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Last Updated: December 22, 2024

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-seven 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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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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

KLOR-CON M15 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for KLOR-CON M15

Introduction

KLOR-CON M15 is an extended-release oral dosage form of potassium chloride, designed to replenish potassium in the body. This medication is crucial for patients suffering from hypokalemia or those at risk of potassium depletion. Here, we will delve into the market dynamics and financial trajectory of KLOR-CON M15.

Market Demand and Patient Needs

The demand for potassium chloride supplements like KLOR-CON M15 is driven by the prevalence of conditions that lead to potassium deficiency. Hypokalemia, a condition characterized by low potassium levels, can result from various factors including certain medications, gastrointestinal disorders, and excessive sweating. The need for effective and safe potassium replenishment therapies is constant, making KLOR-CON M15 a valuable product in the healthcare market[1][3][5].

Competitive Landscape

The market for potassium chloride supplements is competitive, with various formulations available, including immediate release, sustained release, and extended release. KLOR-CON M15 stands out due to its unique microencapsulated extended-release formulation, which minimizes the risk of gastrointestinal lesions compared to other types of formulations like enteric-coated or wax matrix tablets[1][3][5].

Regulatory Environment

KLOR-CON M15 is approved under an Abbreviated New Drug Application (ANDA) and is classified as a prescription drug. The regulatory environment is stringent, with the FDA overseeing the manufacturing, labeling, and marketing of the drug. Compliance with FDA guidelines is crucial for maintaining market presence and ensuring patient safety[3].

Dosage and Pricing

KLOR-CON M15 is available in various strengths, including 10 mEq, 15 mEq, and 20 mEq of potassium per tablet. The pricing of KLOR-CON M15 can vary based on the strength, quantity, and the pharmacy or healthcare provider. Generally, prescription medications like KLOR-CON M15 are covered by insurance plans, which can influence their financial trajectory by making them more accessible to patients[1][4][5].

Distribution and Supply Chain

KLOR-CON M15 is distributed by Upsher-Smith Laboratories and is available in various packaging options, including bottles of 90, 100, and 1,000 tablets, as well as unit-dose cartons. The supply chain is managed to ensure consistent availability of the medication to meet patient demand[1][4].

Financial Performance

The financial performance of KLOR-CON M15 is influenced by several factors, including market demand, competition, pricing strategies, and regulatory compliance. Here are some key points:

  • Revenue Generation: The revenue from KLOR-CON M15 is substantial due to its widespread use in managing hypokalemia. The extended-release formulation and the lack of enteric coating or wax matrix reduce the risk of gastrointestinal complications, making it a preferred choice for many healthcare providers.
  • Cost Structure: The cost of producing KLOR-CON M15 includes the cost of active and inactive ingredients, manufacturing, packaging, and distribution. The microencapsulation process, while beneficial, may add to the production costs.
  • Market Share: KLOR-CON M15 holds a significant market share in the potassium chloride supplement market due to its safety profile and efficacy. The brand's reputation and the trust of healthcare providers contribute to its financial stability.

Growth Prospects

The growth prospects for KLOR-CON M15 are positive due to several factors:

  • Increasing Prevalence of Hypokalemia: As the population ages and the incidence of conditions leading to potassium deficiency increases, the demand for KLOR-CON M15 is likely to rise.
  • Advancements in Formulation: Continuous improvements in the formulation and delivery system can enhance patient compliance and safety, further boosting market demand.
  • Expanding Healthcare Coverage: Increased healthcare coverage and insurance plans that include prescription medications like KLOR-CON M15 can expand its market reach.

Challenges and Risks

Despite the positive outlook, there are challenges and risks associated with KLOR-CON M15:

  • Regulatory Changes: Changes in FDA regulations or guidelines can impact the manufacturing and marketing of KLOR-CON M15.
  • Competitive Pressure: The entry of new competitors or generic versions of potassium chloride supplements can erode market share.
  • Adverse Reactions: Although rare, severe gastrointestinal reactions can occur, which may affect patient trust and market dynamics[1][3][5].

Clinical and Economic Impact

KLOR-CON M15 has a significant clinical and economic impact:

  • Clinical Benefits: The extended-release formulation helps in maintaining stable potassium levels, reducing the risk of hypokalemia and its complications.
  • Economic Benefits: By preventing hospitalizations and reducing the need for emergency treatments due to potassium deficiency, KLOR-CON M15 can lower healthcare costs in the long run.

Key Takeaways

  • Market Demand: Driven by the prevalence of hypokalemia and the need for safe potassium replenishment.
  • Competitive Advantage: Unique microencapsulated extended-release formulation.
  • Regulatory Compliance: Crucial for maintaining market presence.
  • Financial Performance: Influenced by demand, competition, pricing, and regulatory compliance.
  • Growth Prospects: Positive due to increasing prevalence of hypokalemia and advancements in formulation.

FAQs

Q: What is the active ingredient in KLOR-CON M15? A: The active ingredient in KLOR-CON M15 is potassium chloride[1][3][5].

Q: How does KLOR-CON M15 differ from other potassium chloride supplements? A: KLOR-CON M15 is an immediately dispersing extended-release oral dosage form containing microencapsulated potassium chloride, which reduces the risk of gastrointestinal lesions compared to other formulations[1][3][5].

Q: What are the common dosages of KLOR-CON M15? A: KLOR-CON M15 is available in 10 mEq, 15 mEq, and 20 mEq strengths[1][4][5].

Q: What are the potential side effects of KLOR-CON M15? A: Potential side effects include severe vomiting, abdominal pain, distention, or gastrointestinal bleeding. These symptoms require immediate medical attention[1][3][5].

Q: Is KLOR-CON M15 covered by insurance? A: Yes, KLOR-CON M15 is typically covered by insurance plans, making it more accessible to patients[1][4].

Sources

  1. DailyMed: KLOR-CONĀ® M Potassium Chloride Extended-Release Tablets, USP.
  2. Internet Archive: The Daily Colonist (1971-12-03).
  3. DailyMed: KLOR-CON M- potassium chloride tablet, extended release.
  4. PharmaCompass: Klor-Con | Drug Information, Uses, Side Effects, Chemistry.
  5. DailyMed: KLOR-CONĀ® M Potassium Chloride Extended-release Tablets, USP.

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