrobromide and quinidine sulfate, equipping stakeholders to make informed decisions.

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