You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 27, 2026

BALANCED SALT Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Balanced Salt, and when can generic versions of Balanced Salt launch?

Balanced Salt is a drug marketed by B Braun and Epic Pharma Llc and is included in two NDAs.

The generic ingredient in BALANCED SALT is calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate. There are two hundred and eighty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for BALANCED SALT?
  • What are the global sales for BALANCED SALT?
  • What is Average Wholesale Price for BALANCED SALT?
Drug patent expirations by year for BALANCED SALT
Drug Prices for BALANCED SALT

See drug prices for BALANCED SALT

Recent Clinical Trials for BALANCED SALT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Lowy Medical Research Institute LimitedPHASE3
rebro University, SwedenPHASE4
Hospices Civils de LyonPHASE2

See all BALANCED SALT clinical trials

US Patents and Regulatory Information for BALANCED SALT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
B Braun BALANCED SALT calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate SOLUTION;IRRIGATION 091387-001 Feb 3, 2010 AT RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Epic Pharma Llc BALANCED SALT calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate SOLUTION;IRRIGATION 075503-001 Sep 27, 2006 DISCN No 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

BALANCED SALT Market Analysis and Financial Projection

Last updated: February 4, 2026

What Are the Market Dynamics for BALANCED SALT?

Overview:
BALANCED SALT is a generic or branded pharmaceutical compound used primarily in electrolyte solutions, intravenous therapies, or nutritional supplements. Market acceptance hinges on several factors, including clinical efficacy, manufacturing costs, competition from existing electrolytes, and regulatory considerations.

Market Drivers

  • Increase in chronic disease prevalence: Chronic kidney disease, heart failure, and dehydration cases rise globally. The demand for electrolyte management solutions, including BALANCED SALT, grows correspondingly.
  • Growth in outpatient and home healthcare: The shift toward outpatient treatments and home infusion reduces dependence on hospitalization, boosting demand for electrolyte formulations.
  • Regulatory support for electrolyte supplements: Agencies such as the FDA streamline registration for established electrolyte-based interventions, aiding new product entry.

Market Challenges

  • High competition: Numerous electrolytes exist, such as sodium chloride, saline solutions, and other balanced salt compositions.
  • Pricing pressures: Intense generic competition and price erosion limit revenue potential.
  • Regulatory hurdles: Approval requires demonstrating safety, efficacy, manufacturing quality, and compliance with Good Manufacturing Practices.

Geographical Dynamics

  • North America: Largest market; driven by high healthcare expenditure and chronic disease burden.
  • Europe: Second largest; regulatory frameworks are similar to the US but with slower approval processes.
  • Asia-Pacific: Rapid growth due to increasing healthcare infrastructure, rising chronic illness, and expanding pharmaceutical manufacturing capacity.

Market Size and Forecast

Year Global Electrolyte Solutions Market (USD billion) CAGR (2018-2023) Projected Market Size (2028)
2023 $2.8 7% $4.75

Source: Grand View Research, 2023

BALANCED SALT Specific Market:
No precise figures available for BALANCED SALT standalone; market estimations focus on electrolyte solutions, with generic salts capturing significant share. The product's incremental value depends on formulation advantages and patent status.

What Is the Financial Trajectory for BALANCED SALT?

Revenue Potential

In mature markets, pricing for electrolyte solutions typically ranges from $0.10 to $0.50 per gram, depending on formulation and brand. The expected revenue trajectory at scale depends on adoption rates, pricing strategies, and regulatory approvals.

Cost Structure

  • Manufacturing: Bulk sodium chloride and potassium salt are low cost (~$0.05–$0.10 per gram). Purification, quality control, and formulation add costs.
  • Regulatory approvals: Filing fees, clinical trials, and compliance costs vary by region; US FDA labeling and approval can cost between $1–$5 million.
  • Distribution & marketing: Established channels diminish marginal costs after initial investment.

Profit Margins

Margins fluctuate based on competition and patent exclusivity. Generic salts in electrolyte formulations tend to operate with thin margins (~10–15%). Branded or improved formulations can command higher margins (~20–30%).

Investment Considerations

  • Product differentiation: Incorporating proprietary formulations could increase market share.
  • Partnerships: Collaborations with hospitals, infusion centers, and pharmaceutical companies facilitate faster market entry.
  • Scaling production: Economies of scale reduce costs, improving margins.

Revenue Growth Projection (Assumption-Based)

Year Estimated Revenue (USD millions) Assumptions
2023 $10 Entry-level in select markets
2025 $25 Expanded distribution, increased clinical use
2028 $50 Widespread adoption, new formulations

Risks

  • Market saturation by existing salts or solutions
  • Regulatory delays delaying market entry
  • Price competition driving margins down

Summary

BALANCED SALT occupies a segment with steady demand aligned with electrolyte solution markets. Growth depends on regulatory approval, manufacturing efficiency, and market penetration. The financial trajectory projects modest growth in the short term, with potential acceleration through product differentiation and regional expansion.

Key Takeaways

  • Market opportunities align with growth in electrolyte solutions driven by increasing chronic disease and outpatient care.
  • Competition from established salts and pricing pressures constrict potential margins.
  • Global market size for electrolyte solutions is projected to grow at a CAGR of 7%, reaching $4.75 billion by 2028.
  • Revenue potential depends on formulation, scale, and market access, with margins improving through differentiation.
  • Regulatory pathways vary by region, impacting time-to-market and cost structure.

FAQs

1. What factors influence the market share for BALANCED SALT?
Market share depends on regulatory approval, clinical acceptance, production costs, distribution channels, and competitive positioning.

2. How does competition from existing electrolyte solutions affect profitability?
Intense competition leads to price erosion and thin margins. Product differentiation can mitigate these effects.

3. What are the key regulatory hurdles for BALANCED SALT?
Approval requires demonstrating safety and efficacy, complying with GMP standards, and satisfying regional regulatory agencies like FDA and EMA.

4. What is the outlook for growth in the Asia-Pacific region?
This region exhibits rapid growth due to expanding healthcare infrastructure and rising chronic disease rates, making it a promising market.

5. How can manufacturing costs be optimized?
By scaling production, securing supplier agreements for raw materials, and streamlining quality controls.


References

  1. Grand View Research, "Electrolyte Solutions Market Analysis," 2023.
  2. US Food and Drug Administration, "Guidance for Industry," 2022.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.