CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER Drug Patent Profile

When do Clinimix E 5/15 Sulfite Free W/ Elect In Dextrose 15% W/ Calcium In Plastic Container patents expire, and what generic alternatives are available?

Clinimix E 5/15 Sulfite Free W/ Elect In Dextrose 15% W/ Calcium In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% 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.

Summary for CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% 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 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER	amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride	INJECTABLE;INJECTION	020678-017	Mar 26, 1997		RX	Yes	Yes

Investment Scenario and Fundamentals Analysis for CLINIMIX E 5/15 Sulfite-Free with Electrolytes in Dextrose 15% with Calcium

Last updated: February 13, 2026

Overview

CLINIMIX E 5/15 is a specialized intravenous (IV) nutritional product formulated with electrolytes, dextrose, and calcium. It is used for parenteral nutrition in clinical settings, particularly where sulfite-free formulations are preferred to reduce risks of allergic reactions or sensitivities.

Market Context and Demand Drivers

• Hospital and Clinical Usage: The global IV nutrition market is expanding due to increased prevalence of malnutrition, cancer, and gastrointestinal disorders. The market is projected CAGR of 6.2% from 2023 to 2030.
• Sulfite-Free Trend: Growing awareness of sulfite sensitivities and allergies pushes demand for sulfite-free formulations, representing a niche but expanding segment.
• Regional Variance: North America and Europe lead in adoption, owing to higher healthcare standards and regulatory support. Emerging markets are projected to grow significantly due to expanding healthcare infrastructure.

Regulatory Environment

• FDA & EMA: Both agencies approve sterile, ready-to-use IV nutritional products with stringent requirements. Sulfite-free formulations must meet specific traceability and safety standards.
• Labeling & Patents: Existing patents for IV nutrition formulations may affect market entry and licensing strategies. It is essential to verify patent expiration dates and exclusivity periods for similar formulations.

Product Fundamentals

Attribute	Details
Formulation	Electrolytes, dextrose (15%), calcium, sulfite-free
Packaging	Plastic container (PE or PVC)
Stability	24-48 hours post-preparation, confirmed with stability studies
Storage	Refrigerator, 2-8°C, protect from light

• Active Ingredients:
  • Dextrose 15% (w/v): Provides calories and hydration
  • Calcium (specific concentration pending): Critical for bone health and metabolic function
  • Electrolytes: Maintain osmotic balance and cardiac function
• Sulfite-Free Status: Eliminates potential for allergic reactions, increasing safety profile.

Competitive Landscape

• Major Suppliers: Baxter, Fresenius Kabi, B. Braun, and locally approved generics.
• Differentiators: Sulfite-free formulation, calcium content, packaging, and shelf life.
• Pricing Dynamics: Premium pricing for specialty formulations; price range typically $5–$20 per 100 mL based on region and volume.

R&D and Manufacturing Considerations

• Manufacturing Standards: Compliance with USP, EP, or JP pharmacopeias.
• Cost Structure:
  • Raw materials: Dextrose, electrolytes, calcium salts, plastics
  • Quality control: Rigorous sterility and stability testing
  • Regulatory compliance costs: Certification, validation, and audits

Potential R&D investments include stability enhancement, extended shelf life, or novel electrolyte combinations. Manufacturing scale-up hinges on reliable supply chains for raw materials, especially calcium salts and electrolytes.

Investment Risks

• Regulatory Delays: Approval processes may extend time-to-market.
• Market Penetration: Limited by existing entrenched competitors and hospital purchasing protocols.
• Patent Landscape: Potential patent restrictions on specific formulations or delivery systems.

Financial Outlook

• Revenue Potential: Moderate, constrained by hospital procurement cycles and formulary approvals.
• Margins: Approximately 20–30%, given premium positioning and manufacturing costs.
• Investment Horizon: 3–5 years to achieve significant market penetration, with a focus on establishing contracts with hospital systems.

Key Takeaways

• The product fits into a growing niche emphasizing sulfite-free IV nutrition.
• Market expansion is driven by clinical necessity and safety trends.
• Regulatory compliance and production quality are critical.
• Competition is established but leaves room for specialty or enhanced formulations.
• Cost and regulatory barriers require strategic planning.

FAQs

1. What is the primary clinical advantage of sulfite-free formulations?
   They reduce allergic reaction risks, making them suitable for sensitive patient populations.

2. What are typical entry barriers for new suppliers?
   Regulatory approval, establishing manufacturing standards, and securing hospital formularies.

3. Are there patent constraints on sulfite-free IV formulations?
   Existing patents may cover specific electrolyte compositions; due diligence on patent status is essential.

4. What are the critical quality attributes for CLINIMIX E 5/15?
   Sterility, stability, accurate electrolyte/calcium concentrations, and compatibility with plastics.

5. What market segments are most promising?
   Acute care hospital nutrition departments, oncology centers, and neonatal units.

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Sources
[1] MarketResearch.com, "Intravenous Nutrition Market," 2023.
[2] U.S. Food and Drug Administration, "Guidelines for Parenteral Nutrition," 2022.
[3] Industry reports, "Sulfite-Free Medical Formulations," 2022.