Last Updated: August 2, 2026

CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER Drug Patent Profile


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When do Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container patents expire, and what generic alternatives are available?

Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% 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 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% 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 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride INJECTABLE;INJECTION 020678-001 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

Investment Scenario and Fundamentals Analysis for CLINIMIX E 2.75/5 SULFITE-FREE with Electrolytes in Dextrose 5% and Calcium (Plastic Container)

Last updated: February 13, 2026


Market Overview and Demand Drivers

Intravenous (IV) Nutrition Segment:
CLINIMIX E is part of the IV nutrition market, which grew significantly during the COVID-19 pandemic, driven by increased hospitalizations and parenteral nutrition needs. The global IV nutrition market was valued at approximately USD 10 billion in 2022, with a compound annual growth rate (CAGR) of 6.8% projected through 2027 [1].

Product Specifics:

  • Contains electrolytes (potassium chloride at 2.75% and sodium chloride at 5%)
  • Sulfite-free formulation
  • Includes calcium in dextrose 5% solution
  • Packaged in a plastic container

Key Demand Factors:

  • Rising prevalence of malnutrition, chronic illnesses, and post-operative care.
  • Increased hospitalization rates, especially for critical care.
  • Shift toward safer, preservative-free formulations (sulfite-free) due to allergy concerns.
  • Growing preference for ready-to-use, low-maintenance IV solutions.

Competitive Landscape Analysis

Major Players:

  • Baxter International
  • Hospira (Pfizer)
  • Fresenius Kabi
  • B. Braun
  • Local and regional suppliers

Market Differentiators:
CLINIMIX E's sulfite-free formulation appeals to allergy-sensitive populations, aligning with trends toward preservative-free products. Its inclusion of calcium offers an advantage for balanced electrolyte replenishment.

Product Variants and Differentiation:
Compared to competitors, CLINIMIX E offers a specific electrolyte composition (2.75/5) and calcium inclusion in a plastic container, which reduces breakage risk and enhances portability.


Regulatory and Reimbursement Landscape

Regulatory Environment:

  • Approved by FDA, EMA, or other relevant agencies depending on the regional market.
  • Sulfite-free claims require compliance with preservative safety standards.

Reimbursement Dynamics:

  • IV solutions are generally reimbursed under hospital pharmacy budgets or government-funded healthcare schemes.
  • Pricing is influenced by ingredient sourcing, manufacturing costs, and local regulation.

Market Access Barriers:

  • Stringent approval processes in key markets.
  • Price sensitivities in emerging markets.

Financial and Investment Fundamentals

Aspect Data / Notes Implication
Market size (2022) USD 10 billion, with 6.8% CAGR Growing demand supports expansion opportunities.
Production costs Estimated at 15-20% of sales price, influenced by raw materials and manufacturing efficiencies Cost management critical for margins.
Pricing flexibility Premium due to sulfite-free and calcium features, but price competition exists Potential for higher margins if brand position is strong.
Regulatory approval timelines 12-24 months in new markets (depending on jurisdiction) Delays can impact go-to-market plans.
Patent/IP status Existing patents mainly covering formulation and packaging Protects market share, potential licensing or infringement risks.

Risks and Challenges

  • Regulatory Risks: Stringent approval processes may delay market entry.
  • Competitive Pressure: Large players with established distribution channels can exert price pressures.
  • Supply Chain Disruptions: Raw material shortages, especially for electrolytes and calcium, could increase costs.
  • Market Acceptance: Adoption depends on clinician preference and hospital procurement policies.

Growth Opportunities

  • Expansion into emerging markets with growing hospital infrastructure.
  • Development of similar compositions for pediatric or critical care applications.
  • Partnering with hospital networks for bundled solutions and exclusive supply contracts.
  • Formulation innovations with extended shelf life reducing waste and logistics costs.

Conclusion

Investing in CLINIMIX E hinges on its differentiated sulfite-free profile, balanced electrolyte composition, and fit within hospitalized IV nutrition requirements. The growth outlook is favorable, supported by increasing demand for safe, preservative-free products, though competition and regulatory hurdles pose risks. Strategic positioning, manufacturing efficiency, and regulatory navigation are crucial for long-term profitability.


Key Takeaways

  • The global IV nutrition market is expanding, favoring products like CLINIMIX E.
  • Sulfite-free formulations are increasingly preferred due to allergy concerns.
  • Competitive advantages include balanced electrolytes and calcium inclusion.
  • Entry into new markets depends on regulatory approvals, which can take 1-2 years.
  • Cost control and differentiated positioning can enable premium pricing.

FAQs

1. What is the main competitive advantage of CLINIMIX E?
Its sulfite-free formulation and inclusion of calcium in a ready-to-use IV nutrition solution differentiate it from traditional electrolyte mixes.

2. What are the primary risks for investing in this product?
Regulatory approval delays, intense competition, and supply chain disruptions are primary risks.

3. How does the market size influence the investment potential?
A growing market with a CAGR of 6.8% indicates expanding opportunities for differentiation and sales growth.

4. What could impact pricing strategies for CLINIMIX E?
Market competition, manufacturing costs, and reimbursement policies can influence pricing flexibility.

5. What are the key regulatory considerations?
Compliance with preservative-free standards, safety testing, and approval timelines are critical for market entry.


References

[1] MarketsandMarkets. “Parenteral Nutrition Market by Product Type, Ingredient, and Region,” 2022.
[2] IBISWorld. “Intravenous (IV) Therapy & Nutrition Industry Report,” 2022.

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