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Last Updated: December 22, 2024

KLOR-CON M20 Drug Patent Profile


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When do Klor-con M20 patents expire, and when can generic versions of Klor-con M20 launch?

Klor-con M20 is a drug marketed by Upsher Smith Labs and is included in one NDA.

The generic ingredient in KLOR-CON M20 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 M20

A generic version of KLOR-CON M20 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 M20

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 M20 potassium chloride TABLET, EXTENDED RELEASE;ORAL 074726-001 Nov 20, 1998 AB1 RX No Yes ⤷  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 M20 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Klor-Con M20

Introduction to Klor-Con M20

Klor-Con M20 is a medication used to treat and prevent low levels of potassium in the blood, a condition known as hypokalemia. It contains potassium chloride, an essential mineral for various bodily functions, including heart, muscle, and nerve function[1][4][5].

Market Demand and Patient Needs

The demand for Klor-Con M20 is driven by the prevalence of hypokalemia, which can arise from various factors such as medication side effects (e.g., diuretics), certain medical conditions (e.g., kidney disease, heart failure), and dietary deficiencies. The need for effective potassium supplements is consistent, making Klor-Con M20 a staple in many healthcare settings.

Competitive Landscape

The market for potassium supplements is relatively stable, with several brands offering similar formulations. Klor-Con M20 competes with other extended-release potassium chloride products, such as Micro-K and K-Dur. The competitive landscape is influenced by factors such as product formulation, pricing, and brand reputation. Klor-Con M20's unique microencapsulated formulation, which provides an extended release of potassium, is a key differentiator[2][4].

Regulatory Environment

Klor-Con M20 is approved by the FDA as an extended-release oral dosage form of potassium chloride. Regulatory compliance is crucial, and the product must adhere to strict guidelines regarding manufacturing, labeling, and safety monitoring. The FDA's oversight ensures that the product meets high standards of quality and safety[2][3].

Pricing and Reimbursement

The pricing of Klor-Con M20 is influenced by various factors, including production costs, market competition, and reimbursement policies. In the United States, the cost of Klor-Con M20 can vary depending on the pharmacy and the patient's insurance coverage. Generally, it is covered by most health insurance plans, which helps maintain a stable market demand[5].

Distribution and Accessibility

Klor-Con M20 is widely available through various distribution channels, including pharmacies, hospitals, and online retailers. Its accessibility is enhanced by its inclusion in many formularies and its availability in different packaging options, such as bottles and unit-dose cartons[4].

Financial Performance

The financial performance of Klor-Con M20 is tied to its market share and sales volume. As a well-established product, it generates significant revenue for its manufacturers. Here are some key financial indicators:

  • Revenue Growth: The revenue from Klor-Con M20 has been relatively stable over the years, driven by consistent demand for potassium supplements.
  • Market Share: Klor-Con M20 holds a significant market share in the potassium supplement market, competing effectively with other brands.
  • Cost Structure: The cost structure includes manufacturing costs, marketing expenses, and regulatory compliance costs. The extended-release formulation and microencapsulation process contribute to the product's cost[2][4].

Key Challenges and Opportunities

Challenges

  • Side Effects and Safety Concerns: Despite its benefits, Klor-Con M20 can cause gastrointestinal side effects and other serious complications, such as esophageal ulceration in certain patients. Managing these risks is crucial for maintaining market confidence[2][5].
  • Regulatory Changes: Changes in regulatory requirements can impact the product's approval and market availability.
  • Generic Competition: The potential for generic versions of potassium chloride supplements could affect the market share and pricing of Klor-Con M20.

Opportunities

  • Expanding Indications: There is potential for expanding the indications for Klor-Con M20 to include other conditions related to potassium deficiency.
  • International Markets: Entering international markets can provide new revenue streams.
  • Innovative Formulations: Continuous innovation in formulation and delivery methods can help maintain a competitive edge.

Impact of Economic Factors

Economic factors such as healthcare spending, insurance coverage, and patient out-of-pocket costs influence the demand for Klor-Con M20. Economic downturns can affect healthcare spending, but essential medications like Klor-Con M20 tend to remain in demand due to their critical role in patient care.

Technological Advancements

Technological advancements in pharmaceutical manufacturing and drug delivery systems can enhance the efficacy and safety of Klor-Con M20. For example, improvements in microencapsulation technology can further optimize the release of potassium chloride, reducing the risk of side effects and improving patient compliance[2][4].

Consumer Behavior and Awareness

Consumer awareness about the importance of potassium in health and the risks associated with hypokalemia drives the demand for Klor-Con M20. Educational campaigns and healthcare provider recommendations play a significant role in shaping consumer behavior and increasing product adoption.

Key Takeaways

  • Stable Demand: Klor-Con M20 benefits from consistent demand due to the prevalence of hypokalemia.
  • Competitive Market: The product competes in a stable market with other potassium supplements.
  • Regulatory Compliance: Adherence to FDA regulations is crucial for maintaining market approval.
  • Financial Stability: The product generates significant revenue, with a stable cost structure.
  • Challenges and Opportunities: Managing side effects, regulatory changes, and generic competition are key challenges, while expanding indications and entering international markets offer opportunities.

FAQs

Q: What is Klor-Con M20 used for? A: Klor-Con M20 is used to treat and prevent low levels of potassium in the blood, a condition known as hypokalemia[1][4][5].

Q: How should Klor-Con M20 be taken? A: Klor-Con M20 should be taken by mouth with a meal and a full glass of water to minimize stomach upset. The tablets should not be crushed, chewed, or sucked on[1][4][5].

Q: What are the common side effects of Klor-Con M20? A: Common side effects include gastrointestinal symptoms such as nausea, vomiting, diarrhea, and abdominal discomfort. Serious side effects can include severe allergic reactions and irregular heartbeat[1][5].

Q: Can Klor-Con M20 interact with other medications? A: Yes, Klor-Con M20 can interact with medications that slow down the movement of potassium in the stomach or intestines, such as certain antihistamines and antispasmodic drugs[5].

Q: Is Klor-Con M20 safe for patients with kidney problems? A: Patients with kidney problems should use Klor-Con M20 with caution, as impaired kidney function can affect how the body handles potassium[1][2].

Cited Sources

  1. Qwark Health: Klor-Con M20 - Qwark Health
  2. DailyMed: KLOR-CON M- potassium chloride tablet, extended release - DailyMed
  3. FDA Administrative Documents: 74726 KLOR-CON Administrative Documents - accessdata.fda.gov
  4. DailyMed: KLOR-CONĀ® M Potassium Chloride Extended-Release Tablets ...
  5. WebMD: Klor-Con M20 Oral: Uses, Side Effects, Interactions ... - WebMD

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