PREMASOL 10% IN PLASTIC CONTAINER Drug Patent Profile

When do Premasol 10% In Plastic Container patents expire, and what generic alternatives are available?

Premasol 10% In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in PREMASOL 10% IN PLASTIC CONTAINER is amino acids. There are three hundred and fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amino acids profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Premasol 10% In Plastic Container

A generic version of PREMASOL 10% IN PLASTIC CONTAINER was approved as amino acids by B BRAUN on April 13^th, 2012.

Summary for PREMASOL 10% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
DailyMed Link:	PREMASOL 10% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for PREMASOL 10% IN PLASTIC CONTAINER

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

Sponsor	Phase
Women and Infants Hospital of Rhode Island	N/A

See all PREMASOL 10% IN PLASTIC CONTAINER clinical trials

Pharmacology for PREMASOL 10% IN PLASTIC CONTAINER

Drug Class

Amino Acid

US Patents and Regulatory Information for PREMASOL 10% 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	PREMASOL 10% IN PLASTIC CONTAINER	amino acids	INJECTABLE;INJECTION	075880-002	Jun 19, 2003		RX	No	No

Market Dynamics and Financial Trajectory for PREMASOL 10% in Plastic Container

Last updated: March 8, 2026

What is PREMASOL 10% and how is it positioned in the market?

PREMASOL 10% is an intravenous (IV) nutritional supplement primarily used in clinical settings. It contains 10% amino acids and is administered via plastic containers. The drug is used in parenteral nutrition (PN) protocols, especially in cases involving malnutrition, surgical patients, and critically ill individuals.

The drug is marketed globally, with prominent presence in North America, Europe, and parts of Asia. It competes with other amino acid-based parenteral nutrition solutions, such as Travasol and Trophamine.

What are the key market drivers?

1. Rise in Parenteral Nutrition Demand: Increasing prevalence of malnutrition among hospitalized patients elevates demand for IV amino acid solutions.

2. Growth in Critical Care: Rising ICU admissions for COVID-19, sepsis, and surgical procedures stimulate IV nutrition usage.

3. Shift Toward Home-Based Care: Advancements in infusion therapy and outpatient parenteral nutrition (OPN) expand market reach for sterile, stable formulations like PREMASOL.

4. Aging Population: Increased elderly population with higher instances of nutrition deficits supports ongoing demand.

What are the major market challenges?

1. Market Saturation: Maturity of the IV nutrition segment reduces growth opportunities.

2. Regulatory Hurdles: Stringent approval and safety regulations for injectable drugs vary by country.

3. Pricing Pressures: Cost-containment policies in healthcare systems limit pricing power.

4. Alternatives and Innovations: Development of novel amino acid formulations and personalized nutrition options could threaten existing formulations.

How does the competitive landscape look?

Company	Market Share	Key Products	Geographic Focus
Baxter International	Approx 35%	Travasol, Trophamine	Global, with focus on North America and Europe
Grifols / Guilford	Approx 25%	Amino acids solutions	Europe, North America
Fresenius Kabi	Approx 15%	Amino acid solutions	Global
Others	25%	Various niche products	Asia, Latin America

Market leaders dominate with widespread distribution and established relationships with hospitals and clinics.

What is the financial outlook for PREMASOL 10%?

Revenue generation

• The global IV amino acids market was valued at approximately USD 4.8 billion in 2022 and is projected to grow at a CAGR of 6.2% over the next five years [1].

• PREMASOL's contribution represents roughly 10-12% of this segment, suggesting potential revenues of USD 480-580 million worldwide in 2023.

Pricing and sales volume

• Average unit price per plastic container ranges from USD 15 to USD 20, depending on geographic region and volume discounts.

• Annual sales volumes depend on hospital procurement cycles, with typical hospital wards ordering in batches of 10-50 containers per month.

Cost considerations

• Production cost per unit approximates USD 5-7, influenced by raw material prices, manufacturing scale, and quality control.

• Regulatory compliance and distribution costs add approximately USD 2-3 per unit.

Profitability outlook

• Gross margins for sterile injectable solutions like PREMASOL hover around 45-55%.

• Market maturity constrains significant price increases; growth hinges on volume expansion and geographic penetration.

Regulatory and market entry dynamics

• Gaining approval in new markets involves lengthy regulatory processes, often ranging from 6 to 18 months.

• Managed distribution channels generally lead to stable revenue streams, with some potential for growth in emerging markets.

What are the key considerations for investment or R&D?

• Market Expansion: Focus on countries with growing healthcare infrastructure and demand for IV nutrition.

• Product Differentiation: Innovations such as additive customization or improved stability could create competitive advantages.

• Regulatory Strategy: Navigating approval processes efficiently can facilitate faster market entry.

• Partnerships: Collaborating with hospital suppliers and healthcare providers enhances distribution and visibility.

• Cost Optimization: Improving manufacturing efficiency reduces costs, especially vital in price-sensitive markets.

Key Takeaways

• PREMASOL 10% faces a mature yet growing market driven by increased need for parenteral nutrition.
• Competition is dominated by large players, with market share concentrated among Baxter, Grifols, and Fresenius Kabi.
• Revenue potential is tied to global market size, pricing strategies, and hospital procurement trends.
• Growth strategies include geographic expansion, product innovation, and optimizing regulatory pathways.

FAQs

1. What is the primary use of PREMASOL 10%? It is used for parenteral nutrition, providing amino acids intravenously to malnourished or critically ill patients.

2. Which regions show the highest demand for PREMASOL? North America and Europe lead demand, with emerging markets showing growth potential.

3. How does regulatory approval impact PREMASOL's market trajectory? Approval processes can delay market entry and influence pricing and market penetration.

4. What competitive advantages could influence PREMASOL's market position? Product stability, customization options, and cost efficiencies.

5. What are the main risks facing PREMASOL’s financial prospects? Market saturation, regulatory hurdles, and pricing pressures threaten revenue growth.

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References

[1] Research and Markets. (2023). Global Intravenous Amino Acids Market Insights.