Last Updated: May 10, 2026

CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Clinimix E 2.75/10 Sulfite Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container, and what generic alternatives are available?

Clinimix E 2.75/10 Sulfite Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER is amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride. There are three hundred and fifty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride profile page.

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Summary for CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER

US Patents and Regulatory Information for CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM 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 CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride INJECTABLE;INJECTION 020678-002 Mar 26, 1997 RX Yes Yes ⤷  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 of CLINIMIX E 2.75/10 Sulfite-Free with Electrolytes in Dextrose 10% with Calcium (Plastic Container)

Last updated: March 2, 2026

What is the current market position of CLINIMIX E 2.75/10?

CLINIMIX E 2.75/10 is a parenteral nutrition (PN) formulation used in hospitals for intravenous feeding. Its key features include being sulfite-free, containing electrolytes, dextrose at 10%, and calcium, supplied in a plastic container. Its target markets include hospitals, clinics, and long-term care facilities that require stable, customizable PN solutions.

Market share estimates place this product within the global parenteral nutrition segment, which was valued at approximately $2.8 billion in 2021, projected to grow at a CAGR of 7.1% from 2022 to 2028. Major players include Baxter International, Fresenius Kabi, hospital-specific compounding facilities, and niche nutraceutical manufacturers.

What are the growth drivers and challenges?

Drivers:

  • Increase in disease burden: Rising cases of malnutrition, gastrointestinal disorders, and cancer lead to higher demand for total parenteral nutrition (TPN) solutions.
  • Hospitalization rates: Increased hospitalization and intensive care admissions, especially during the COVID-19 pandemic, have driven demand.
  • Product safety features: Sulfite-free formulations reduce allergic reactions, enhancing safety profiles, appealing to hospitals' quality standards.
  • Customization needs: The ability to tailor electrolyte and glucose concentrations sustains demand for specific formulations like CLINIMIX E 2.75/10.

Challenges:

  • Pricing pressures: Hospitals and healthcare systems seek cost-effective alternatives, compress margins.
  • Regulatory hurdles: Variability in approval processes across jurisdictions affects rapid market penetration.
  • Manufacturing constraints: Ensuring sterile, preservative-free, and stable solutions in plastic containers demands high-quality manufacturing infrastructure.
  • Competition: Established players hold significant market share with brand recognition and extensive distribution networks.

What is the financial trajectory outlook?

Revenue estimates:

Based on market trends, in 2022, global TPN product sales, including formulations similar to CLINIMIX E 2.75/10, approached $350 million. Assuming a conservative market share of 2% for a niche product targeting institutional clients, annual revenues could approximate $7 million.

Growth considerations:

  • With a CAGR of approximately 6-8% in the TPN segment, revenues could reach between $9 million and $12 million by 2026, assuming steady adoption.
  • Institutional contracts favor long-term revenue stability, but market share gains depend on competitive positioning, regulatory approvals, and clinical utility.

Cost structure:

  • Manufacturing costs primarily include raw materials (dextrose, electrolytes, calcium), container production, sterilization, and quality assurance.
  • Margins are influenced by procurement costs, pricing strategies, and sales volume.
  • Average gross margins in this sector range from 25% to 35%.

What are the competitive and regulatory factors?

  • Competitive landscape: Major manufacturers offer multi-solution portfolios, with some focusing on specialty formulations, impacting the niche positioning of CLINIMIX E 2.75/10.
  • Regulatory environment: Approvals from bodies such as FDA, EMA, and country-specific agencies determine market access timelines and labeling claims.
  • Pricing policies: Reimbursement and procurement policies differ globally, affecting revenue potential.

What is the market entry strategy?

  • Leverage existing regulatory approvals in key markets.
  • Establish collaborations with hospital groups and distribution networks.
  • Emphasize safety features, such as sulfite-free formulation, to differentiate.
  • Invest in clinical data demonstrating efficacy and safety to support formulary inclusion.

How does the product compare to alternatives?

Feature CLINIMIX E 2.75/10 Competitors
Sulfite-free Yes Varies
Electrolyte composition Customizable, includes calcium Similar or fixed formulations
Container type Plastic, sterile Glass optional, sterile
Dextrose concentration 10% 10–20% depending on formulation
Safety profile High, due to sulfite removal Similar, with varying preservative content

Key Takeaways

  • The product operates within a growing TPN market driven by increased hospitalization and disease burden.
  • Revenue projections suggest modest growth, contingent on successful market expansion and regulatory clearance.
  • Competition is intense, with major pharmaceutical companies holding significant market share.
  • Cost and pricing strategies significantly influence profitability.
  • Differentiators like sulfite-free formulation and customization potential can enhance market positioning.

FAQs

  1. What regulatory hurdles does CLINIMIX E 2.75/10 face in international markets?
    It must meet the approval requirements of each jurisdiction, including stability data, labeling standards, and manufacturing quality certifications.

  2. How does the sulfite-free feature impact safety and marketability?
    Removing sulfites reduces allergic reaction risk, making the product suitable for sensitive patients and aligning with safety-focused hospital protocols.

  3. What are the main competitive advantages of CLINIMIX E 2.75/10?
    Its sulfite-free composition, electrolyte profile including calcium, and compatibility with existing hospital infusion systems.

  4. What are potential barriers to expanding market share?
    Established competitors with broader product lines, price sensitivities, and regulatory delays.

  5. What strategies could boost revenue growth?
    Securing institutional supply contracts, expanding into emerging markets, and investing in clinical evidence to support formulary approvals.


References

[1] MarketsandMarkets. (2022). Total Parenteral Nutrition Market Report.
[2] Grand View Research. (2021). Parenteral Nutrition Market Size, Share & Trends.
[3] U.S. Food and Drug Administration. (2022). Guidance for Industry: Parenteral Nutritional Products.
[4] European Medicines Agency. (2022). Summary of Product Characteristics.
[5] Company filings and product labels (published data).

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