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Last Updated: January 20, 2025

KLOTRIX Drug Patent Profile


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When do Klotrix patents expire, and what generic alternatives are available?

Klotrix is a drug marketed by Apothecon and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Klotrix

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

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Summary for KLOTRIX
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 314
Patent Applications: 2,381
DailyMed Link:KLOTRIX at DailyMed
Drug patent expirations by year for KLOTRIX

US Patents and Regulatory Information for KLOTRIX

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Apothecon KLOTRIX potassium chloride TABLET, EXTENDED RELEASE;ORAL 017850-001 Approved Prior to Jan 1, 1982 DISCN 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
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Klotrix (Potassium Chloride)

Introduction

Klotrix, a brand name for the electrolyte replenisher potassium chloride, has been a part of the pharmaceutical market, although its brand name has been discontinued in the U.S. This article will delve into the market dynamics and financial trajectory of Klotrix, exploring its usage, pricing, and the broader context of the pharmaceutical industry.

Description and Usage of Klotrix

Klotrix is a solid, oral dosage form of potassium chloride, containing 750 mg of potassium chloride (equivalent to 10 mEq of potassium) in a film-coated wax-matrix tablet. This formulation is designed to provide a controlled release of potassium to minimize the risk of high, localized concentrations within the gastrointestinal tract[1].

Clinical Indications

Klotrix is used for the treatment of patients with hypokalemia, with or without metabolic alkalosis, and in cases of digitalis intoxication. It is also prescribed for patients with hypokalemic familial periodic paralysis. The drug is particularly recommended for patients who cannot tolerate or refuse to take liquid or effervescent potassium preparations[1].

Market Position and Discontinuation

Despite its clinical utility, the Klotrix brand name has been discontinued in the U.S. However, generic versions of potassium chloride may still be available, approved by the FDA. This discontinuation affects the brand's market presence but does not eliminate the availability of the generic equivalent[1].

Pricing and Cost Considerations

The cost of Klotrix, or its generic equivalents, can vary based on several factors, including the patient's insurance coverage and the specific formulation. Generally, potassium chloride is less expensive compared to many other prescription medications. For instance, the cost of a generic potassium chloride supplement can range widely but is typically more affordable than branded or specialized medications[5].

Insurance Coverage and Out-of-Pocket Costs

Insurance coverage plays a significant role in determining the out-of-pocket costs for patients. While specific data on Klotrix is limited due to its discontinuation, generic potassium chloride supplements are often covered by various insurance plans. Patients with commercial insurance or Medicare may have different out-of-pocket costs, which can be reduced through supplemental insurance or manufacturer co-pay assistance programs[2].

Gastrointestinal Risks and Safety Considerations

One of the critical market dynamics affecting Klotrix is the risk of gastrointestinal lesions associated with solid oral dosage forms of potassium chloride. These risks include ulcerative and stenotic lesions, particularly with enteric-coated preparations. The wax-matrix formulation of Klotrix is designed to mitigate these risks, but it remains a significant concern that influences prescribing decisions and patient compliance[1].

Dosage and Administration

The dosage of Klotrix must be adjusted to individual patient needs, typically ranging from 20 mEq per day for prevention to 40-100 mEq per day or more for treatment. The drug should be taken with meals and a glass of water to minimize gastric irritation. This specific administration requirement can impact patient adherence and overall market acceptance[1].

Broader Pharmaceutical Market Context

The pharmaceutical market is influenced by several factors, including research and development costs, regulatory frameworks, and competition from generics. The Hatch-Waxman Act and the Biologics Price Competition and Innovation Act have facilitated generic entry into the market, reducing patent-related barriers and promoting competition. However, obstacles such as contractual relationships between intermediaries, manufacturers, and health plan sponsors can affect prices and competition[4].

Economic Implications of Precision Medicines

The shift towards precision medicines, which target smaller patient populations, has significant economic implications. Drugs like Kalydeco, which treat specific mutations in cystic fibrosis patients, illustrate how high prices can be justified for small patient populations due to the high value created per patient. This trend may influence the development and pricing strategies for other medications, including those like Klotrix, although it is not a precision medicine itself[3].

Financial Trajectory

The financial trajectory of Klotrix, or its generic equivalents, is influenced by several factors:

  • Generic Competition: The availability of generic potassium chloride supplements keeps prices relatively low and stable.
  • Regulatory Environment: The regulatory framework supports generic entry, which maintains competitive pricing.
  • Patient Compliance: The risk of gastrointestinal side effects can affect patient compliance and, consequently, the drug's market performance.
  • Insurance Coverage: The extent of insurance coverage and out-of-pocket costs significantly impact the financial burden on patients and the overall market demand.

Key Takeaways

  • Discontinuation of Brand Name: The Klotrix brand name has been discontinued, but generic equivalents remain available.
  • Clinical Utility: Klotrix is used for treating hypokalemia and related conditions.
  • Pricing and Cost: Generally affordable, with costs influenced by insurance coverage.
  • Safety Considerations: Risks of gastrointestinal lesions are a significant concern.
  • Broader Market Context: Influenced by regulatory frameworks, generic competition, and the trend towards precision medicines.

FAQs

What is Klotrix used for?

Klotrix is used for the treatment of patients with hypokalemia, with or without metabolic alkalosis, and in cases of digitalis intoxication and hypokalemic familial periodic paralysis.

Why has the Klotrix brand name been discontinued?

The Klotrix brand name has been discontinued in the U.S., but generic versions of potassium chloride may still be available.

What are the risks associated with taking Klotrix?

Klotrix can produce ulcerative and stenotic lesions of the gastrointestinal tract, particularly if not taken as directed.

How does insurance coverage affect the cost of Klotrix?

Insurance coverage significantly impacts the out-of-pocket costs for patients. Those with commercial insurance or Medicare may have different costs, which can be reduced through supplemental insurance or co-pay assistance programs.

What is the typical dosage of Klotrix?

The dosage of Klotrix must be adjusted to individual patient needs, typically ranging from 20 mEq per day for prevention to 40-100 mEq per day or more for treatment.

Sources

  1. Drugs.com: Klotrix: Package Insert / Prescribing Information.
  2. Keytruda.com: Cost, Insurance, & Financial Help With KEYTRUDA® (pembrolizumab).
  3. NBER.org: The Economics of Drug Development: Pricing and Innovation in a Changing Market.
  4. FTC.gov: Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.
  5. BlinkHealth.com: Buy Klotrix (potassium chloride) Online.

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