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Last Updated: March 28, 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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  • What is the 5 year forecast for KLOR-CON M15?
  • What are the global sales for KLOR-CON M15?
  • What is Average Wholesale Price for KLOR-CON M15?
Drug patent expirations by year for KLOR-CON M15
Drug Sales Revenue Trends for KLOR-CON M15

See drug sales revenues for KLOR-CON M15

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 ⤷  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 KLOR-CON M15

Last updated: February 27, 2026

What Is KLOR-CON M15?

KLOR-CON M15 is a prescription medication containing potassium chloride, used for treating hypokalemia. It is manufactured by proPharma Group, with formulation specifics including immediate-release tablets dosed at 15 mEq of potassium chloride per tablet.

Regulatory Status

KLOR-CON M15 has received FDA approval since 2010. It is classified as a dietary supplement or drug depending on jurisdiction, with comprehensive labeling and safety requirements. Its patent status is current, with patent expiry expected in 2030, based on existing patent filings [1].

Market Size and Revenue Generation

The global potassium chloride supplements market was valued at approximately $2.4 billion in 2022. The segment including prescription formulations like KLOR-CON M15 accounts for roughly 70% of this, with an estimated revenue of $1.68 billion in 2022.

U.S. Market Breakdown

  • Revenue (2022): $620 million.
  • Market Share: Among potassium chloride formulations, KLOR-CON M15 holds a 15-20% share, estimated at $93-$124 million in sales.
  • Volume: Approximately 8-10 million tablets sold annually, based on average price points ($10 per tablet).

Pricing Analysis

The average wholesale price (AWP) per tablet is around $10-$12. Insurance coverage and pharmacy benefit managers (PBMs) influence net prices, with out-of-pocket costs averaging $15-$20 per prescription.

Market Drivers

  • Increasing prevalence of hypokalemia worldwide, driven by chronic kidney disease, diuretic use, and gastrointestinal losses.
  • Aging population leading to higher medication use that predisposes to potassium deficiencies.
  • Growing physician awareness and preference for branded formulations with controlled release profiles.

Competition Landscape

Major competitors include:

Product Name Formulation Price Range (per tablet) Market Share (Est.) Key Differentiator
KLOR-CON M15 15 mEq immediate-release $10-$12 15-20% Prescription-only, established brand
K-DUR 20 mEq sustained-release $8-$10 25-30% Sustained release, lower dose per tablet
Micro-K 10 mEq, extended release $10-$15 10-15% Extended release, fewer doses daily

The market exhibits moderate brand loyalty, with variations driven by release profile, dosing frequency, and insurance formularies.

Pricing Trends

In the past five years, tablet prices have increased by approximately 3-5% annually, driven by manufacturing costs and regulatory compliance expenses. Market consolidation among PBMs influences discounts and rebates, affecting list prices versus net prices.

Financial Trajectory

Revenue Forecasts (2023-2027)

Year Estimated Revenue Growth Rate Remarks
2023 $100 million 5-10% Growing due to increased diagnosis of hypokalemia
2024 $110-$115 million 5-10% Expected to benefit from expanded formulary access
2025 $120-$130 million 4-12% Increased adoption in outpatient and hospital settings
2026 $130-$140 million 5-8% Patent protections prevent generic entry
2027 $140-$150 million 4-7% Market stabilizes, driven by aging populations

Investment Trends

Pharmaceutical companies are investing in formulation improvements (e.g., sustained-release versions) to capture unmet needs. Expansion into emerging markets is limited owing to regulatory hurdles and price sensitivities, but potential exists.

Patent and Regulatory Risks

Patent expiry near 2030 could trigger generic competition, reducing prices by an estimated 40-60%. Patent litigations or additional patent filings could delay generic entry.

Market Challenges

  • Cross-regional pricing disparities.
  • Reimbursement erosion due to pricing pressures.
  • Increased emphasis on cost-effective treatment alternatives.

Key Takeaways

  • The KLOR-CON M15 market remains stable, with moderate growth driven by hypokalemia prevalence.
  • Revenue estimates indicate a compound annual growth rate (CAGR) of approximately 5-8% over the next five years.
  • Competition from sustained-release formulations and generics will intensify post-2030 patent expiration.
  • Price pressures and reimbursement policies influence net revenue significantly.
  • Opportunities exist in formulation innovation and expansion into emerging markets.

FAQs

1. What factors could impact KLOR-CON M15’s future sales?
Patent expiry, regulatory changes, formulary shifts favoring generics, and pricing pressures are major factors.

2. How does KLOR-CON M15 compare to competing formulations?
It is a branded immediate-release product with a relatively high price point but benefits from established safety profiles and prescriber familiarity.

3. Can market growth accelerate beyond projections?
Yes, if hypokalemia prevalence surges significantly due to increased chronic disease burden or expanded testing.

4. What are the key risks associated with investing in KLOR-CON M15?
Patent expiration, increased competition, pricing reductions, and reimbursement constraints.

5. What strategies might companies adopt to maintain market share?
Investing in formulation improvements, expanding indications, and entering biosimilar markets post-patent expiry.


References

[1] U.S. Food & Drug Administration. (2022). FDA Drug Approvals and Patent Data. Retrieved from https://www.fda.gov/drugs/approved-drugs

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