OMECLAMOX-PAK Drug Patent Profile

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When do Omeclamox-pak patents expire, and what generic alternatives are available?

Omeclamox-pak is a drug marketed by Cumberland and is included in one NDA.

The generic ingredient in OMECLAMOX-PAK is amoxicillin; clarithromycin; omeprazole. Additional details are available on the amoxicillin; clarithromycin; omeprazole profile page.

Summary for OMECLAMOX-PAK

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for OMECLAMOX-PAK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cumberland	OMECLAMOX-PAK	amoxicillin; clarithromycin; omeprazole	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL	050824-001	Feb 8, 2011		DISCN	Yes	No

Investment Scenario and Fundamentals Analysis for OMECLAMOX-PAK

Last updated: February 23, 2026

What is OMECLAMOX-PAK?

OMECLAMOX-PAK is a combination drug containing amoxicillin and clavulanic acid, used primarily for bacterial infections such as respiratory tract, urinary tract, and skin infections. The product is widely marketed as a broad-spectrum antibiotic.

Market Overview

Global Antibiotics Market:

• Estimated to reach USD 45 billion by 2027, growing at a CAGR of 3.8% from 2020 to 2027 (Source: Grand View Research).
• Increasing antibiotic resistance prompts ongoing demand for combination therapies like OMECLAMOX-PAK.

Key Market Drivers:

• Rising prevalence of bacterial infections.
• Growing concern over antibiotic resistance, leading to formulations with beta-lactamase inhibitors.
• Expansion in emerging markets with improved healthcare infrastructure.

Competitive Landscape:

• Major players include GlaxoSmithKline, Sandoz, Mylan, and Teva.
• Biosimilar and generic versions will dominate prices, pressuring profit margins.

Fundamental Analysis

Regulatory Pathways and Approvals

• OMECLAMOX-PAK is typically approved under either a full New Drug Application (NDA) or paragraph IV generic entry, depending on patent status.
• In key markets (US, Europe, emerging markets), patent expiration varies, influencing early or late entry.
• Regulatory approval often hinges on bioequivalence to branded products.

Patent and Intellectual Property Status

• Patent expiration occurred for original formulations in most markets between 2015-2020.
• New fixed-dose combinations (FDCs) or formulations may qualify for regulatory exclusivities, often 3-5 years in major jurisdictions.
• Patent challenges are frequent; generic manufacturers may seek ANDA approvals based on bioequivalence.

Manufacturing and Supply Chain

• Production involves combination synthesis with strict quality control for consistency.
• Global supply chain vulnerabilities, especially during pandemics, pose risks to uninterrupted production.
• Economies of scale can significantly reduce manufacturing costs for large-scale producers.

Pricing and Reimbursement

• Generic versions price can be 50-70% lower than branded products.
• Reimbursement policies vary:

Region	Reimbursement Status	Responsible Agencies	Typical Price Difference
US	Medicaid, private insurers	CMS, private insurers	60-70% lower for generics
EU	National health services	Varies across countries	50-70% lower for generics
Emerging Markets	Often limited or out-of-pocket	Local health agencies	Significant variability

Market Entry Timing

• Late patent expiry has increased generic entry, reducing margins for branded producers.
• Early-stage entry involves high regulatory costs but less competition; late entry faces price erosion.

Investment Considerations

Opportunities

• Launching innovative formulations (e.g., sustained-release, combination with other agents) can create differentiation.
• Growing demand in emerging markets offers expansion potential.
• Strategic acquisitions of regional generic producers can improve market penetration.

Risks

• Price erosion due to widespread generic competition.
• Regulatory delays or rejection in certain markets.
• Antibiotic stewardship policies can restrict prescribing practices, impacting sales.
• Increasing antibiotic resistance may reduce efficacy or market size.

Financial Outlook

Metric	Industry Average / Benchmark	Implication for OMECLAMOX-PAK
Gross Margin	60-70% for branded, 50-60% for generics	Branded margins diminish with patent expiry; generics lower margins but higher volume potential
R&D Investment	15-20% of revenue for mid-size firms	Lower for generic-producing firms; primarily manufacturing costs
Market Penetration Potential	High in underserved regions	Elevated with strategic partnerships and localized marketing
Price Decline Post-Patent Expiry	50-70% over 3-5 years	Accelerates generic entry, impacting revenue streams

Strategic Moves

• Focus on markets with regulatory barriers for generics or with delayed patent expiry.
• Invest in quality differentiations and manufacturing efficiencies to maintain profitability.
• Monitor resistance trends and adjust formulations proactively.

Key Takeaways

• OMECLAMOX-PAK operates in a competitive, high-volume antibiotic segment facing imminent or ongoing patent expiries.
• Market growth relies on rising bacterial infection incidence, especially within emerging economies.
• Price erosion from generic competition is a primary profitability risk, countered by potential for formulations innovation or market segmentation strategies.
• Regulatory timelines are variable, influencing go-to-market flexibility.
• Supply chain stability and resistance management are critical factors for sustained market presence.

Frequently Asked Questions

1. What is the typical patent expiry for OMECLAMOX-PAK?
   Patents for amoxicillin-clavulanate formulations generally expired between 2015 and 2020 in major markets, opening the field to generics.

2. How does antibiotic resistance impact OMECLAMOX-PAK sales?
   Resistance can reduce drug efficacy, decreasing demand unless new formulations or combinations mitigate resistance issues.

3. What are the key regulatory hurdles for launching generics of OMECLAMOX-PAK?
   Demonstrating bioequivalence and securing necessary approvals vary by jurisdiction and can delay market entry.

4. Which markets offer the most growth opportunities?
   Emerging markets, including India, Brazil, and parts of Southeast Asia, show high growth due to increased healthcare infrastructure and infection prevalence.

5. How does pricing pressure influence profitability?
   Widespread generic competition drives prices down, compressing margins but increasing sales volumes. Differentiation and efficiency become critical.

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References

[1] Grand View Research. (2021). Antibiotics Market Size, Share & Trends Analysis Report.
[2] US Food and Drug Administration. (2022). Abbreviated New Drug Application (ANDA) Guidance.
[3] European Medicines Agency. (2022). Regulatory framework for antibiotics.
[4] MarketWatch. (2023). Antibiotics Market Outlook and Forecast.
[5] World Health Organization. (2021). Antimicrobial resistance global report.