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Last Updated: December 28, 2025

GLYCINE 1.5% IN PLASTIC CONTAINER Drug Patent Profile


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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.

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Summary for GLYCINE 1.5% IN PLASTIC CONTAINER
Drug patent expirations by year for GLYCINE 1.5% IN PLASTIC CONTAINER
Recent Clinical Trials for GLYCINE 1.5% IN PLASTIC CONTAINER

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SponsorPhase
Janssen Research & Development, LLCPHASE1
Vanderbilt University Medical CenterPhase 4
National Institute on Aging (NIA)Phase 4

See all GLYCINE 1.5% IN PLASTIC CONTAINER clinical trials

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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Otsuka Icu Medcl GLYCINE 1.5% IN PLASTIC CONTAINER glycine SOLUTION;IRRIGATION 018315-001 Approved Prior to Jan 1, 1982 AT RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare GLYCINE 1.5% IN PLASTIC CONTAINER glycine SOLUTION;IRRIGATION 018522-001 Feb 19, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira GLYCINE 1.5% IN PLASTIC CONTAINER glycine SOLUTION;IRRIGATION 017633-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 for Glycine 1.5% in Plastic Container

Last updated: July 29, 2025

Introduction

Glycine, an amino acid commonly used in clinical and industrial applications, has garnered increased attention within pharmaceutical formulations. The formulation of Glycine 1.5% in a plastic container represents a specific product niche, mainly used in specialized medical and research settings. This article examines the evolving market dynamics and financial trajectory of this product, considering manufacturing trends, regulatory factors, competitive landscape, and emerging opportunities.

Market Overview

The pharmaceutical sector’s demand for amino acids like glycine continues to expand owing to their therapeutic, nutritional, and industrial utility. Glycine 1.5%, typically utilized as an excipient or supplemental agent, finds application in biopharmaceuticals, nutritional formulas, and laboratory solutions [1].

The traditional delivery formats favor glass vials; however, plastic containers, especially PET (Polyethylene Terephthalate) or alternative polymers, are increasingly adopted owing to advances in material safety, convenience, and logistical efficiencies [2]. The shift favors products like Glycine 1.5% in plastic, which benefits from lower weight, breakage resistance, and scalability.

Market Drivers

1. Growing Pharmaceutical and Biotech Industries

The global pharmaceutical market is projected to reach $1.6 trillion by 2025, with Asia-Pacific, North America, and Europe leading growth trajectories [3]. The increasing demand for amino acids in therapeutic formulations and bioprocessing directly amplifies the need for glycine-based solutions.

2. Increased Adoption of Ready-to-Use Formulations

Operators favor sterile, ready-to-use solutions that reduce preparation errors and enhance patient safety. Plastic containers facilitate such formulations, aligning with industry trends toward pre-filled and single-use packaging.

3. Advances in Container Technologies

Modern plastics offer high barrier properties, chemical resistance, and compliance with regulatory standards (such as USP, EP, and FDA guidelines). These innovations improve product stability and safety, boosting market trust [4].

4. Regulatory Environment

Global policies emphasizing safe handling, waste reduction, and eco-friendly packaging sway manufacturers toward adopting plastic solutions. Regulatory approvals for plastic containers in parenteral and injectable formulations have expanded, reducing market entry barriers [5].

5. Emerging Markets and Payor Trends

Emerging economies increasingly adopt innovative pharmaceutical packaging, driven by rising healthcare expenditure and infrastructure improvements. Plastic containers' cost-effectiveness and logistical benefits appeal to both manufacturers and healthcare providers in these regions.

Challenges and Limitations

1. Regulatory and Safety Concerns

Potential leachables and extractables from plastic containers pose safety concerns, necessitating stringent quality control and validation processes. Regulatory agencies scrutinize plastic packaging materials, influencing market entry and expansion.

2. Competition with Glass and Alternative Materials

Glass remains a gold standard for certain injectable formulations, owing to its inertness. Plastic adoption faces resistance in applications demanding absolute chemical inertness or long-term storage stability.

3. Environmental Impact and Sustainability

The environmental footprint of plastics, especially single-use containers, incurs regulatory and societal scrutiny. Innovations in biodegradable or recyclable plastics are critical to address this issue and sustain market growth.

Market Segmentation and Geographic Outlook

By Application

  • Clinical & Pharmaceutical Use: Pharmaceuticals requiring amino acids for injection, infusion, or parenteral formulations.
  • Research & Laboratory Use: Reagents for analytical and biotechnological research.
  • Nutritional Supplements: Less common but potential entry point for amino acid modifications.

By Region

  • North America & Europe: Mature markets with high adoption driven by stringent regulations and advanced manufacturing standards.
  • Asia-Pacific: Fastest growth, supported by expanding healthcare infrastructure, increasing R&D activity, and cost-efficient manufacturing.

Financial Trajectory and Investment Outlook

Market Size and Revenue Projections

While specific sales data for Glycine 1.5% in plastic containers are scarce, the broader amino acid and pharmaceutical packaging market is projected to grow at a CAGR of approximately 6-8% through 2025 [6]. Companies involved in manufacturing these formulations are positioned to capitalize on this growth, bolstering revenues through capacity expansion, innovation, and strategic mergers.

Pricing Dynamics

Pricing strategies depend on raw material costs, regulatory compliance expenses, and competitive positioning. The trend towards standardized, high-volume production in APAC facilitates lower unit costs, enabling competitive pricing for global markets.

Investment Opportunities

Investors should monitor advancements in plastic bio-compatible materials, regulatory reforms, and supply chain innovations. Companies integrating sustainable packaging solutions could gain competitive advantage and market share.

Future Trends and Innovation Opportunities

  • Sustainable Packaging: Adoption of biodegradable plastics and recyclable materials.
  • Smart Packaging: Incorporating sensors for temperature, stability, and compliance monitoring.
  • Enhanced Formulation Stability: Advanced polymers offering superior barrier properties to extend shelf life.
  • Customized Containers: Tailored sizes and designs to meet niche clinical needs.

Conclusion

The market for Glycine 1.5% in plastic containers is poised for steady growth, driven by advancements in pharmaceutical manufacturing, regulatory acceptance, and logistical advantages of plastic packaging. Continuous innovation, environmental sustainability, and regulatory navigation will be central to capturing value streams and expanding market share.

Key Takeaways

  • The global demand for amino acid formulations, particularly glycine, is expanding across pharmaceutical and research sectors.
  • The shift from glass to plastic containers is supported by technological, regulatory, and logistical benefits, making plastic bottles an attractive packaging choice.
  • Market growth is driven by emerging economies, innovation in container technology, and the pharmaceutical industry's push for ready-to-use solutions.
  • Challenges include regulatory hurdles related to plastics safety, environmental concerns, and competition from traditional glass packaging.
  • Strategic investment in sustainable packaging materials and smart container solutions present lucrative opportunities.

FAQs

1. What regulatory considerations impact the adoption of Glycine 1.5% in plastic containers?
Regulatory agencies such as the FDA and EMA require comprehensive safety data on leachables, extractables, and plastic compatibility. Validation of container integrity, sterilization, and stability profiles is essential for market approval.

2. How does the shift to plastic containers impact the stability and shelf life of Glycine formulations?
Modern plastics with high barrier properties and inert coatings can maintain formulation stability, ensuring comparable shelf lives to glass. However, rigorous testing is necessary to confirm long-term stability under specified storage conditions.

3. Are there environmental concerns associated with plastic containers for pharmaceuticals?
Yes. Single-use plastics contribute to environmental pollution. The industry is investing in biodegradable plastics and recycling initiatives to mitigate ecological impact and meet sustainability standards.

4. Which regions show the highest growth potential for Glycine in plastic containers?
Emerging markets, particularly in Asia-Pacific, present significant growth opportunities due to expanding healthcare infrastructure, cost advantages, and increasing R&D activities.

5. What innovations are expected to influence the future of plastic packaging for pharmaceutical amino acids?
Upcoming innovations include biodegradable and recyclable plastics, smart packaging with sensors, and tailored container designs to improve stability, safety, and environmental compliance.


Sources

[1] U.S. National Library of Medicine, "Glycine Uses and Applications."
[2] Pharma Packaging News, "Advances in Plastic Container Technologies."
[3] Research and Markets, "Global Pharmaceutical Market Forecast."
[4] European Pharmacopoeia, "Plastic Packaging Standards."
[5] FDA Guidance, "Regulatory Requirements for Plastic Containers."
[6] Grand View Research, "Amino Acid Market Size and Trends."

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