Last Updated: August 9, 2026

POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER Drug Patent Profile


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When do Potassium Chloride 30meq In Plastic Container patents expire, and when can generic versions of Potassium Chloride 30meq In Plastic Container launch?

Potassium Chloride 30meq In Plastic Container is a drug marketed by Baxter Hlthcare and Otsuka Icu Medcl and is included in two NDAs.

The generic ingredient in POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER is potassium chloride. There are two hundred and forty drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the potassium chloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Potassium Chloride 30meq In Plastic Container

A generic version of POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER 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 POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER?
  • What are the global sales for POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER?
Summary for POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
Pharmacology for POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER

US Patents and Regulatory Information for POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER potassium chloride INJECTABLE;INJECTION 019904-003 Dec 26, 1989 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Otsuka Icu Medcl POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER potassium chloride INJECTABLE;INJECTION 020161-003 Aug 11, 1998 DISCN Yes 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 Potassium Chloride 30 mEq in Plastic Container

Last updated: March 22, 2026

What Drives the Market for Potassium Chloride 30 mEq?

The potassium chloride 30 mEq in plastic containers primarily targets clinical settings for potassium replacement therapy. It functions as a key electrolyte supplement for patients with hypokalemia caused by conditions such as renal disease, diuretic use, or gastrointestinal losses.

Market Drivers:

  • Growing Prevalence of Hypokalemia: Estimated global hypokalemia incidence ranges from 20% to 60% among hospitalized patients (Sezer et al., 2020). This increases demand for potassium chloride formulations.
  • Expanding Hospital Admissions: An annual increase of 4.5% in hospitalizations in developed regions heightens utilization of electrolyte replenishment products.
  • Rising Chronic Kidney Disease (CKD): CKD affects approximately 10% of the world population, driving frequent electrolyte management needs.
  • Labeling and Administration Preference: Plastic containers provide safety and ease of handling compared to glass, aligning with safety regulations.
  • Regulatory Approvals: Regulatory bodies like the FDA and EMA have approved potassium chloride products, facilitating broad market access.

Market Constraints:

  • Safety Risks: Overdose can cause hyperkalemia, increasing regulatory pressure for strict dosing and labeling.
  • Price Competition: Several generic manufacturers position at low price points, reducing profit margins.
  • Consolidation of Manufacturers: Major pharma companies dominate distribution, limiting entry of smaller players.

How Is the Market Structured?

The market includes both branded and generic products. The dominant players are generic firms that supply hospital procurement channels.

Segment Market Share (Estimated) Key Manufacturers
Generics 70-80% Pfizer, Mylan, Teva, Hikma, Sandoz
Branded Products 20-30% U.S. based Fresenius Kabi, Baxter

Pricing: The average wholesale price for a 100 ml infusion containing 30 mEq potassium chloride ranges from $5 to $15, varying by supplier and volume discounts.

Distribution Channels: Mainly hospital pharmacies, infusion therapy providers, and clinics.

Financial Trajectory: Revenue and Growth Projections

Past Trends (2017-2022):

  • Global Market Size: Estimated at $600 million in 2022, with a compound annual growth rate (CAGR) of approximately 4% (MarketWatch, 2022).
  • Regional Breakdown: North America accounts for circa 50%, followed by Europe at 30%, Asia-Pacific at 15%, and the rest of the world.

Forecast (2023-2028):

  • Projected Market Size: Expected to reach $750-800 million by 2028.
  • Annual Growth Rate: Estimated CAGR of 3-4%, driven by expanding healthcare infrastructure and aging populations.
  • Major Growth Opportunities: Emerging markets in Asia-Pacific (China, India) anticipate higher CAGR (~6%) due to increased hospital investments.

Revenue Distribution by Customer Type:

Customer Type Percentage of Revenue (approximate)
Hospital Procurement 60%
Outpatient Clinics 20%
Home-care Infusion Providers 10%
Other (research labs, etc.) 10%

Profitability Outlook:

  • Gross margins for manufacturers range between 55-65% due to high-volume generic production.
  • Market competition pressures may lead to slight margin compression over the next five years, especially in highly commoditized segments.

Key Factors Influencing Future Financial Trends

  • Market Consolidation: Increased mergers among generics manufacturers could favor economies of scale but constrain pricing flexibility.
  • Regulatory Environment: Stricter safety and labeling regulations can raise costs but improve product differentiation.
  • Pricing Pressure: Growing prevalence of low-cost imports from emerging markets may depress prices.
  • Innovation and New Formulations: Introduction of pre-mixed, ready-to-use formulations may open new revenue streams but require additional R&D investment.

Summary of Critical Data

Data Point Value/Projection Source
Global market size (2022) $600 million MarketWatch (2022)
Estimated CAGR (2023-2028) 3-4% Industry estimates
Regional market share in 2022 North America 50% Industry reports
Price range for 100 ml infusion $5 - $15 Market surveys
Major players Pfizer, Mylan, Teva, Hikma, Sandoz Industry data
Reimbursement in US Covered under hospital inpatient drugs CMS reimbursement policy

Key Takeaways

  • The market for potassium chloride 30 mEq in plastic containers is mature with steady growth driven by clinical demand.
  • Generic products dominate, with pricing pressures influencing profit margins.
  • Growth prospects are strongest in emerging markets, driven by increased healthcare infrastructure and regulatory approvals.
  • Safety concerns and regulatory compliance influence product formulations and labeling.
  • Innovation in packaging and formulations could create new revenue sources but involve higher R&D costs.

FAQs

Q1: What factors influence pricing for potassium chloride 30 mEq in plastic containers?
Pricing is primarily influenced by manufacturing costs, market competition, procurement volume, and regional reimbursement policies.

Q2: How does regulation impact the market?
Regulatory standards for safety, labeling, and manufacturing practices influence compliance costs and market entry barriers.

Q3: Who are the main competitors?
Major generic manufacturers like Pfizer, Mylan, Teva, Hikma, and Sandoz.

Q4: What are growth opportunities?
Emerging markets, new formulations, and improved delivery systems.

Q5: What risks could affect market stability?
Regulatory changes, safety recalls, price competition, and supply chain disruptions.


References

[1] Sezer, M., et al. (2020). Incidence and clinical significance of hypokalemia in hospitalized patients. Journal of Clinical Medicine, 9(3), 729.

[2] MarketWatch. (2022). Global electrolyte solutions market report. Retrieved from https://www.marketwatch.com

[3] United States Food and Drug Administration (FDA). (2022). Potassium chloride injection monograph. Retrieved from https://www.fda.gov

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