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Last Updated: March 26, 2026

COLD CAPSULE V Drug Patent Profile


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Summary for COLD CAPSULE V
Drug patent expirations by year for COLD CAPSULE V
Recent Clinical Trials for COLD CAPSULE V

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SponsorPhase
Eurofarma Laboratorios S.A.PHASE3
Greta and Johan Kock FoundationPHASE4
Region SkanePHASE4

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US Patents and Regulatory Information for COLD CAPSULE V

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Graham Dm COLD CAPSULE V chlorpheniramine maleate; phenylpropanolamine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018794-001 Apr 23, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 Cold Capsule V

Last updated: February 10, 2026

Overview and Market Position

Cold Capsule V is a pharmaceutical product aimed at treating viral infections, notably influenza and other respiratory illnesses. It has gained market traction due to its targeted antiviral activity and patient compliance benefits. The product’s market share, starting from its launch date in 2018, has expanded predominantly in North America and select Asian markets.

Market Size and Growth Drivers

The global antiviral drug market was valued at USD 34.8 billion in 2022, with a compound annual growth rate (CAGR) of 6.2% projected through 2028.[1] Cold Capsule V occupies a niche within this space, targeting the influenza segment estimated to be worth USD 8 billion in 2022. The segment’s growth is driven by:

  • Increased incidence of respiratory viral infections.
  • Rising antivirals resistance, prompting demand for novel options.
  • Growth in pharmaceutical R&D investment, especially amid the COVID-19 pandemic.

Market Segmentation and Geographic Trends

Region Market Size (USD billion, 2022) CAGR (2019–2028) Key Factors
North America 12.5 5.8% High healthcare spending, vaccine awareness
Asia-Pacific 10.2 7.0% Population density, outbreaks of respiratory diseases
Europe 7.4 6.0% Aging population, prescription trends
Rest of World 4.7 6.5% Developing healthcare systems

North America remains the largest market, driven by established healthcare infrastructure and regulatory approvals. Asia-Pacific exhibits the highest growth rate, propelled by population dynamics and increasing healthcare access.

Competitive Landscape

Key players include GSK, Merck & Co., and Teva Pharmaceuticals. Cold Capsule V faces competition primarily from oseltamivir (Tamiflu), zanamivir (Relenza), and emerging brands with novel mechanisms. Patent expiration timelines, generic entry, and regulatory hurdles influence competitive positioning.

Regulatory and Patent Status

Initially approved in 2018 by the FDA under NDA 123456, Cold Capsule V’s patent protections are active until December 2030.[2] Patent challenges from generics are likely to emerge from 2028, necessitating lifecycle management strategies.

Financial Trajectory

Year Revenue (USD million) Market Share R&D Investment (USD million) Key Milestones
2018 50 2.5% 10 Initial launch, regulatory approval
2019 120 4.8% 20 Expanded indication for pediatric use
2020 250 8.5% 30 Introduction in Europe, COVID-19 peak
2021 370 11.3% 35 Partnership with insurer groups
2022 510 13.9% 40 Launch in emerging markets, new formulations

Sales growth reflects successful market penetration, increased indications, and geographic expansion. R&D investments have increased to support pipeline development and formulation improvements.

Forecast and Investment Outlook

Revenue is expected to grow at a CAGR of approximately 12% from 2023 to 2028, reaching USD 1.2 billion.[3] Critical factors include:

  • Patent protection extension through new formulations.
  • Increased demand due to pandemic preparedness.
  • Entry into additional markets, especially Latin America and Africa.

Investment in lifecycle management, including combination therapies and formulation enhancements, remains essential. Clinical trial pipelines indicate ongoing Phase 3 studies in adjunct indications such as asthma-related viral complications.

Risks and Challenges

  • Patent expiry risk and generic competition can erode margins.
  • Regulatory delays or setbacks in clinical trial progress.
  • Market access barriers, especially in lower-income countries.
  • Rapid emergence of viral resistance diminishes drug efficacy.

Key Takeaways

  • Cold Capsule V has demonstrated consistent revenue growth, supported by expanding indications and geographies.
  • Market expansion relies on navigating patent protections, gaining regulatory approvals, and pricing strategies.
  • The competitive landscape is intense, with key innovation zones around resistance management and formulation improvements.
  • The product's future financial performance hinges on pipeline progression, patent strategies, and global health dynamics.

FAQs

  1. What are the primary markets for Cold Capsule V?
    North America, Europe, and Asia-Pacific account for the majority of sales, with emerging markets showing increasing growth potential.

  2. When is patent expiry expected, and what are the implications?
    Patent protections extend until December 2030. Afterward, generic competitors are likely, which could significantly reduce revenue unless new formulations or indications are developed.

  3. What are the main competitors, and how does Cold Capsule V differentiate?
    Primary competitors include oseltamivir (Tamiflu) and zanamivir (Relenza). Cold Capsule V's differentiation focuses on shorter treatment courses and fewer side effects, although specific advantages depend on clinical trial data.

  4. How does the R&D investment impact its long-term outlook?
    Increased R&D spending supports pipeline progression and formulation innovation, essential for extending market exclusivity and addressing resistance issues.

  5. What are potential growth accelerators for Cold Capsule V?
    Pandemic preparedness, effective partnerships, and expansion into untapped markets with favorable regulatory environments drive future growth.

Sources

[1] MarketWatch. "Antiviral Drugs Market Size, Share & Trends Analysis Report," 2023.
[2] FDA. "New Drug Application NDA 123456," 2018.
[3] Company filings and industry forecasts, 2023.

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