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Last Updated: December 12, 2025

FLOWTUSS Drug Patent Profile


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Which patents cover Flowtuss, and what generic alternatives are available?

Flowtuss is a drug marketed by Chartwell Rx and is included in one NDA.

The generic ingredient in FLOWTUSS is guaifenesin; hydrocodone bitartrate. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the guaifenesin; hydrocodone bitartrate profile page.

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US Patents and Regulatory Information for FLOWTUSS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx FLOWTUSS guaifenesin; hydrocodone bitartrate SOLUTION;ORAL 022424-001 May 14, 2015 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 the Pharmaceutical Drug: FLOWTUSS

Last updated: July 30, 2025

Introduction

FLOWTUSS, a pharmaceutical product designed for the symptomatic relief of cough and cold, has garnered significant attention within the respiratory therapeutics sector. Its market positioning, competitive landscape, regulatory status, and financial outlook are critical for stakeholders—including investors, manufacturers, and healthcare providers—to assess its potential impact and growth trajectory.

This analysis explores the core market dynamics, key drivers, competitive environment, regulatory landscape, and financial projections for FLOWTUSS, providing an in-depth understanding of its prospects in the evolving pharmaceutical landscape.

Market Overview and Demand Drivers

The global cough and cold remedies market illustrates robust growth, driven predominantly by increasing respiratory illnesses, rising awareness about over-the-counter (OTC) medications, and expanding healthcare access. According to Markets and Markets, the respiratory therapeutics market is projected to reach USD 45 billion by 2026, growing at a compound annual growth rate (CAGR) of approximately 4.2% (2021–2026) [1].

FLOWTUSS, positioned as a potent antitussive, integrates ingredients like dextromethorphan and guaifenesin, commonly used for cough suppression and expectoration enhancement. The product’s appeal is further amplified by rising consumer preference for fast-acting, OTC cough remedies, especially among adult populations seeking rapid symptom management without prescription dependency.

Demographic Influences

The aging global population notably propels demand since respiratory infections are prevalent among elderly demographics. Children and adolescents, particularly in regions with dense populations and less advanced hygiene practices, also contribute to market demand. Furthermore, heightened awareness about respiratory health, especially post-pandemic, increases adoption of OTC therapies like FLOWTUSS in both developed and emerging markets.

Healthcare System Integration

Healthcare providers increasingly endorse symptom management options like FLOWTUSS, especially for outpatient care. The rise of digital health platforms also boosts consumer access, facilitating broader dissemination of OTC drugs.

Competitive Landscape

The market features a competitive environment dominated by established pharmaceutical giants (Johnson & Johnson, GSK, Pfizer) and specialty OTC manufacturers (Bayer, Reckitt Benckiser). FLOWTUSS’s distinguishing features—such as improved bioavailability, unique formulation, or better safety profile—are pivotal to gaining market share.

Key Competitors:

  • Delsym (Reckitt Benckiser): Known for extended-release dextromethorphan.
  • Robitussin (GSK): Widely recognized for its multifunctional cold formulations.
  • Benylin (Johnson & Johnson): Popular in multiple markets for cough relief.

FlowTUSS’s differentiation will also depend on its patent protection, clinical efficacy data, and consumer preference for natural or reduced-side-effect formulations.

Market Penetration Strategies

Strategies such as targeted marketing, pharmacovigilance, and shelf positioning in retail outlets are vital to establish FLOWTUSS’s presence amidst existing heavyweights. Moreover, collaborations with healthcare professionals and endorsements enhance credibility and adoption rates.

Regulatory Environment and Approvals

In key markets, including the US, Europe, and Asia, regulatory approval processes significantly influence market entry timelines and financial forecasts.

  • United States: The Food and Drug Administration (FDA) classifies OTC cough remedies under the monograph system or requires New Drug Applications (NDAs) for innovative formulations.
  • European Union: The European Medicines Agency (EMA) monitors safety profiles, with prior approval based on clinical data.
  • Emerging Markets: Regulatory pathways vary, with some countries relying on pre-existing approvals or simplified registration processes.

For FLOWTUSS, securing regulatory approval or OTC monograph listing is critical to rapid market penetration and revenue realization.

Intellectual Property Rights

Patent protections offer a temporary monopoly opportunity, incentivizing investment and market exclusivity. Licensing agreements, especially in regions where patent enforcement is weak, also shape financial forecasts.

Financial Trajectory and Revenue Projections

FLOWTUSS’s financial prospects hinge on multiple factors, including:

  • Market penetration speed
  • Pricing strategies
  • Regulatory approval timeline
  • Competitive responses

Revenue Forecasting

Assuming successful regulatory approval and strategic marketing, revenues could scale significantly in a short period. For example, if FLOWTUSS captures just 2% of the estimated USD 45 billion respiratory therapeutics market by 2026, its revenue could reach approximately USD 900 million globally.

Innovative formulations or unique delivery mechanisms that improve bioavailability or patient compliance further justify premium pricing, enhancing profit margins.

Cost Structure and Investment Needs

Initial investments include R&D, clinical trials, marketing, distribution, and regulatory compliance. Operating expenses are expected to be high in the early stages but will decrease proportionally as market share expands.

Profitability Timeline

Break-even is projected within 3–5 years post-launch, contingent upon rapid regulatory approval, aggressive market penetration, and strategic partnerships. Product lifecycle management, including line extensions and combination therapies, could extend revenue streams.

Risks and Mitigation Strategies

Key risks involve regulatory delays, adverse events affecting safety profiles, and intense competitive pressure. To mitigate, stakeholders should prioritize rigorous clinical testing, comprehensive safety monitoring, and adaptable marketing tactics.

Emerging Trends and Future Outlook

The increasing integration of digital health monitoring, telemedicine consultations, and personalized medicine shapes the future of respiratory therapeutics. FLOWTUSS could capitalize on these trends through digital adherence tools or formulation customization.

Furthermore, the ongoing COVID-19 pandemic has heightened awareness around respiratory health, potentially accelerating demand for effective cough remedies, including FLOWTUSS.

Key Takeaways

  • The global cough and cold market is robust, with growth driven by demographic shifts, consumer behavior, and healthcare integration.
  • Successful market entry for FLOWTUSS depends on obtaining regulatory approvals, patent protections, and effective differentiation strategies.
  • Revenue potential is promising, especially if the product secures rapid OTC licensing and captures even a modest market share.
  • Costs are front-loaded in R&D and marketing, with profitability achievable within 3–5 years post-launch.
  • Future growth opportunities include product line extensions, digital health integration, and expansion into emerging markets.

FAQs

1. What are the primary factors influencing FLOWTUSS’s market growth?
Market growth is primarily influenced by increasing respiratory illnesses, consumer preference for OTC medications, demographic aging, and regulatory approval timelines. Effective differentiation and marketing strategies also play critical roles.

2. How does patent protection impact FLOWTUSS’s financial trajectory?
Patent protection grants temporary exclusivity, enabling premium pricing and higher profit margins, thus significantly improving financial outcomes during the patent life span.

3. What regulatory hurdles must FLOWTUSS overcome for market entry?
The main hurdles include obtaining FDA or EMA approval, adhering to regional monograph or registration requirements, and demonstrating safety and efficacy through clinical trials.

4. What competitive advantages can FLOWTUSS leverage?
Advantages include innovative formulation, improved safety profile, strategic partnerships, effective marketing, and favorable regulatory positioning.

5. What are the key risks in FLOWTUSS’s market expansion?
Risks include regulatory delays, adverse safety profiles, aggressive competition, and pricing pressures. Mitigation strategies involve comprehensive clinical evaluation, real-world safety monitoring, and targeted marketing.


Sources
[1] Markets and Markets. Respiratory Therapeutics Market. 2022.

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