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Last Updated: December 22, 2024

KLOR-CON Drug Patent Profile


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

Klor-con is a drug marketed by Upsher Smith Labs and is included in four NDAs.

The generic ingredient in KLOR-CON 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

A generic version of KLOR-CON 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

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 potassium chloride CAPSULE, EXTENDED RELEASE;ORAL 203106-001 Jul 10, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upsher Smith Labs KLOR-CON M15 potassium chloride TABLET, EXTENDED RELEASE;ORAL 074726-003 Jun 6, 2003 AB1 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upsher Smith Labs KLOR-CON potassium chloride TABLET, EXTENDED RELEASE;ORAL 019123-001 Apr 17, 1986 AB2 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upsher Smith Labs KLOR-CON M20 potassium chloride TABLET, EXTENDED RELEASE;ORAL 074726-001 Nov 20, 1998 AB1 RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upsher Smith Labs KLOR-CON potassium chloride CAPSULE, EXTENDED RELEASE;ORAL 203106-002 Jul 10, 2015 AB 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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Klor-Con

Introduction

Klor-Con, a potassium chloride extended-release formulation, is a crucial medication for treating and preventing hypokalemia, a condition characterized by low blood potassium levels. Understanding the market dynamics and financial trajectory of Klor-Con involves examining its indications, usage, competition, regulatory environment, and financial performance.

Indications and Usage

Klor-Con is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, particularly in patients where dietary management or diuretic dose reduction is insufficient[1][2][3].

Market Demand

The demand for Klor-Con is driven by several factors:

  • Prevalence of Hypokalemia: Hypokalemia is a common condition, especially among patients with chronic diseases such as heart failure, kidney disease, and those on certain medications like diuretics.
  • Limited Dietary Management: Many patients cannot manage their potassium levels through diet alone, necessitating pharmaceutical intervention.
  • Compliance Issues: Patients who cannot tolerate or refuse liquid or effervescent potassium preparations often rely on extended-release tablets like Klor-Con[3].

Competitive Landscape

The market for potassium supplements is competitive, with various formulations available:

  • Liquid and Effervescent Preparations: These are often preferred due to better tolerance but may have compliance issues.
  • Extended-Release Tablets: Klor-Con competes with other extended-release formulations, including wax matrix and microencapsulated products. Each type has its advantages and potential risks, such as gastrointestinal irritation and ulceration[3][5].
  • Generic and Branded Products: The presence of generic potassium chloride products can impact the market share of branded products like Klor-Con.

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics of Klor-Con:

  • FDA Approval: Initially approved in 1948, Klor-Con has undergone various updates and revisions to its prescribing information[1][2].
  • Contraindications and Warnings: The drug has specific contraindications, such as concomitant use with triamterene and amiloride, and warnings regarding gastrointestinal irritation and the risk of hyperkalemia[1][3][5].
  • Geriatric and Pediatric Use: Special considerations are necessary for elderly and pediatric patients, including cautious dose selection and monitoring of renal function[1][2][3].

Financial Performance

The financial trajectory of Klor-Con can be influenced by several factors:

  • Sales and Revenue: The drug's sales are driven by its prescription volume, which is affected by its efficacy, safety profile, and physician preference.
  • Pricing Strategies: The pricing of Klor-Con is competitive, with generic alternatives available. This can impact the revenue generated by the branded product.
  • Market Share: Klor-Con's market share within the potassium supplement market is crucial. It competes with other formulations and brands, and its share can fluctuate based on clinical outcomes, patient compliance, and healthcare provider recommendations.

Cost and Reimbursement

The cost and reimbursement landscape is vital for the financial health of Klor-Con:

  • Health Insurance Coverage: The drug's coverage by health insurance plans, including Medicare and private insurers, significantly affects its prescription rates and revenue. Policies often require specific criteria to be met for approval, such as a diagnosis of hypokalemia and inability to use other formulations[4].
  • Out-of-Pocket Costs: For patients without adequate insurance coverage, the out-of-pocket cost can be a barrier to access, impacting sales.

Clinical Outcomes and Safety Profile

The safety profile and clinical outcomes of Klor-Con are critical for its market success:

  • Gastrointestinal Risks: The drug is associated with gastrointestinal risks such as ulceration, bleeding, and obstruction. These risks can affect patient compliance and physician prescribing habits[3][5].
  • Hyperkalemia Risk: The potential for hyperkalemia, especially in patients with impaired renal function, requires careful monitoring and can impact the drug's usage[1][3].

Innovations and Future Developments

Innovations in formulation and delivery can influence the market dynamics:

  • Microencapsulated Formulations: Newer formulations like Klor-Con M, which use microencapsulated potassium chloride crystals, offer different release profiles and may have fewer gastrointestinal side effects[5].
  • Patient Compliance: Improvements in patient compliance, such as easier-to-swallow tablets or better-tolerated formulations, can enhance market performance.

Key Takeaways

  • Market Demand: Driven by the prevalence of hypokalemia and the need for pharmaceutical intervention.
  • Competitive Landscape: Competitive with various potassium supplement formulations.
  • Regulatory Environment: Subject to FDA regulations and specific contraindications and warnings.
  • Financial Performance: Influenced by sales volume, pricing strategies, and market share.
  • Clinical Outcomes: Safety profile and clinical outcomes are crucial for market success.

FAQs

1. What is Klor-Con used for? Klor-Con is used for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management is insufficient.

2. What are the common side effects of Klor-Con? Common side effects include nausea, vomiting, flatulence, abdominal pain, and diarrhea. Severe side effects can include gastrointestinal ulceration, bleeding, and hyperkalemia.

3. How should Klor-Con be administered? Klor-Con should be taken with meals and a glass of water or other liquid. The tablets should be swallowed whole without crushing, chewing, or sucking.

4. What are the contraindications for Klor-Con? Klor-Con is contraindicated in patients on triamterene and amiloride.

5. How does the geriatric use of Klor-Con differ from younger patients? Dose selection for elderly patients should be cautious, starting at the low end of the dosing range due to potential decreased hepatic, renal, or cardiac function.

Cited Sources

  1. Drugs.com - Klor-Con: Package Insert / Prescribing Information
  2. FDA - KLOR CON - accessdata.fda.gov
  3. RxList - Klor-Con (Potassium Chloride): Side Effects, Uses, Dosage
  4. Superior Health Plan - Potassium Chloride for Oral Solution (Klor-Con Powder)
  5. DailyMed - KLOR-CON M - potassium chloride tablet, extended release

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