IBUPROHM COLD AND SINUS Drug Patent Profile

When do Ibuprohm Cold And Sinus patents expire, 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ibuprohm Cold And Sinus

A generic version of IBUPROHM COLD AND SINUS was approved as ibuprofen; pseudoephedrine hydrochloride by STRIDES PHARMA on August 14^th, 2006.

Summary for IBUPROHM COLD AND SINUS

US Patents:	0
Applicants:	1
NDAs:	1

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

IBUPROHM COLD AND SINUS Market Analysis and Financial Projection

Last updated: February 15, 2026

What is the Market Position of IBUPROHM COLD AND SINUS?

IBUPROHM COLD AND SINUS is an over-the-counter (OTC) medication combining ibuprofen, pseudoephedrine, and chlorpheniramine. It targets combined relief of pain, fever, nasal congestion, and sinus pressure associated with cold and flu symptoms. Its positioning in the OTC cold relief segment provides a competitive edge due to its multi-symptom approach.

What Are the Core Ingredients and Their Market Significance?

• Ibuprofen: A non-steroidal anti-inflammatory drug (NSAID) with a long-established presence in OTC pain relievers. The global OTC ibuprofen market was valued at approximately USD 3.2 billion in 2021 and continues to grow at around 5% annually.
• Pseudoephedrine: Decongestant ingredient with regulatory constraints but high consumer demand for effective nasal relief. Its market faces strict regulation due to methamphetamine precursor restrictions, affecting supply chains and pricing.
• Chlorpheniramine: An antihistamine controlling allergy symptoms, aging demographic, and allergy prevalence locally support its ongoing use.

The combination targets multi-symptom relief, appealing in competitive OTC markets where consumers seek single-dose solutions.

What Are the Regulatory and Intellectual Property Considerations?

• Patent Landscape: Combining active ingredients typically falls under formulation patents, which may last 10–15 years from filing. Current patent protections on this specific combination may have expired or be close to expiration, opening the market to generics.
• Regulatory Approval: OTC status depends on local regulatory agencies like the FDA (U.S.), EMA (Europe), with approvals based on safety, efficacy, and labeling. Existing approvals facilitate market entry; however, newer formulations or delivery methods may require additional filings.

How Competitive Is the Market?

• Market Size: The OTC cold and flu segment globally exceeds USD 15 billion with steady growth driven by seasonal demand.
• Major Competitors: Brands like Tylenol Cold, Advil Cold & Sinus, and DayQuil offer similar multi-symptom formulations, often with patented combinations or local formulations.
• Pricing: Retail prices average USD 8–12 per package, with variations based on brand, dosing, and regional regulations.

What Are the Investment Risks?

• Regulatory Changes: Stricter controls on pseudoephedrine and other ingredients can limit formulation options or increase compliance costs.
• Market Saturation: Dominant brands block new entrants unless they offer differentiating features such as lower price, unique formulation, or innovative delivery methods.
• Patent Expirations: The near expiry of formulation patents increases risk of generic competition, pressuring margins.
• Supply Chain: Dependence on active ingredients with complex regulatory restrictions (pseudoephedrine) complicates supply stability and pricing.

How Does the Cost Structure Impact Profitability?

• Manufacturing: Approximate per-unit manufacturing costs range between USD 0.20–0.50, depending on scale and ingredient sourcing.
• Distribution: Distribution costs consume 10–15% of retail price.
• Marketing: OTC branding and regulatory compliance account for 10–20% of expenses.
• Pricing Power: Margins are typically 20–30% before marketing and regulatory costs; actual margins depend on competitive dynamics and patent status.

What Are the Key Growth Opportunities?

• Product Differentiation: Innovations such as sustained-release formulations or combining additional active ingredients can enhance competitiveness.
• Regional Expansion: Developing markets in Asia, Africa, and Latin America offer growth, driven by rising consumer awareness and healthcare infrastructure improvements.
• Regulatory Strategy: Engaging early with regulators facilitates faster approval, especially in emerging markets with less stringent controls.
• Branding and Loyalty: Investment in consumer awareness and brand trust can protect market share against generics.

What Are the Financial Forecasts?

• Revenue Projections: With an estimated market penetration of 2–5% in key regions within 3–5 years, revenues can range from USD 50–200 million annually.
• Investment Horizon: Break-even estimates depend on formulation costs, regulatory approval timelines, and marketing spend, typically 2–3 years for OTC products.
• Pricing Trends: Stable or slightly declining due to increasing generic competition, unless differentiated through branding or formulation.

Key Takeaways

• The OTC cold and sinus market remains sizable and competitive, with strong demand for multi-symptom relief.
• Patent expiration presents opportunities for generic proliferation, but also intensifies competitive pressures.
• Regulatory constraints, especially regarding pseudoephedrine, impact formulation design and supply chain stability.
• Growth hinges on regional expansion, product differentiation, and effective branding.
• Profitability depends on managing manufacturing costs, regulatory compliance, and competitive pricing.

FAQs

1. What is the primary competitive advantage of IBUPROHM COLD AND SINUS?
   Its multi-symptom formulation addresses pain, fever, congestion, and sinus pressure in a single OTC product.

2. How does patent expiry affect the product’s profit outlook?
   Patent expiration increases generic competition, reducing margins unless differentiating factors such as branding or formulation innovation are introduced.

3. What regulatory hurdles exist for OTC formulations containing pseudoephedrine?
   Stringent controls limit pseudoephedrine availability, affecting formulation options and supply chain stability.

4. Which regions offer the most promising growth opportunities?
   Emerging markets in Asia, Latin America, and parts of Africa due to rising demand and expanding healthcare infrastructure.

5. What are the key risks for investors in this product?
   Regulatory changes, patent expirations, fierce competition, rising raw material costs, and supply chain disruptions.

References

[1] Grand View Research. OTC Pain Management Market Size, Share & Trends Analysis. 2022.