GLYCINE 1.5% IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Glycine 1.5% In Plastic Container, and what generic alternatives are available?

Glycine 1.5% In Plastic Container is a drug marketed by B Braun, Baxter Hlthcare, Hospira, and Otsuka Icu Medcl. and is included in four NDAs.

The generic ingredient in GLYCINE 1.5% IN PLASTIC CONTAINER is glycine. There are thirty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the glycine profile page.

Summary for GLYCINE 1.5% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	4
NDAs:	4

US Patents and Regulatory Information for GLYCINE 1.5% 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
B Braun	GLYCINE 1.5% IN PLASTIC CONTAINER	glycine	SOLUTION;IRRIGATION	016784-001	Approved Prior to Jan 1, 1982	AT	RX	No	No
Otsuka Icu Medcl	GLYCINE 1.5% IN PLASTIC CONTAINER	glycine	SOLUTION;IRRIGATION	018315-001	Approved Prior to Jan 1, 1982	AT	RX	No	No
Baxter Hlthcare	GLYCINE 1.5% IN PLASTIC CONTAINER	glycine	SOLUTION;IRRIGATION	018522-001	Feb 19, 1982		DISCN	No	No
Hospira	GLYCINE 1.5% IN PLASTIC CONTAINER	glycine	SOLUTION;IRRIGATION	017633-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Investment Scenario and Fundamentals Analysis for Glycine 1.5% in Plastic Container

Last updated: April 16, 2026

What is the current market for Glycine 1.5% in Plastic Containers?

Glycine 1.5% solutions are used primarily as intravenous (IV) infusions, playing roles in electrolyte balance, neurological applications, and as a supplement in parenteral nutrition. The global infusion therapy market was valued at USD 25.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7.2% through 2030.[1] The segment for amino acid solutions, including glycine, accounts for approximately 15% of this market, with demand driven by increasing hospitalizations, aging populations, and rising chronic disease prevalence.

What are the key investment considerations?

Market Size and Growth

• Estimated global demand for glycine solutions in medical use exceeds 500 metric tons annually, with growth driven by increased IV therapy adoption.
• The primary regions of consumption are North America (35%), Europe (25%), and Asia-Pacific (30%), with expansion in emerging markets.

Competitive Landscape

• Major players include Pfizer, Baxter, Fresenius Kabi, and local manufacturers in emerging markets.
• Production capacity for glycine-based IV solutions varies, with top suppliers capable of producing 10–50 million units annually.
• Market entry requires regulatory approvals (FDA, EMA, CFDA), manufacturing compliance (GMP), and established distribution channels.

Manufacturing and Supply Chain

• Glycine injection solutions are formulated in sterile, pyrogen-free environments.
• Raw materials include glycine powder, sterilization services, and plastic containers compliant with regulations.
• Storage stability is over 24 months at controlled room temperatures, minimizing logistics risks.

Regulatory and Patent Environment

• No patents currently block production of glycine 1.5% formulations, but specific packaging and delivery systems may carry IP restrictions.
• Harmonized regulatory pathways exist in major regions, requiring submission of stability, safety, and efficacy data.

Cost Structure and Pricing

• Manufacturing costs per unit are approximately USD 0.05–0.10, including raw materials, labor, and sterilization.
• Selling prices range from USD 0.50 to 2.00 per unit, influenced by dosage, packaging size, and regional regulations.
• Profit margins are typically 40–60%, with higher margins in emerging markets.

What are the fundamental risks?

Regulatory Risks

• Delays or denials in approvals can impede time-to-market.
• Post-market surveillance may lead to additional documentation requirements.

Market Risks

• Increased competition or pricing pressures can erode margins.
• Changes in clinical practice guidelines can affect demand.

Supply Chain Risks

• Disruption of raw material supply or sterilization capacity can impact production.
• Logistics and storage costs may rise due to regional instability.

Technology Risks

• Advances in alternative therapies or formulations could reduce demand.
• Innovation in drug delivery systems might shift preferences away from plastic containers.

Investment Outlook

Businesses looking into manufacturing or distributing Glycine 1.5% solutions should evaluate:

• Access to GMP-certified production facilities.
• Establishment of regulatory approval pathways.
• Development of distribution networks in targeted regions.
• Cost optimization strategies to remain competitive.

Investors may consider early-stage companies with low-cost production capabilities and regional penetration plans as high-growth opportunities. Conversely, established pharmaceutical firms with existing infrastructure present lower risk but potentially less upside.

Key Takeaways

• The glycine IV solution market is expanding, driven by increasing healthcare needs.
• Entry requires significant regulatory compliance and supply chain stability.
• Production costs are low relative to retail pricing, offering healthy margins.
• Competition and regulatory risks necessitate thorough planning.
• Market growth prospects remain favorable with regional and demographic expansion.

FAQs

1. What are the primary medical uses of Glycine 1.5% solutions?
   They are mainly used for electrolyte replenishment, neurological support, and in parenteral nutrition.

2. What are the main regulatory considerations?
   Manufacturers need approval from regional agencies such as the FDA or EMA with data on safety, stability, and efficacy.

3. What is the typical production cost per unit?
   USD 0.05–0.10 per unit, depending on scale and location.

4. How competitive is the market?
   Market is moderately competitive with established multinational players and regional manufacturers.

5. What are key growth drivers?
   Increased hospitalizations, aging populations, and rising use of IV therapies.

References

[1] Grand View Research. (2023). Infusion Therapy Market Size, Share & Trends Analysis Report.