Drugs Containing Excipient (Inactive Ingredient) AMMONIUM GLYCYRRHIZATE

Branded drugs containing AMMONIUM GLYCYRRHIZATE excipient, and estimated key patent expiration / generic entry dates

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
FSC Laboratories Inc	PRIMSOL	trimethoprim hydrochloride	13551-501	AMMONIUM GLYCYRRHIZATE
Gensco Laboratories LLC	RIZAFILM	rizatriptan benzoate	35781-0600	AMMONIUM GLYCYRRHIZATE
Fresenius Medical Care North America	PHOSLYRA	calcium acetate	49230-643	AMMONIUM GLYCYRRHIZATE

Generic drugs containing AMMONIUM GLYCYRRHIZATE excipient

Company	Ingredient	NDC	Excipient
L Perrigo Company	ibuprofen	0113-0788	AMMONIUM GLYCYRRHIZATE
L Perrigo Company	ibuprofen	0113-1461	AMMONIUM GLYCYRRHIZATE
L Perrigo Company	ibuprofen	0113-2461	AMMONIUM GLYCYRRHIZATE

Ammonium Glycyrrhizate Market Dynamics, Financial Trajectory, Supply Chain, and Patent Outlook

Last updated: August 20, 2026

Ammonium glycyrrhizate is a specialized licorice-derived ingredient used in pharmaceutical formulations, oral-care products, cosmetics, nutraceuticals, and flavor systems. Its market is fragmented, with demand linked to formulation performance rather than to a single branded medicine. Standalone global revenue data is not publicly disclosed, but the financial trajectory is likely to be driven by moderate volume growth, higher-value pharmaceutical grades, regulatory control over glycyrrhizin exposure, and supply volatility in licorice-derived raw materials.

What is ammonium glycyrrhizate and how is it used?

Ammonium glycyrrhizate, also called ammonium glycyrrhizinate or ammonium glycyrrhizin, is the ammonium salt of glycyrrhizic acid, a triterpenoid saponin extracted primarily from licorice root. Its common chemical identifier is CAS 1407-03-0. The compound is water-soluble and has sweetening, flavor-modifying, foaming, emulsifying, and soothing properties. [1]

In pharmaceutical and healthcare products, its principal roles include:

Application	Formulation role	Commercial relevance
Oral liquids and syrups	Sweetener, flavor modifier, soothing agent	Supports palatability and patient adherence
Throat and cough preparations	Demulcent and taste-masking ingredient	Used in lozenges, sprays, and liquid products
Topical products	Skin-conditioning and anti-irritant component	Relevant to dermatology and cosmetic formulations
Ophthalmic and mucosal products	Soothing or anti-inflammatory-support ingredient	Requires high purity and tighter specifications
Nutraceuticals	Botanical active or functional ingredient	Competes with other licorice extracts and glycyrrhizin salts
Oral-care products	Flavor modifier and conditioning ingredient	Used in toothpaste, mouthwash, and specialty products

The distinction between excipient and active ingredient depends on the product’s regulatory positioning. In one formulation, ammonium glycyrrhizate may be an inactive flavoring or processing aid. In another, glycyrrhizin-derived material may be presented as a pharmacologically relevant botanical component.

How large is the ammonium glycyrrhizate market?

No authoritative public source reports a separately audited global market size for ammonium glycyrrhizate. Industry databases often combine it with glycyrrhizic acid, dipotassium glycyrrhizinate, monoammonium glycyrrhizinate, licorice extract, and broader pharmaceutical excipient categories. Those aggregated figures cannot be used as a direct valuation of ammonium glycyrrhizate.

The market has four structural characteristics:

1. It is a niche ingredient market rather than a mass-volume excipient market.
2. Revenue is concentrated among specialty ingredient suppliers and contract manufacturers.
3. Pharmaceutical-grade material commands a premium over food, cosmetic, or technical grades.
4. Demand is diversified across many small and mid-sized finished-product manufacturers.

The most commercially relevant demand centers are China, India, Japan, South Korea, Europe, and North America. China has a strong position in licorice cultivation, botanical extraction, and ingredient manufacturing. Japan and South Korea have established demand in oral-care, pharmaceutical, and cosmetic applications. North American and European buyers place greater emphasis on documentation, traceability, contaminant control, and regulatory compliance.

What is driving ammonium glycyrrhizate demand?

Pharmaceutical formulation growth

Demand benefits from continued use of liquid and mucosal dosage forms. Ammonium glycyrrhizate can improve taste and mouthfeel while contributing functional properties. This is relevant where manufacturers seek alternatives to synthetic flavor systems or want to support a botanical positioning.

The strongest pharmaceutical opportunities are likely to be in:

• Pediatric oral liquids
• Cough and throat preparations
• Herbal and traditional medicines
• Oral-care products
• Dermatological formulations
• Specialty mucosal products

The ingredient does not have the volume profile of microcrystalline cellulose, lactose, starch, or polyethylene glycol. Its value proposition is functional and formulation-specific.

Growth in botanical and “natural” products

Licorice-derived ingredients benefit from demand for botanical products. This demand is strongest in traditional medicine, nutraceuticals, cosmetics, and natural oral-care products. Ammonium glycyrrhizate can be positioned as a purified, standardized derivative rather than as an unstandardized crude extract.

That distinction matters financially. Standardized salt products may obtain better pricing because they offer more consistent assay, solubility, and batch performance. Buyers also reduce formulation variability compared with agricultural extracts.

Taste masking and formulation efficiency

The ingredient’s sweetness and flavor-modifying properties can reduce the need for multiple excipients in certain oral formulations. The economic value is therefore tied to finished-product performance, not only to the cost per kilogram.

In a formulation where a single ingredient contributes sweetness, flavor modification, and soothing characteristics, the supplier may achieve stronger customer retention. Switching can require reformulation, stability testing, sensory evaluation, and regulatory review.

What are the main constraints on market growth?

Glycyrrhizin exposure limits

Glycyrrhizin can cause mineralocorticoid-like effects at excessive exposure, including sodium retention, potassium loss, hypertension, and fluid retention. Regulatory and public-health authorities have therefore focused on total glycyrrhizic acid exposure from foods, supplements, and medicinal products.

The European Union has imposed restrictions on glycyrrhizic acid and ammonium glycyrrhizinate in certain food categories, including labeling and concentration requirements. The European Commission’s rules distinguish products with elevated glycyrrhizic acid content and require consumer warnings in specified circumstances. [2]

These restrictions do not eliminate pharmaceutical demand, but they limit unrestricted use in ingestible products. Manufacturers must manage cumulative exposure, serving size, product category, and label claims.

Agricultural supply and extraction economics

Ammonium glycyrrhizate depends on licorice root supply. Key cost variables include:

• Crop yields and weather
• Root maturity and glycyrrhizic acid content
• Geographic sourcing restrictions
• Extraction energy and solvent costs
• Purification yield
• Heavy-metal, pesticide, and microbiological testing
• Freight and inventory requirements

Licorice species, cultivation region, and extraction process affect assay and impurity profiles. A shortage of high-assay raw material can increase prices for pharmaceutical-grade product even when total licorice supply remains adequate.

Substitution risk

Potential substitutes include dipotassium glycyrrhizinate, glycyrrhizic acid, glycyrrhetinic acid derivatives, sucrose, polyols, steviol glycosides, flavor systems, and other botanical soothing agents.

Substitution is easiest in applications where ammonium glycyrrhizate is used only as a sweetener or flavor modifier. It is harder where the formulation relies on its specific solubility, sensory profile, botanical identity, or pharmacological positioning.

What is the financial trajectory for ammonium glycyrrhizate?

The expected financial trajectory is stable-to-growing, with greater pricing power in pharmaceutical-grade and highly documented material. The market is unlikely to produce the rapid revenue expansion associated with a patented drug or a high-volume excipient platform.

Financial driver	Directional effect	Explanation
Pharmaceutical-grade demand	Positive	Higher specifications and switching costs
Nutraceutical demand	Positive but volatile	Sensitive to consumer trends and regulatory scrutiny
Cosmetic use	Positive	Supports diversification but has lower regulatory barriers
Licorice raw-material costs	Negative when elevated	Reduces supplier margins or increases customer pricing
Regulatory glycyrrhizin limits	Mixed	Restricts some uses while favoring standardized products
Supplier consolidation	Positive for established suppliers	Improves documentation and qualification advantages
Synthetic and non-licorice substitutes	Negative	Limits pricing in basic flavor and sweetening applications
Quality failures or adulteration	Negative	Can trigger recalls, requalification, and customer loss

Supplier economics are likely to divide into three segments:

• Commodity or food-grade material with lower margins and higher price competition.
• Cosmetic and nutraceutical material with moderate margins and broader demand.
• Pharmaceutical-grade material with higher margins, stronger documentation requirements, and longer customer qualification cycles.

Revenue visibility is limited because the ingredient is normally sold through ingredient portfolios rather than as a separately reported business line. Public companies that distribute or manufacture related licorice products generally do not disclose ammonium glycyrrhizate revenue separately.

Which companies and supplier groups compete in ammonium glycyrrhizate?

Competition is fragmented across specialty excipient companies, botanical extract manufacturers, flavor suppliers, and regional chemical producers.

Relevant supplier categories include:

Specialty licorice and sweetener suppliers

Mafco Worldwide is associated with licorice-derived sweetener and flavor-modifying ingredients, including Magnasweet products. Its commercial position is relevant to high-functionality applications where customers value sensory performance and formulation support. [3]

Botanical extract manufacturers

Chinese and Indian extract manufacturers supply glycyrrhizic acid salts, licorice extracts, and related derivatives. These companies compete primarily on price, assay, manufacturing capacity, and export documentation.

Pharmaceutical excipient distributors

Large distributors can compete without owning extraction assets. Their advantages include regional warehousing, quality agreements, regulatory support, and access to finished-dose manufacturers.

Custom manufacturers

Contract manufacturers may produce ammonium glycyrrhizate to customer specifications, including particle size, assay, residual solvents, microbial limits, and packaging configuration. Custom production can strengthen customer retention but requires quality-system investment.

Market share is difficult to calculate because suppliers report under wider categories such as licorice extract, glycyrrhizin, botanical actives, sweeteners, or pharmaceutical excipients.

What is the FDA regulatory and Orange Book status of ammonium glycyrrhizate?

Ammonium glycyrrhizate is not a conventional FDA-approved active pharmaceutical ingredient with an Orange Book product listing. The FDA Orange Book lists approved drug products and associated patents or exclusivity, not ordinary excipients sold for formulation use. [4]

For U.S. products, regulatory treatment depends on the intended use:

• An inactive ingredient must be suitable for the dosage form, route, concentration, and product context.
• A botanical or pharmacologically active product may require a different regulatory basis.
• Food and dietary-supplement uses are subject to separate ingredient and labeling requirements.
• Pharmaceutical manufacturers must maintain supplier qualification, specifications, certificates of analysis, and change-control records.

FDA inactive-ingredient information may provide useful precedent for particular dosage forms, but an ingredient’s presence in one approved product does not automatically establish unrestricted use in every route or concentration.

What patents protect ammonium glycyrrhizate?

The core molecule is an old chemical entity and is not expected to have meaningful composition-of-matter patent protection. Commercial protection is more likely to arise from:

• Specific formulations
• Combination products
• Delivery systems
• Purification methods
• Extraction processes
• Stabilization techniques
• Particle engineering
• Therapeutic methods using glycyrrhizin derivatives

These rights generally protect a product or process rather than the basic ammonium glycyrrhizate molecule.

Patent litigation and Paragraph IV risk

Ammonium glycyrrhizate itself is not an Orange Book drug product and therefore does not normally create a conventional Paragraph IV litigation pathway. Paragraph IV certifications apply to abbreviated new drug applications referencing listed drug patents. [5]

Risk can arise indirectly when the ingredient is incorporated into a branded drug formulation covered by formulation or method-of-use patents. In that case, the relevant patent exposure belongs to the finished dosage form, not to the excipient as a standalone commercial chemical.

Licensing and settlement activity

No major publicly reported licensing or patent settlement market is associated specifically with ammonium glycyrrhizate. Licensing is more likely to occur through private supply agreements, botanical extract partnerships, regional distribution contracts, or finished-product brand transactions.

How strong is the intellectual-property position?

The standalone IP position is weak because:

• The chemical entity is long established.
• Multiple suppliers can produce related salts and extracts.
• The ingredient is not tied to a single innovator drug.
• Substitution is feasible in many noncritical applications.
• Manufacturing know-how is difficult to identify from public patent records alone.

The strongest defensibility lies in execution rather than molecule ownership. A supplier can build commercial protection through validated pharmaceutical manufacturing, reliable agricultural sourcing, low impurity profiles, regulatory files, customer-specific grades, and technical support.

What generic-entry and biosimilar risks exist?

There is no direct biosimilar risk because ammonium glycyrrhizate is a small-molecule salt, not a biologic. There is also no conventional generic-entry event for the excipient itself.

Generic pressure exists at the supplier level. Customers can qualify alternate sources if:

• The specification is not highly customized.
• The new supplier has adequate GMP controls.
• The customer can complete analytical and stability comparability.
• Regulatory documentation is acceptable.
• The price differential justifies switching.

Pharmaceutical-grade customers may maintain dual sourcing, but qualification timelines can be lengthy. This creates some protection for incumbent suppliers without creating monopoly pricing power.

How does ammonium glycyrrhizate compare with competing glycyrrhizin salts?

Attribute	Ammonium glycyrrhizate	Dipotassium glycyrrhizinate	Glycyrrhizic acid	Licorice extract
Solubility	Generally strong in aqueous systems	Strong in aqueous systems	More formulation-dependent	Variable
Standardization	High when purified	High when purified	High	Often lower
Primary use	Sweetening, flavor, soothing, formulation support	Pharmaceutical, cosmetic, and oral-care applications	Active or intermediate ingredient	Botanical and traditional products
Mineral exposure considerations	Ammonium and glycyrrhizin exposure	Potassium and glycyrrhizin exposure	Glycyrrhizin exposure	Variable glycyrrhizin exposure
Batch consistency	Higher than crude extract	Higher than crude extract	High	Dependent on source
Substitution risk	Moderate	Moderate	Moderate	High in nonstandardized uses

The preferred salt depends on route, formulation pH, mineral load, sensory profile, regulatory status, and customer specifications.

What geographic markets offer the strongest growth?

China is likely to remain central to extraction and manufacturing because of its licorice-processing base and regional supply relationships. India has growth potential in botanical pharmaceuticals, nutraceuticals, and contract manufacturing. Japan and South Korea support demand for standardized functional ingredients.

Europe offers premium pricing opportunities but has tighter controls on glycyrrhizin exposure, claims, and labeling. North America has demand in specialty pharmaceuticals, dietary supplements, oral care, and cosmetics, but product classification can materially affect market access.

Geographic expansion depends on more than ingredient registration. Suppliers must address pharmacopeial or customer specifications, GMP documentation, allergen and contaminant controls, customs classification, and local labeling requirements.

What manufacturing and IP barriers affect the market?

The key barriers are manufacturing and quality barriers rather than fundamental patent barriers. Important capabilities include:

• Controlled licorice-root sourcing
• Reproducible extraction
• High-purity salt formation
• Assay and impurity testing
• Residual-solvent control
• Microbiological control
• Stability data
• GMP documentation
• Change-control procedures
• Reliable batch-to-batch color and sensory performance

For pharmaceutical customers, a lower-cost supplier may not be commercially viable until it completes audits, analytical comparison, process qualification, and regulatory documentation. These requirements create a practical barrier to entry.

Key Takeaways

• Ammonium glycyrrhizate is a niche, licorice-derived specialty ingredient used in pharmaceutical, oral-care, cosmetic, nutraceutical, and flavor applications.
• Public sources do not provide a separately audited global market size or company-level revenue figure for the ingredient.
• Financial growth is likely to be moderate, with the strongest margins in pharmaceutical-grade and standardized material.
• Demand is supported by liquid medicines, botanical products, taste masking, and natural-positioned formulations.
• Regulatory controls on glycyrrhizin exposure limit some ingestible applications.
• Raw-material availability, assay consistency, and extraction economics are the main supply risks.
• The core molecule has limited standalone patent protection.
• Orange Book, Paragraph IV, biosimilar, and branded-drug settlement risks are generally indirect rather than inherent to the excipient.
• Supplier defensibility depends on GMP quality, documentation, validated processes, sourcing, and customer qualification.
• Dipotassium glycyrrhizinate, glycyrrhizic acid, licorice extract, and synthetic flavor systems are the principal competitive alternatives.

FAQs

Is ammonium glycyrrhizate the same as ammonium glycyrrhizinate?

The terms are commonly used interchangeably for the ammonium salt of glycyrrhizic acid. Supplier specifications should control the exact nomenclature, assay basis, and impurity limits.

Is ammonium glycyrrhizate approved as an FDA drug?

It is not generally treated as a standalone FDA-approved drug product. Its regulatory status depends on whether it is used as an inactive ingredient, food ingredient, dietary-supplement component, cosmetic ingredient, or active botanical constituent.

Can ammonium glycyrrhizate be replaced by dipotassium glycyrrhizinate?

In some formulations, yes. The substitution requires assessment of solubility, pH, mineral contribution, taste, stability, assay, route of administration, and regulatory documentation.

Does ammonium glycyrrhizate have a high risk of patent infringement?

Standalone infringement risk is generally limited because the molecule is established and widely available. Risk can arise from patented finished formulations, delivery systems, purification processes, or therapeutic uses.

What determines the price of pharmaceutical-grade ammonium glycyrrhizate?

Price is primarily affected by assay, purity, GMP status, batch size, documentation, licorice-root costs, extraction yield, testing requirements, packaging, geographic destination, and customer qualification status.

References

1. National Center for Biotechnology Information. (n.d.). PubChem compound summary for ammonium glycyrrhizate. PubChem. https://pubchem.ncbi.nlm.nih.gov/

2. European Commission. (2008). Commission Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods. EUR-Lex. https://eur-lex.europa.eu/

3. Mafco Worldwide Corporation. (n.d.). Magnasweet licorice-derived flavor modifier products. https://www.mafcolicorice.com/

4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

5. U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application submissions: Patent certifications and the Paragraph IV process. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/anda-submissions-legal-and-regulatory-requirements