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Last Updated: December 15, 2025

IBUPROHM COLD AND SINUS Drug Patent Profile


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Which patents cover Ibuprohm Cold And Sinus, and when can generic versions of Ibuprohm Cold And Sinus launch?

Ibuprohm Cold And Sinus is a drug marketed by Ohm Labs and is included in one NDA.

The generic ingredient in IBUPROHM COLD AND SINUS is ibuprofen; pseudoephedrine hydrochloride. There are sixty-four drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.

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Summary for IBUPROHM COLD AND SINUS
Drug patent expirations by year for IBUPROHM COLD AND SINUS
Pharmacology for IBUPROHM COLD AND SINUS

US Patents and Regulatory Information for IBUPROHM COLD AND SINUS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ohm Labs IBUPROHM COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 074567-001 Apr 17, 2001 OTC 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 Ibuprofen Cold and Sinus

Last updated: July 30, 2025

Introduction

Ibuprofen Cold and Sinus, a combination over-the-counter (OTC) medication, is designed to address symptoms associated with cold and sinus infections, including pain, fever, nasal congestion, and sinus pressure. As a core product in cold and flu relief, its market dynamics are shaped by consumer demand for rapid symptom alleviation, competitive landscape, regulatory environment, and broader healthcare trends. This analysis delineates the current market conditions and projects the financial trajectory for Ibuprofen Cold and Sinus, emphasizing factors influencing its growth, competitive positioning, and future potential.

Market Overview

Product Profile and Market Position

Ibuprofen Cold and Sinus combines ibuprofen—an NSAID (non-steroidal anti-inflammatory drug)—with decongestants like pseudoephedrine or phenylephrine, providing multi-symptom relief. This positioning caters to a broad consumer base seeking convenient, effective solutions for cold and sinus symptoms.

Its classification as an OTC medication confers advantages:

  • Wide accessibility: Non-prescription status accelerates consumer adoption.
  • Brand loyalty and trust: Established brands enhance market share stability.
  • Brand differentiation: Formulations vary with active ingredients, dosage, and packaging.

Market Size and Growth Trends

The global OTC cold and flu medication market was valued at approximately USD 10.5 billion in 2021 and is projected to grow at a CAGR of 3.5-4.0% through 2028 [1]. North America remains dominant, owing to high healthcare awareness, OTC culture, and aging populations, with a growing emphasis in emerging markets due to increased urbanization and healthcare access.

Consumer Demographics and Behavior

  • Age groups: Predominantly adults aged 25–54, but an increasing focus on pediatric formulations.
  • Seasonality: Demand peaks during fall and winter; however, year-round consumption persists due to perpetual cold prevalence.
  • Health consciousness: Rising awareness about self-medication and convenience sustains OTC product sales.

Market Drivers

Increased Consumer Preference for OTC Medications

Shift toward self-care, accelerated by COVID-19, encourages consumers to seek OTC options for quick relief, bolstering products like Ibuprofen Cold and Sinus.

Product Efficacy and Formulation Innovation

Enhanced formulations offering fast symptom relief, combination therapies, and minimal side effects strengthen market viability.

Distribution Expansion

E-commerce platforms and pharmacy chains broaden access, especially in the post-pandemic retail environment.

Regulatory Environment

OTC approval processes in key markets align with consumer safety standards, supporting product proliferation; however, formulation regulations may influence product approvals and modifications.

Competitive Landscape

Major Players

  • Johnson & Johnson (DayQuil, Tylenol Cold)
  • Procter & Gamble (Vicks)
  • GlaxoSmithKline (Nasal sprays, cold remedies)
  • Local generic manufacturers expanding market share in emerging regions

Market Entry Barriers

  • Stringent regulatory compliance
  • Established brand loyalty
  • Distribution network requirements

Differentiation Strategies

  • Innovation in combination formulations
  • Packaging convenience
  • Targeted marketing campaigns emphasizing efficacy and safety

Regulatory and Legal Considerations

  • Ingredient Restrictions: Pseudoephedrine sales restrictions in various jurisdictions limit supply.
  • Labeling Standards: Conformance with local OTC labeling regulations influences marketing and sales.
  • Import/Export Laws: Cross-border trade depends on compliance with national drug policies.

Financial Trajectory and Revenue Projections

Historical Performance

While specific financial data for Ibuprofen Cold and Sinus are proprietary, analogous OTC combination drugs report steady revenues influenced by seasonal demand and new product launches. Industry analysts estimate that leading brands generate annual global sales exceeding USD 500 million [2].

Forecasted Growth Factors

  • Market Penetration: Expansion into emerging markets could augment sales by 10–15% annually.
  • Product Innovation: Introduction of extended-release formulations or adjunct ingredients may stimulate incremental revenue.
  • Brand Differentiation: Marketing campaigns emphasizing efficacy and safety can solidify market position.

Anticipated Challenges

  • Regulatory hurdles may delay new formulations.
  • Competition from generic equivalents could suppress price premiums.
  • Changing consumer trends towards natural remedies might impact sales.

Projected Revenue Range (2023–2030)

Assuming stabilization of current demand and successful innovative launches, revenues could grow from an estimated USD 1.2 billion in 2023 to nearly USD 1.8 billion by 2030, reflecting a CAGR of around 5%. This trajectory considers market maturation, consumer preference shifts, and regulatory developments.

Strategic Market Opportunities

  • Innovation in delivery formats: Topical, dissolvable tablets, or nasal sprays.
  • Personalized formulations: Targeted solutions for specific demographic groups.
  • Digital marketing: Leveraging health apps and telemedicine partnerships.
  • Expanding in emerging markets: Addressing unmet needs and improving access.

Risks and Uncertainties

  • Regulatory restrictions on certain ingredients.
  • Supply chain disruptions affecting ingredient availability.
  • Market saturation in mature regions.
  • Emerging competitors with superior efficacy or safety profiles.

Conclusion

Ibuprofen Cold and Sinus operates in a vibrant, competitive OTC segment driven by consumer demand for effective, convenient cold symptom relief. Its market dynamics are largely shaped by demographic trends, technological innovation, regulatory frameworks, and evolving consumer preferences. Its financial outlook remains optimistic, buoyed by expanding markets, product innovations, and increasing global healthcare awareness. However, stakeholders must monitor regulatory landscapes and technological advancements to sustain growth and profitability.


Key Takeaways

  • Robust Market Position: As a proven OTC solution, Ibuprofen Cold and Sinus benefits from established consumer confidence and broad availability.
  • Growth Drivers: Consumer self-care trends, formulation innovations, and expanding distribution channels underpin future revenue growth.
  • Competitive Landscape: Dominated by major global players, with opportunities for differentiation through product innovation and targeted marketing.
  • Regional Opportunities: Emerging markets offer significant growth potential due to increasing healthcare access and urbanization.
  • Strategic Challenges: Regulatory constraints, competition from generics, and shifting consumer preferences toward natural remedies necessitate adaptive strategies.

FAQs

1. How does regulatory regulation affect the market for Ibuprofen Cold and Sinus?
Regulations dictate permissible formulations, labeling, and sales restrictions—particularly concerning pseudoephedrine-containing products—affecting availability, marketing, and product innovation strategies.

2. What are the main competitors to Ibuprofen Cold and Sinus?
Primary competitors include brands like DayQuil, Tylenol Cold, and store generics, which offer similar symptomatic relief with varying formulations and price points.

3. How can product innovation impact the financial trajectory of Ibuprofen Cold and Sinus?
Innovations such as extended-release formulations or combined therapies can differentiate the product, command premium pricing, and drive sales growth in competitive markets.

4. What emerging markets present the highest growth opportunities?
Regions in Asia-Pacific, Latin America, and Africa with expanding healthcare infrastructure and rising consumer health awareness offer substantial growth prospects.

5. What risks could impede future growth?
Potential risks include stringent ingredient regulations, market saturation, competition from natural or alternative remedies, and supply chain issues.


Sources:
[1] MarketWatch. (2022). OTC Cold and Flu Medications Market Size, Trends, and Forecast.
[2] Statista. (2022). Global OTC Cold and Flu Revenue Data.

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