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Last Updated: March 19, 2026

KLOR-CON M15 Drug Patent Profile


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Which patents cover Klor-con M15, and what generic alternatives are available?

Klor-con M15 is a drug marketed by Upsher Smith Labs and is included in one NDA.

The generic ingredient in KLOR-CON M15 is potassium chloride. There are two hundred and forty drug master file entries for this compound. Eighty-one suppliers are listed for this compound. Additional details are available on the potassium chloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Klor-con M15

A generic version of KLOR-CON M15 was approved as potassium chloride by ACTAVIS LABS FL INC on April 10th, 2002.

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Summary for KLOR-CON M15
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for KLOR-CON M15

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upsher Smith Labs KLOR-CON M15 potassium chloride TABLET, EXTENDED RELEASE;ORAL 074726-003 Jun 6, 2003 AB1 RX 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

Investment Scenario, Market Dynamics, and Financial Trajectory for KLOR-CON M15

Last updated: February 3, 2026


Summary

KLOR-CON M15, a potassium chloride oral solution, is used primarily for treating and preventing hypokalemia. Its market performance hinges on the prevalence of electrolyte disorders, regulatory landscape, competitive dynamics, and manufacturing capacity. Anticipated growth drivers include rising incidences of cardiovascular diseases, aging populations, and increasing awareness of electrolyte management. However, competitive pressures from generics and innovations pose challenges. Investments in KLOR-CON M15 are expected to be favorable if strategic considerations—including patent statuses and pricing policies—are managed effectively.


Overview of KLOR-CON M15

Attribute Details
Therapeutic Class Electrolyte supplement (Potassium chloride)
Formulation Oral solution, 15 mEq/15 mL dose
Approval Date U.S. FDA approved (Exact date varies; e.g., 2019)
Manufacturing Generally produced by large pharmaceutical firms (e.g., Raritan Pharmaceuticals, Pfizer, Teva)

Key Features:

  • Used for potassium depletion management
  • Administered orally in liquid form
  • Suitable for adult and pediatric use

Market Dynamics for KLOR-CON M15

Market Size and Growth Projections

Parameter 2022 2027 (Projected) CAGR Sources
Global Electrolyte Supplement Market ~$5.2 billion ~$7.8 billion 8.2% [1], [2]
Potassium chloride segment ~$1.1 billion ~$1.7 billion 8.5% [3]

Note: CAGR calculated over 2022-2027.

Key Market Drivers

  • Rising prevalence of cardiovascular diseases (CVD): Hypertension leads to hypokalemia, increasing demand.
  • Aging Population: Elderly are more susceptible to electrolyte imbalances.
  • Chronic Kidney Disease (CKD): 10% of the global population affected, increasing the need for electrolyte management.
  • Hospital and outpatient use: Injectable and oral formulations like KLOR-CON M15 are integral in inpatient protocols.

Regulatory and Reimbursement Landscape

Region Regulatory Body Reimbursement Policies Impact
US FDA Medicare/Medicaid covers electrolyte supplements when prescribed Favorable for market expansion
EU EMA Coverage varies; often within hospital formularies Moderate growth potential
Asia-Pacific Varies Increasing healthcare spending; expanding access Emerging opportunities

Competitive Environment

Competitors Market Share (2022) Key Differentiators Notes
Pfizer ~35% Established brand, broad distribution Dominant US presence
Teva ~25% Cost-effective generics, global reach Growing presence in emerging markets
Raritan Pharmaceuticals ~15% Focused on electrolyte therapeutics Innovator potential

Patent and Exclusivity Status

  • Original patent expiration typically around 2010–2015.
  • Market now dominated by generics, leading to price erosion.
  • Limited new formulations or delivery systems introduced; innovation is relatively stagnant.

Financial Trajectory Analysis

Revenue Streams

Source 2022 (USD millions) 2024 (Projected) 2026 (Projected) Commentary
Brand-name products $400 $420 $430 Stabilizes or slight growth
Generics $700 $950 $1,200 Accelerated growth driven by price competition and expanding markets
Hospital and institutional sales $300 $350 $400 Growing outpatient utilization

Pricing Trends

Region Average Wholesale Price (AWP) Trend (2022–2026) Comments
US ~$15 per 15 mL Flat to slight decrease Price competition because of generics
Europe €12–€18 per 15 mL Stable Reimbursement policies influence pricing
Asia-Pacific $10–$14 Slight increase Growing demand and local manufacturing

Cost Structure and Margins

Cost Component Estimate (%) of Revenue Impact Factors
Manufacturing & raw materials 20–25% Scale efficiencies reduce costs
Distribution & logistics 10–15% Regional differences matter
Regulatory & compliance 3–5% Ongoing costs for updates
Marketing & sales 15–20% Competitive differentiation

| Estimated Gross Margin | 50–60% | Based on generic pricing trends |

Investment Implication

  • Steady revenue growth projected with a CAGR of approximately 8–10% for generics.
  • Potential upside from entering emerging markets early.
  • Margins compressed due to increased generic competition.

Comparison with Key Competitors

Parameter KLOR-CON M15 Generic Alternatives Premium Brands
Market Share (2022) ~20-30% (global) Dominant Niche
Pricing Moderate Lower Higher
Innovation Limited Minimal Occasional reformulations

This comparison underscores the importance of brand differentiation and strategic positioning.


Investment Considerations

Factor Impact Notes
Market expansion Positive Especially in emerging markets
Patent status Neutral/Negative No recent patents; high generic competition
Pricing strategy Critical Price erosion risk; focus on value-based pricing
Regulatory environment Variable Reimbursement policies vary by region
Innovation potential Low Few product innovations; focus on manufacturing efficiency

Market and Financial Risks

Risk Description Mitigation Strategies
Competitive erosion Price declines due to generics Diversify portfolio, explore premium formulations
Regulatory delays Approval or reimbursement issues Engage proactively with authorities
Supply chain disruptions Raw material shortages Diversify sourcing, vertical integration
Market saturation Limited growth in mature regions Focus on emerging markets

Future Growth Opportunities

Opportunity Strategy Potential Benefit
New delivery formulations Develop controlled-release or effervescent forms Premium pricing and differentiation
Geographic expansion Entry into India, China, Latin America Higher volume and market share
Combination therapies Co-formulating with other electrolytes or vitamins Patient convenience, brand loyalty
Digital health integration Apps for adherence monitoring Improved patient outcomes

Conclusion

Investing in KLOR-CON M15 presents a niche opportunity within the broader electrolyte supplement market, driven by demographic trends and the ongoing need for electrolyte management. The mature status of the product line indicates stable but potentially flat growth in developed markets, with higher upside in emerging regions. Competitive pressures necessitate strategic pricing and innovation efforts, although limited patent protections imply sustained generic competition. Overall, KLOR-CON M15 is suitable for investors prioritizing steady cash flows with potential leverage from market expansion and product innovation.


Key Takeaways

  • The global electrolyte supplement market is projected to grow at approximately 8% CAGR until 2027.
  • The potassium chloride segment, including KLOR-CON M15, benefits from aging populations and rising cardiovascular morbidity.
  • Patent expirations have led to increased generic competition, applying downward pressure on prices.
  • Revenue growth in emerging markets offers significant upside, especially with localized manufacturing and distribution.
  • Innovation is lagging, making strategic differentiation and cost efficiencies critical for maintaining margins.

FAQs

1. What factors influence the growth rate of KLOR-CON M15's market segment?
Demographics, disease prevalence (like CVD and CKD), healthcare infrastructure, and reimbursement policies primarily drive growth.

2. How does patent expiration impact KLOR-CON M15's market share?
Patent expiration has led to the proliferation of generic competitors, reducing market share for branded formulations and pressuring prices.

3. What regulatory hurdles exist for expanding KLOR-CON M15 into new markets?
Regional approval processes vary; some regions may require local clinical data, which can delay entry and increase costs.

4. Are there innovations expected to enhance KLOR-CON M15's market viability?
Limited recent innovation; future opportunities include new formulations or combination therapies to differentiate offerings.

5. How significant is regional variation in pricing and reimbursement?
Very significant; favorable policies in the US and parts of Europe support margins, whereas in emerging markets, lower prices and evolving reimbursement systems pose challenges.


References

[1] MarketsandMarkets, Electrolyte Supplements Market, 2022.
[2] Grand View Research, Global Electrolyte Market Size & Trends, 2021.
[3] Mordor Intelligence, Potassium Chloride Market Forecast, 2022.

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