You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 27, 2026

GLYCINE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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: 135
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
Janssen Research & Development, LLCPHASE1
National Institute on Aging (NIA)Phase 4
Vanderbilt University Medical CenterPhase 4

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
Hospira GLYCINE 1.5% IN PLASTIC CONTAINER glycine SOLUTION;IRRIGATION 017633-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare GLYCINE 1.5% IN PLASTIC CONTAINER glycine SOLUTION;IRRIGATION 018522-001 Feb 19, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER glycine SOLUTION;IRRIGATION 017865-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Otsuka Icu Medcl GLYCINE 1.5% IN PLASTIC CONTAINER glycine SOLUTION;IRRIGATION 018315-001 Approved Prior to Jan 1, 1982 AT RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun GLYCINE 1.5% IN PLASTIC CONTAINER glycine SOLUTION;IRRIGATION 016784-001 Approved Prior to Jan 1, 1982 AT RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Glycine: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Glycine is a non-essential amino acid with a diverse range of applications across pharmaceutical, food, and industrial sectors. Its therapeutic potential is being explored in areas including metabolic disorders, neurological conditions, and as a buffering agent. The market for glycine is characterized by stable demand from established applications and emerging opportunities in novel pharmaceutical uses.

What is Glycine and Its Primary Applications?

Glycine is the simplest amino acid, with the chemical formula NH₂CH₂COOH. It functions as a neurotransmitter in the central nervous system, involved in regulating motor control and sensory processing [1]. Its small size and amphoteric nature make it a versatile compound.

Primary applications for glycine include:

  • Pharmaceuticals:
    • Nutritional Supplement: Used to treat certain metabolic disorders and as a component in parenteral and enteral nutrition.
    • Active Pharmaceutical Ingredient (API) Precursor: Serves as a building block for synthesizing other drugs.
    • Therapeutic Agent: Investigated for conditions such as schizophrenia, stroke recovery, and metabolic syndrome.
    • Buffering Agent: Utilized in drug formulations for pH stability.
  • Food Industry:
    • Sweetener: Possesses a mild sweet taste, used in sugar substitutes and flavor enhancers.
    • Preservative: Aids in extending the shelf life of food products.
    • Nutrient Fortification: Added to various food items.
  • Industrial Applications:
    • Metal Complexation: Used in electroplating and metal surface treatment.
    • Chemical Synthesis: Employed as a reagent in organic chemistry.

What are the Key Therapeutic Areas for Glycine?

The pharmaceutical applications of glycine are expanding, particularly in neurology and metabolic health.

Key therapeutic areas include:

  • Neurological Disorders: Glycine acts as an inhibitory neurotransmitter in the spinal cord and brainstem. It is being studied for its potential in treating:
    • Schizophrenia: Glycine has been shown to improve negative symptoms in some patients when used as an adjunctive therapy [2].
    • Stroke: Its neuroprotective properties are under investigation for reducing damage following ischemic events.
    • Tourette Syndrome: Some studies suggest glycine may help reduce tics [3].
  • Metabolic Disorders: Glycine plays a role in glucose metabolism and insulin sensitivity. Research is exploring its use in managing:
    • Type 2 Diabetes: Glycine supplementation may improve glycemic control and insulin sensitivity [4].
    • Metabolic Syndrome: Its potential to reduce inflammation and improve lipid profiles is being examined.
  • Gastrointestinal Health: Glycine is a component of collagen and is involved in gut barrier function. It is used in formulations for digestive support and is being researched for inflammatory bowel disease.
  • Pain Management: Glycine has shown potential in modulating pain pathways, with ongoing research into its analgesic properties.

What are the Market Trends and Growth Drivers for Glycine?

The global glycine market is projected for steady growth, driven by an increasing demand from its diverse end-use industries.

Market trends and growth drivers include:

  • Growing Pharmaceutical Demand: The expanding research and development into glycine's therapeutic applications, particularly in neuroscience and metabolic diseases, is a significant driver. As clinical trials progress and potential approvals emerge, demand for pharmaceutical-grade glycine is expected to rise.
  • Aging Global Population: An aging demographic contributes to increased prevalence of chronic diseases, including neurological and metabolic disorders, thereby boosting demand for supportive therapies and supplements like glycine.
  • Increasing Awareness of Health and Wellness: Consumer focus on health and preventative care drives demand for dietary supplements and functional foods, where glycine finds application.
  • Food and Beverage Industry Expansion: The use of glycine as a sweetener, flavor enhancer, and preservative in the food and beverage sector, especially in emerging economies, contributes to market growth.
  • Technological Advancements in Production: Improvements in manufacturing processes, including enzymatic synthesis and fermentation, are enhancing production efficiency and purity, making glycine more accessible for various applications.
  • Growing Animal Feed Industry: Glycine is used as a feed additive to improve animal growth and health, a sector experiencing consistent expansion globally.

What are the Key Market Challenges and Restraints?

Despite positive growth projections, the glycine market faces certain challenges.

Key challenges and restraints include:

  • Regulatory Hurdles for Pharmaceutical Applications: The development and approval process for glycine as a therapeutic agent is lengthy and rigorous, requiring extensive clinical trials and adherence to strict regulatory standards from bodies like the FDA and EMA.
  • Price Volatility of Raw Materials: The cost of raw materials used in glycine production, such as chloroacetic acid or ammonia, can fluctuate, impacting profit margins for manufacturers.
  • Competition from Alternative Compounds: In certain applications, glycine may face competition from other amino acids or synthetic compounds that offer similar functionalities, potentially limiting market penetration.
  • Supply Chain Disruptions: Global events, such as pandemics or geopolitical instability, can disrupt supply chains, affecting the availability and cost of glycine.
  • Purity and Quality Control: Maintaining high purity standards, especially for pharmaceutical-grade glycine, is critical and can increase production costs.

What is the Competitive Landscape and Key Players?

The global glycine market is moderately consolidated, with several major chemical and pharmaceutical ingredient manufacturers operating globally.

Key market participants include:

  • Ajinomoto Co., Inc.: A prominent Japanese multinational food and biotechnology corporation with significant glycine production.
  • Evonik Industries AG: A German specialty chemicals company that manufactures and supplies amino acids, including glycine.
  • Shandong Longlive Bio-Technology Co., Ltd.: A Chinese company involved in the production of bio-fermented products, including amino acids.
  • Meihua Holdings Group Co., Ltd.: A Chinese biochemical enterprise that is a significant producer of amino acids.
  • Fuso Chemical Co., Ltd.: A Japanese company specializing in fine chemicals, including glycine.
  • GEO Specialty Chemicals: A US-based producer of specialty chemicals, including amino acids.
  • Jubilant Life Sciences: An integrated global pharmaceutical and life sciences company that produces various APIs and intermediates.

These companies compete on factors such as product quality, price, production capacity, and innovation in application development. Strategic partnerships and mergers and acquisitions are also observed as companies aim to expand their market reach and product portfolios.

What is the Financial Trajectory and Market Size Projections?

The financial trajectory of the glycine market is characterized by consistent growth, driven by its established industrial and food applications, alongside the promising pharmaceutical sector.

  • Market Size: The global glycine market was valued at approximately USD 850 million in 2023.
  • Projected Growth: The market is forecast to grow at a Compound Annual Growth Rate (CAGR) of 4.5% to 5.5% over the next five to seven years. This trajectory is expected to push the market valuation to over USD 1.2 billion by 2030.
  • Segmental Growth: The pharmaceutical segment, while currently smaller than industrial or food applications, is projected to exhibit the highest CAGR, driven by increased R&D and potential drug approvals.
  • Geographic Distribution: Asia-Pacific currently dominates the market due to high production volumes and significant consumption from its large industrial and food sectors. North America and Europe are key markets for pharmaceutical-grade glycine and are expected to see steady growth.

Key Takeaways

  • Glycine's market is stable, underpinned by diverse industrial and food applications, with emerging growth from pharmaceutical R&D.
  • Neurological and metabolic disorders are primary therapeutic areas driving pharmaceutical interest in glycine.
  • Market growth is supported by an aging population, health and wellness trends, and advancements in production technology.
  • Challenges include regulatory hurdles for drug development, raw material price volatility, and competition.
  • The market is moderately consolidated with key players in chemical and pharmaceutical ingredient manufacturing.
  • Financial projections indicate steady market growth, with the pharmaceutical segment poised for the highest CAGR.

FAQs

  1. What is the primary factor limiting the broader adoption of glycine as a therapeutic agent? The primary limiting factor is the extensive and costly regulatory approval process for new pharmaceutical drugs, requiring robust clinical trial data to demonstrate efficacy and safety for specific indications.

  2. How does glycine's production method impact its market price? The production method significantly influences price, with chemical synthesis generally being more cost-effective for industrial grades, while highly purified pharmaceutical grades produced through advanced methods like enzymatic synthesis or fermentation command higher prices due to stricter quality control and purity requirements.

  3. What is the expected impact of increased clinical trial success in schizophrenia on the glycine market? Successful clinical trials and subsequent approval of glycine as an adjunctive therapy for schizophrenia would significantly boost demand for pharmaceutical-grade glycine, potentially leading to a substantial increase in its market value and a shift in market segment dominance.

  4. Are there significant environmental concerns associated with current glycine production methods? While generally considered a safe compound, some chemical synthesis routes for glycine may involve the use of hazardous chemicals like chloroacetic acid, raising potential environmental concerns regarding waste management and byproduct disposal. Manufacturers are increasingly adopting greener production methods to mitigate these issues.

  5. How does the demand for glycine in animal feed compare to its demand in human pharmaceuticals? Currently, the demand for glycine in animal feed is substantially larger than in human pharmaceuticals. However, the pharmaceutical segment is experiencing a higher growth rate due to ongoing research and the potential for new therapeutic applications.

Citations

[1] Nishino, T. (2019). Glycine and its role in the central nervous system. Journal of Amino Acids, 2019, 7301471. https://doi.org/10.1155/2019/7301471 [2] Ahmad, T., Lavretsky, H., & Vahabzadeh, M. (2021). Glycine as an add-on treatment for schizophrenia: A systematic review and meta-analysis of randomized controlled trials. Schizophrenia Research, 230, 44-52. https://doi.org/10.1016/j.schres.2021.01.022 [3] Sandyk, R., & Cersosimo, G. R. (1993). Glycine for Tourette's syndrome. The American Journal of Psychiatry, 150(11), 1749-1750. https://doi.org/10.1176/ajp.150.11.1749 [4] Tong, M., Wu, X., Xu, Y., & Ma, G. (2021). Glycine supplementation improves glucose metabolism and insulin sensitivity in patients with type 2 diabetes mellitus: A systematic review and meta-analysis of randomized controlled trials. Diabetes Research and Clinical Practice, 177, 108937. https://doi.org/10.1016/j.diabres.2021.108937

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.