Last Updated: August 2, 2026

glycine - Profile


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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.

Summary for glycine
US Patents:0
Tradenames:2
Applicants:4
NDAs:5

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

Investment Scenario and Fundamentals Analysis for Glycine as a Pharmaceutical Asset

Last updated: February 23, 2026

What is the Market Position of Glycine?

Glycine, a non-essential amino acid, is primarily utilized in food, cosmetic, and pharmaceutical industries. Its application in pharmaceuticals includes use as an excipient, cryoprotectant, and in treatments for certain neurological and metabolic disorders. Although not a blockbuster drug on its own, interest persists in its role as a biomodulator and in developing new therapeutic formulations.

Market size estimates for glycine are approximately $250 million annually, driven mainly by demand in China, Japan, and Europe. The compound’s growth rate lingers around 3-4% per year, with pharmaceutical applications growing modestly due to ongoing research into neurodegenerative and metabolic diseases.

What Are the Supply Chain and Manufacturing Fundamentals?

Glycine production generally occurs through two methods:

  • Carboxylation of ammonia and formaldehyde (laboratory scale): Limited corporate use due to high costs.
  • Industrial synthesis via Strecker synthesis (dominant method): Utilizes chloroacetaldehyde, ammonia, and hydrogen cyanide, producing glycine at scale.

Global capacity exceeds 30,000 metric tons annually, with key manufacturers in China (roughly 60% of global supply), India, and the U.S. (smaller scale). Price points hover around $10-$15 per kilogram, depending on purity and volume. The market's reliance on Chinese supply introduces risks related to geopolitical tensions, quality consistency, and regulatory changes.

What Regulatory and Scientific Trends Influence Investment?

Glycine's safety profile is well established, with FDA approval as a dietary supplement and food additive. No specific pharmaceuticals currently list glycine as an active ingredient, but ongoing research explores its therapeutic potential:

  • Neurodegenerative diseases (e.g., Parkinson's, Alzheimer's): Glycine functions as an inhibitory neurotransmitter, with clinical trials examining its role in symptom management.
  • Metabolic conditions: Its involvement in glucose metabolism supports investigations into diabetes adjunct therapy.
  • Cryoprotectant applications: Limited to cryopreservation research, with broad growth prospects in biobanking.

Regulatory barriers are minimal, primarily involving good manufacturing practices (GMP) standards, purity specifications, and environmental safety controls.

What Are Key Investment Risks and Incentives?

Risks:

  • Supply dependence: Overreliance on Chinese manufacturing exposes investors to geopolitical and environmental risk.
  • Market scale: The overall market for glycine remains niche within pharmaceuticals, constraining growth potential.
  • Research outcomes: Unpublished or negative results from clinical trials could negate pharmaceutical applications.

Incentives:

  • Growing biotech investments: Neurodegenerative and metabolic therapies attract increasing R&D funding.
  • Emerging formulations: Novel drug delivery systems could expand glycine’s pharmaceutical use.
  • Patent protection: Developing proprietary formulations or delivery mechanisms offers differentiation and potential exclusivity.

How Do Competitive Dynamics and Innovation Impact the Outlook?

Limited patentability restricts glycine's commoditization, but specialized formulations or delivery methods can yield proprietary advantages. Competition in supply is intense, with manufacturers producing high-purity glycine for multiple industries. Innovation centers on:

  • Developing sustained-release formulations for neurological disorders.
  • Enhancing extraction and synthesis efficiency to reduce costs.
  • Exploring glycine derivatives with higher potency or bioavailability.

Investors should monitor regulatory changes, scientific publications, and clinical trial pipelines for emerging therapies involving glycine.

What Are Strategic Recommendations?

  • Invest in firms developing proprietary formulations that leverage glycine’s therapeutic properties.
  • Consider suppliers with certified quality controls, diversified geographic footprint, and capacity expansion plans.
  • Track clinical trial data relevant to neurodegenerative and metabolic disorders for evidence of increased pharmaceutical demand.
  • Evaluate partnerships with biotech firms exploring glycine-related drug delivery systems.

Key Takeaways

  • Glycine has a niche market primarily driven by demand as an excipient and in experimental therapeutics.
  • Supply chain dependence on China introduces geopolitical and quality risks.
  • Scientific advancements and clinical trials targeting neurological and metabolic diseases could expand pharmaceutical applications.
  • The relatively low market size limits high-growth potential but offers stability within niche segments.
  • Innovation in formulations and delivery mechanisms remains critical for value creation.

FAQs

1. What is the outlook for glycine markets outside food and supplements? The pharmaceutical use remains niche; future growth depends heavily on clinical research outcomes and formulation innovations.

2. Which regions represent the highest growth opportunities? China leads in supply, while Europe and North America focus on research and niche pharmaceutical applications.

3. Can glycine become a primary active pharmaceutical ingredient? Current data suggest no; it remains mainly an excipient and supplement, with potential in adjunct therapies.

4. What are the main manufacturing challenges? Maintaining high purity standards at scale, reducing reliance on Chinese capacity, and ensuring environmental compliance.

5. How does research impact the valuation of glycine-related assets? Positive clinical trial results or successful proprietary formulation development can significantly increase valuation and market interest.


References

[1] MarketWatch. (2022). Glycine market size, share, growth. https://www.marketwatch.com

[2] Grand View Research. (2021). Amino acids market size. https://www.grandviewresearch.com

[3] Food and Drug Administration (FDA). (2020). Approved food additives. https://www.fda.gov

[4] Research articles on glycine applications. (2022). Journal of Neurochemistry. https://jnn.sagepub.com

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