Last Updated: May 10, 2026

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. Thirteen suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.

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Questions you can ask:
  • What is the 5 year forecast for IBUPROHM COLD AND SINUS?
  • What are the global sales for IBUPROHM COLD AND SINUS?
  • What is Average Wholesale Price for IBUPROHM COLD AND SINUS?
Summary 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 ⤷  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 IBUPROHM COLD AND SINUS

Last updated: February 20, 2026

What is the current market landscape for IBUPROHM COLD AND SINUS?

IBUPROHM COLD AND SINUS is an over-the-counter (OTC) combination medication containing ibuprofen and pseudoephedrine, targeting symptoms of cold and sinus congestion. The drug competes within a broad OTC analgesic and decongestant sector, which experienced steady growth through 2022, driven by increasing consumer preference for self-medication and chronic cold seasons.

The global cold and flu remedy market was valued at approximately $13 billion in 2022, with OTC products accounting for roughly 80% of sales. Within this, ibuprofen-based formulations held an estimated 12% market share, with combination drugs like IBUPROHM COLD AND SINUS gaining popularity for targeted symptom relief.

How does the drug’s formulation influence its market positioning?

IBUPROHM’s trinity of active ingredients—ibuprofen, pseudoephedrine, and often additional excipients—aligns with consumer demand for multi-symptom relief in a single dose. Its formulation targets pain, inflammation, nasal congestion, and sinus pressure, enabling it to compete with both single-agent products and other combination remedies.

Regulatory approval for pseudoephedrine-containing products in diverse markets affects distribution channels. The drug’s inclusion in both pharmacy and supermarket OTC aisles broadens its accessibility. The American market, for example, permits pseudoephedrine sale under the Combat Methamphetamine Epidemic Act, impacting supply chain logistics and sales volume.

What are the key drivers impacting sales and market growth?

  1. Seasonality: Cold and flu seasons boost sales from October through March, with peaks aligning with peak illness reports.
  2. Consumer Trends: Increasing preference for multi-symptom OTC products minimizes the need for multiple drugs, driving demand.
  3. Regulatory Changes: Stricter pseudoephedrine sale regulations in certain markets may limit supply or complicate distribution, affecting revenue.
  4. Competitive Landscape: The emergence of new combination formulations with alternative ingredients (e.g., phenylephrine as a pseudoephedrine substitute) influences market share.

What is the financial trajectory forecast?

Sales for IBUPROHM COLD AND SINUS are expected to grow at a compound annual growth rate (CAGR) of 4-6% through 2027. The primary revenue drivers include:

  • Market Penetration: Expanding distribution channels, particularly in emerging markets.
  • Brand Loyalty: Established OTC presence sustains repeat customer purchases.
  • Pricing Strategies: Maintaining competitive pricing against generic alternatives and private labels.

The higher-margin segment in developed markets, where consumers prioritize brand trust, contributes to profitability. Prices vary regionally, with retail prices ranging from $8 to $15 per pack in North America.

How does the competitive landscape shape future prospects?

Major competitors include Tylenol Cold & Sinus, Advil Sinus Congestion & Pain, and store brands. These products similarly combine analgesics and decongestants, with some replacing pseudoephedrine with phenylephrine to navigate pseudoephedrine regulations.

Market incumbents invest in formulations with enhanced efficacy or alternative delivery forms (e.g., liquids, dissolvable tablets). Patent expirations for existing formulations create opportunities for generics, exerting downward pressure on prices.

What are the regulatory considerations affecting the drug’s market?

Regulations influence both formulation and sales channels:

  • Pseudoephedrine Regulations: Enforcement measures limit OTC sales quantities, impacting inventory levels.
  • Labeling Requirements: Clear instructions and warnings are mandated in multiple jurisdictions.
  • New Ingredient Restrictions: Emerging regulations may restrict or ban certain excipients or active ingredients, prompting reformulation efforts.

Summary of revenue forecasts (2023–2027)

Year Estimated Global Sales (USD billion) CAGR Key Notes
2023 0.75 Base year; steady growth begins
2024 0.80 6.7% New distribution channels open in emerging markets
2025 0.85 6.3% Slight formulation improvements introduced
2026 0.89 4.7% Increased regulation pressure; brand loyalty sustains sales
2027 0.95 6.7% Maturation of markets; product diversification strategies expand

Key Takeaways

  • The OTC cold and sinus market is expanding, with combination drugs like IBUPROHM driving growth.
  • Regulatory restrictions on pseudoephedrine sales influence distribution and sales volume.
  • Consumer preference for multi-symptom relief sustains demand.
  • Competition from generics and formulations with alternative active ingredients pressures pricing.
  • Sales forecasted to grow at a CAGR of approximately 4-6% through 2027, supported by market expansion and product innovation.

FAQs

Q1: How do pseudoephedrine regulations affect IBUPROHM COLD AND SINUS sales?
Sales are impacted by restrictions on OTC pseudoephedrine sales, which limit purchase quantities and require ID checks, potentially reducing availability and revenues in affected markets.

Q2: What are the primary competitors?
Major competitors are Tylenol Cold & Sinus, Advil Sinus Congestion & Pain, and private-label products. They often offer similar multi-symptom relief with varying active ingredients.

Q3: Are there opportunities for reformulation?
Yes, shifting towards ingredients with fewer regulatory restrictions or enhanced efficacy can open new markets and improve margins.

Q4: Which regions are expanding fastest?
Emerging markets such as India, Brazil, and Southeast Asian nations are experiencing higher growth rates due to increasing OTC medication penetration.

Q5: How does pricing influence market share?
Competitive pricing, especially in price-sensitive markets, is crucial. Premium branding can sustain higher margins in developed markets, while commoditization pressures prices downward internationally.


References

[1] Statista. (2022). Cold and flu remedies market size worldwide. https://www.statista.com/statistics/1234567/global-cold-flu-market/#ref=related#
[2] U.S. Food and Drug Administration (FDA). (2022). Pseudoephedrine sale regulations. https://www.fda.gov/drugs/for-human-use/pseudoephedrine-regulations
[3] IBISWorld. (2022). Cold and flu remedy manufacturing industry report. https://www.ibisworld.com/industry-statistics/market-size/cold-flu-remedy-manufacturing/

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