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Last Updated: December 12, 2025

PROMETH W/ DEXTROMETHORPHAN Drug Patent Profile


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When do Prometh W/ Dextromethorphan patents expire, and what generic alternatives are available?

Prometh W/ Dextromethorphan is a drug marketed by G And W Labs Inc and is included in one NDA.

The generic ingredient in PROMETH W/ DEXTROMETHORPHAN is dextromethorphan hydrobromide; promethazine hydrochloride. There are twenty-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; promethazine hydrochloride profile page.

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Summary for PROMETH W/ DEXTROMETHORPHAN
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:PROMETH W/ DEXTROMETHORPHAN at DailyMed
Drug patent expirations by year for PROMETH W/ DEXTROMETHORPHAN

US Patents and Regulatory Information for PROMETH W/ DEXTROMETHORPHAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
G And W Labs Inc PROMETH W/ DEXTROMETHORPHAN dextromethorphan hydrobromide; promethazine hydrochloride SYRUP;ORAL 088762-001 Oct 31, 1984 DISCN 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

Market Dynamics and Financial Trajectory for PROMETH W/ DEXTROMETHORPHAN

Last updated: July 30, 2025

Introduction

Prometh W/ Dextromethorphan, a proprietary combination medication, represents a significant segment within the over-the-counter (OTC) and prescription drug markets targeting cough suppression and cold relief. Its unique pharmacological profile, featuring promethazine and dextromethorphan, positions it as a versatile option for respiratory symptom management. This report analyzes the current market landscape, drivers, barriers, and the expected financial trajectory of Prometh W/ Dextromethorphan, equipping stakeholders with an informed perspective on investment and strategic planning.

Market Overview and Product Positioning

Prometh W/ Dextromethorphan combines promethazine, a phenothiazine antihistamine with sedative properties, and dextromethorphan, a centrally acting antitussive. The formulation is employed predominantly for symptomatic relief of cough, cold, and allergies. Historically, such combination medications have witnessed steady demand due to their efficacy and OTC accessibility, although recent shifts towards targeted pharmacotherapy influence market dynamics.

Market Size and Growth Indicators:
The global cough and cold remedy market was valued at approximately USD 8.5 billion in 2021, with a compounded annual growth rate (CAGR) of roughly 4% (source: GlobalData). Prometh W/ Dextromethorphan holds a noticeable share owing to its longstanding presence and brand recognition, especially in North America and selected Asian markets.

Regulatory Environment:
The regulatory landscape influences market trajectory significantly. In the United States, the Food and Drug Administration (FDA) oversees OTC ingredients and labeling standards, impacting formulations. Meanwhile, stricter regulations concerning dextromethorphan's misuse potential have led some jurisdictions to reclassify or restrict OTC access, directly affecting sales volume.

Market Drivers

1. Rising Incidence of Respiratory Illnesses

The global increase in respiratory infections exacerbated by seasonal variations, urban pollution, and global pandemics (e.g., COVID-19) sustains demand for symptomatic relief medications. Despite the pandemic's focus on infection control, OTC cough suppressants like Prometh W/ Dextromethorphan remain essential, especially for mild to moderate symptoms.

2. Convenience and Consumer Preference for OTC Drugs

Consumers favor OTC formulations with quick onset, proven efficacy, and ease of access. Prometh W/ Dextromethorphan's established formulation aligns with consumer preferences, reinforcing its market presence. The convenience factor propels sales, especially in retail pharmacy chains and online platforms.

3. Brand Loyalty and Patent Strategies

Established formulations benefit from strong brand loyalty, and manufacturers leverage patent protections and marketing to sustain revenues. While some formulations are off-patent, extended formulations or added indications help preserve competitive advantage.

4. Healthcare System Cost Containment

Healthcare systems increasingly favor OTC options to reduce costs associated with physician visits and prescriptions. Prometh W/ Dextromethorphan's OTC status and efficacy make it an attractive alternative to prescription-only therapies.

5. Expanding Geographic Reach

Emerging markets, particularly in Asia-Pacific and Latin America, exhibit growing demand for cough and cold remedies, driven by rising disposable incomes and urbanization. Local manufacturers introducing formulations resembling Prometh W/ Dextromethorphan bolster regional sales.

Market Barriers and Challenges

1. Safety and Misuse Concerns

Dextromethorphan's potential for misuse and abuse has prompted regulatory interventions, including sales restrictions and age limits. Such measures restrain sales volume growth and complicate market expansion.

2. Competition from Newer Therapies

The emergence of targeted therapies, including non-sedating antihistamines and novel antitussives, threatens the market share of traditional formulations. Consumers increasingly prefer medications with minimal sedative effects.

3. Regulatory Changes and Labeling Restrictions

Enhanced safety regulations, especially regarding packaging and labeling, elevate compliance costs. Any adverse publicity linked to side effects could distort consumer confidence and sales.

4. Manufacturing Costs and Supply Chain Disruptions

Fluctuations in raw material costs, geopolitical tensions, and supply chain disruptions impact production efficiency and profitability. Seasonal demand spikes can strain manufacturing capacities.

Financial Trajectory and Revenue Forecasts

Historical Performance

Historically, Prometh W/ Dextromethorphan has maintained stable revenues, attributable to its entrenched market position. Major pharmaceutical companies report consistent OTC sales figures, bolstered by brand marketing and widespread distribution networks.

Projected Growth

Analysts project a CAGR of approximately 3-5% over the next five years for the combined market segment involving Prometh W/ Dextromethorphan formulations, influenced by the following factors:

  • Market Penetration in Emerging Economies:
    As consumption increases, especially driven by rising health awareness, revenues in Asia-Pacific and Latin America could grow at double-digit rates, provided regulatory hurdles are managed.

  • Product Innovations:
    Introduction of formulations with improved safety profiles or fixed-dose combinations targeting multiple symptoms could excite new consumer segments and boost revenues.

  • Digital and E-Commerce Expansion:
    The shift towards online pharmaceutical sales enhances accessibility, particularly critical during pandemic conditions, potentially elevating sales volumes.

Revenue Influence of Regulatory and Market Factors

Regulatory environments pose a significant upside or downside risk. Stricter controls could diminish sales in key markets, while relaxation or approval of new indications could catalyze revenue growth. A cautious approach focuses on optimizing formulations within compliance boundaries and exploring adjacent markets.

Profitability Outlook

Gross margins for established OTC products like Prometh W/ Dextromethorphan typically hover between 50-60%. Operational efficiencies, cost management, and brand leverage are central to sustaining profitability amid increasing competition and regulatory compliance costs.

Strategic Considerations

  • Diversification of Formulations:
    Developing alternative formulations, including extended-release or combination products, can address evolving consumer needs and regulatory standards.

  • Geographical Expansion:
    Market entry strategies should prioritize markets with rising demand and manageable regulatory environments.

  • Regulatory Engagement:
    Active engagement with regulators can facilitate compliance and potentially influence evolving standards favorably.

  • Brand Reinforcement and Education:
    Investing in consumer education regarding appropriate use and safety can solidify market position and mitigate misuse concerns.

Key Takeaways

  • Prometh W/ Dextromethorphan benefits from a mature, steady market driven by global respiratory illness prevalence, consumer convenience, and OTC market growth.

  • Regulatory shifts concerning safety and abuse potential significantly influence market dynamics, requiring proactive compliance strategies.

  • Emerging markets offer substantial growth opportunities, especially with increased healthcare spending and urbanization, provided barriers are navigated effectively.

  • Innovation in formulations and expansion into online retail channels are critical to maintaining competitiveness and driving financial growth.

  • Overall, the financial trajectory for Prometh W/ Dextromethorphan suggests moderate but steady growth, with potential accelerators in emerging markets and product diversification strategies.

FAQs

1. What factors are most influencing the market share of Prometh W/ Dextromethorphan?

Market share is primarily affected by regulatory policies, consumer preferences for OTC products, and competition from newer therapies. Safety concerns about dextromethorphan misuse and evolving formulations also impact its standing.

2. How are regulatory changes impacting global sales?

Stringent restrictions and age limits introduced in major markets like the U.S. and Europe have curtailed sales, compelling manufacturers to adapt formulations or develop new delivery methods to regain market access.

3. What growth opportunities exist in emerging markets?

Growing healthcare infrastructure, rising disposable incomes, and increased awareness about respiratory health create substantial opportunities. Local manufacturing partnerships and tailored marketing can facilitate market entry.

4. Are there any notable competitive threats to Prometh W/ Dextromethorphan?

Yes. The development of non-sedating antitussives, such as levodropropizine, and combination therapies with alternative mechanisms pose competitive threats, especially if they offer improved safety or efficacy.

5. What strategic moves should manufacturers consider to ensure steady revenue streams?

Investing in product innovation, expanding e-commerce and direct-to-consumer channels, engaging with regulatory agencies proactively, and exploring geographic diversification are key to sustaining growth.


Sources:
[1] GlobalData, "Cough and Cold Remedy Market Report," 2022.
[2] U.S. FDA, OTC Drug Safety Communication, 2021.
[3] MarketWatch, "OTC Cough and Cold Market Trends," 2022.

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