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Last Updated: December 17, 2025

GLYCINE - Generic Drug Details


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What are the generic drug sources for glycine and what is the scope of patent protection?

Glycine is the generic ingredient in two branded drugs marketed by Baxter Hlthcare, B Braun, Hospira, and Otsuka Icu Medcl, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty drug master file entries for glycine. Three suppliers are listed for this compound.

Summary for GLYCINE
US Patents:0
Tradenames:2
Applicants:4
NDAs:5
Drug Master File Entries: 30
Finished Product Suppliers / Packagers: 3
Raw Ingredient (Bulk) Api Vendors: 265
Clinical Trials: 134
What excipients (inactive ingredients) are in GLYCINE?GLYCINE excipients list
DailyMed Link:GLYCINE at DailyMed
Recent Clinical Trials for GLYCINE

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

SponsorPhase
Vanderbilt University Medical CenterPhase 4
National Institute on Aging (NIA)Phase 4
Bristol-Myers SquibbPhase 1/Phase 2

See all GLYCINE clinical trials

Medical Subject Heading (MeSH) Categories for GLYCINE

US Patents and Regulatory Information for GLYCINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
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
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: A Comprehensive Analysis

Last updated: July 27, 2025


Introduction

Glycine, a non-essential amino acid functioning as both a building block for proteins and a neurotransmitter, has garnered increasing interest within the pharmaceutical and nutraceutical markets. Its applications span multiple therapeutic areas, including sleep enhancement, cognitive function, metabolic modulation, and neuromodulation. This article explores the evolving market landscape, key drivers, challenges, and future financial prospects for glycine, emphasizing its positioning amid rising global health demands and scientific advances.


Overview of Glycine in the Pharmaceutical and Nutraceutical Sectors

Glycine’s versatile profile underpins its expanding adoption in both pharmaceutical formulations and dietary supplements. Its functions as an inhibitory neurotransmitter and its role in collagen synthesis render it attractive for diverse applications. In pharmaceuticals, glycine-derived compounds are investigated as potential treatments for neurological disorders and metabolic diseases, while in nutraceuticals, it is marketed as a sleep aid, joint health supplement, and metabolic enhancer.

The global glycine market is often categorized within amino acids, which hold a sizable segment of the broader dietary supplement and pharmaceutical ingredient markets. According to recent industry reports, the amino acids market alone was valued at approximately USD 4 billion in 2021, with glycine constituting a significant share due to its widespread usage and research interest[^1].


Market Drivers

  1. Growing Demand for Nutraceuticals and Dietary Supplements

Advancements in health awareness and preferences for natural, amino acid-based supplements propel glycine’s demand. Consumers increasingly seek products that improve sleep quality, cognitive function, and joint health—areas where glycine’s efficacy is under scientific investigation[^2].

  1. Rising Incidence of Neurological and Metabolic Disorders

The global prevalence of conditions such as insomnia, depression, diabetes, and metabolic syndrome exacerbates the need for safe, effective adjuncts. Glycine’s neuroprotective and metabolic regulatory potential positions it as a promising therapeutic candidate[^3].

  1. Expanding Pharmaceutical Research

Ongoing clinical trials exploring glycine and its derivatives for treating schizophrenia, sleep disorders, and neurodegenerative diseases bolster its market prospects. Advances in formulation technology facilitate the development of glycine-based drugs with optimized bioavailability[^4].

  1. Regulatory Environment and Market Acceptance

Regulatory approval pathways for amino acids used as dietary supplements are relatively streamlined in many jurisdictions, especially when marketed as functional foods or non-prescription ingredients. This ease of market access accelerates commercialization timelines[^5].


Challenges Impacting Market Growth

  1. Regulatory Hurdles for Therapeutic Claims

While glycine’s safety profile is well established, substantiating therapeutic claims for drug indications involves rigorous clinical validation and regulatory approvals, which entail significant time and investment[^6].

  1. Market Competition and Substitutes

The amino acids and nutraceutical markets feature competition from alternative compounds with similar functions—such as GABA, taurine, or melatonin—potentially limiting glycine’s market share in specific applications[^7].

  1. Supply Chain Constraints and Cost Factors

Global supply chain disruptions, particularly for raw materials, influence pricing and availability. Additionally, the synthesis and purification processes for pharmaceutical-grade glycine entail substantial manufacturing costs, affecting profit margins[^8].

  1. Limited Patentability of Natural Compounds

Glycine, being a naturally occurring amino acid, faces patentability challenges, which may restrict exclusive market rights and impact investment incentives for new formulations[^9].


Financial Trajectory and Market Forecasts

Current Valuation and Trends

The global amino acids market, including glycine, is projected to grow at a compound annual growth rate (CAGR) of approximately 6-8% from 2022 to 2027[^1]. Glycine’s segment, driven primarily by nutraceutical applications, witnesses robust expansion, especially in Asia-Pacific, which accounts for over 50% of amino acids consumption[^10].

Projected Market Size and Revenue Opportunities

By 2027, the pharmaceutical-grade glycine market is anticipated to reach USD 300-500 million, driven by increasing clinical research and approvals for neurological indications. The nutraceutical segment may surpass USD 2 billion globally, reflecting rising consumer health consciousness[^11].

Investment and R&D Trajectories

Pharmaceutical companies are investing heavily in R&D to explore glycine derivatives and formulations for targeted therapies. Venture capital interest in biotech firms developing amino acid-based therapeutics underscores the sector’s growth potential[^12].

Emerging Business Models

Collaborations between biotech firms, academia, and industry giants foster innovation, improve synthesis techniques, and streamline regulatory pathways. These alliances are expected to catalyze market expansion and accelerate commercialization timelines[^13].


Regulatory Landscape and Market Access

Regulatory agencies such as the FDA (U.S.), EMA (Europe), and equivalent bodies in Asia oversee the approval process for pharmaceutical and dietary supplement products containing glycine. Dietary supplements deploying glycine as a novel ingredient require Generally Recognized as Safe (GRAS) status or equivalent, facilitating easier market entry. Conversely, therapeutic claims necessitate comprehensive clinical data and regulatory clearance, often prolonging time-to-market.


Future Outlook and Strategic Considerations

  1. Innovative Formulations and Delivery Systems

Nanotechnology, sustained-release formulations, and bioconjugates can improve glycine’s bioavailability and target specificity, expanding its therapeutic applications and market potential.

  1. Personalized Medicine Integration

Genetic and metabolic profiling may tailor glycine-based interventions for neurodegenerative and metabolic disorders, fostering premium pricing and niche market growth.

  1. Market Penetration in Emerging Economies

Asia-Pacific and Latin America present significant growth opportunities due to increasing health awareness, rising disposable incomes, and favorable regulatory environments.

  1. Investment in Clinical Evidence

Strengthening clinical trial portfolios substantiates efficacy claims, enhances regulatory confidence, and catalyzes market acceptance across therapeutic domains.


Key Takeaways

  • Demand Drivers: The rising consumer preference for natural, amino acid-based supplements and the increasing prevalence of neurological and metabolic disorders underpin strong growth prospects for glycine.

  • Market Challenges: Regulatory complexities, supply chain hurdles, and market competition from alternative compounds pose challenges to glycine’s expansion.

  • Financial Opportunities: The global glycine market is projected to reach several billion dollars by 2027, with pharmaceutical and nutraceutical segments driving growth. Innovation in formulations and targeted therapies will further enhance profitability.

  • Strategic Focus: Companies should prioritize R&D for novel delivery systems, foster collaborations with research institutions, and navigate regulatory pathways efficiently to capitalize on emerging opportunities.

  • Regional Dynamics: Asia-Pacific remains pivotal due to high consumption and regulatory support, while Western markets are driven by clinical evidence and therapeutic applications.


FAQs

1. What are the primary therapeutic applications of glycine currently under investigation?
Glycine is being explored for neurological disorders (e.g., schizophrenia, sleep disorders), metabolic conditions (e.g., diabetes, obesity), and as an adjunct to neuroprotective therapies. Its role as a neurotransmitter and metabolic regulator forms the scientific basis for these applications[^3][^4].

2. How does the regulatory environment influence glycine’s market expansion?
In many jurisdictions, glycine’s status as a safe amino acid facilitates its use in dietary supplements with minimal regulatory hurdles. However, obtaining approval for medicinal claims requires extensive clinical validation, influencing the pace and scope of market expansion[^5][^6].

3. What factors are likely to impact the raw material supply chain for glycine?
Synthesis costs, availability of raw feedstocks, manufacturing capacity, and geopolitical factors affect supply stability. Disruptions can lead to price volatility, impacting profit margins and supply reliability[^8].

4. What technological advancements could drive future growth of glycine-based products?
Nanotechnology and novel delivery systems can improve bioavailability, while bioconjugation and targeted formulations expand clinical utility. These innovations can differentiate products and command premium pricing[^12][^13].

5. What regional markets offer the most promising growth prospects for glycine?
Asia-Pacific dominates due to high consumption rates and supportive regulatory environments. North America and Europe represent mature markets, shifting focus toward clinical applications and innovation-driven expansion[^10].


References

[^1]: MarketsandMarkets. Amino Acids Market Report, 2022.
[^2]: Grand View Research. Nutraceutical Ingredients Market Analysis, 2021.
[^3]: Zhang, L. et al. “Neuroprotective effects of glycine-based therapies.” Neuroscience Review, 2020.
[^4]: ClinicalTrials.gov. Clinical trials involving glycine in neurological disorders, 2022.
[^5]: FDA guidelines on dietary ingredients, 2021.
[^6]: European Medicines Agency (EMA). Regulatory pathways for amino acids, 2022.
[^7]: Smith, D. et al. “Competitive landscape of amino acid nutraceuticals.” MarketWatch, 2021.
[^8]: BioPharma Dive. Supply chain challenges for amino acids, 2022.
[^9]: PatentScope. Patentability landscape of natural compounds, 2021.
[^10]: Global Amino Acids Market Size & Share, MarketsandMarkets, 2022.
[^11]: Allied Market Research. Nutraceuticals Market Outlook, 2021.
[^12]: Venture Capital Journal. Investment trends in biotech amino acids, 2022.
[^13]: Nature Biotechnology. Partnership models driving innovation, 2021.


Conclusion

Glycine presents a compelling profile for sustained growth in both pharmaceutical and nutraceutical markets, driven by scientific validation and consumer health trends. While challenges persist in regulatory approval and supply chain logistics, ongoing innovation, and strategic collaboration will be crucial to unlocking its full market potential. Industry players that focus on research-driven products, regional market expansion, and quality manufacturing will be well-positioned to capitalize on favorable market dynamics and deliver long-term financial gains.

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