Drugs Containing Excipient (Inactive Ingredient) ANHYDROUS DEXTROSE

Branded drugs containing ANHYDROUS DEXTROSE excipient, and estimated key patent expiration / generic entry dates

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Pfizer Laboratories Div Pfizer Inc	ZAVZPRET	zavegepant	0069-3500	ANHYDROUS DEXTROSE	2028-03-09
Merck Sharp & Dohme LLC	NOXAFIL	posaconazole	0085-1328	ANHYDROUS DEXTROSE
Haleon US Holdings LLC	FLONASE SENSIMIST	fluticasone furoate	0135-0615	ANHYDROUS DEXTROSE	2028-07-15
Haleon US Holdings LLC	FLONASE SENSIMIST	fluticasone furoate	0135-0616	ANHYDROUS DEXTROSE	2028-07-15
Hikma Pharmaceuticals USA Inc	LABETALOL HCL IN SODIUM CHLORIDE	labetalol hydrochloride	0143-9363	ANHYDROUS DEXTROSE

Generic drugs containing ANHYDROUS DEXTROSE excipient

Company	Ingredient	NDC	Excipient
Pfizer Laboratories Div Pfizer Inc	zavegepant	0069-3500	ANHYDROUS DEXTROSE
Merck Sharp & Dohme LLC	posaconazole	0085-1328	ANHYDROUS DEXTROSE
L Perrigo Company	triamcinolone acetonide	0113-0443	ANHYDROUS DEXTROSE
L Perrigo Company	triamcinolone acetonide	0113-7005	ANHYDROUS DEXTROSE
Haleon US Holdings LLC	fluticasone furoate	0135-0615	ANHYDROUS DEXTROSE

Anhydrous Dextrose Pharmaceutical Excipient Market: Dynamics, Pricing, Supply, and Financial Outlook

Last updated: August 17, 2026

Anhydrous dextrose is a mature, high-volume carbohydrate excipient with limited product differentiation and modest standalone pricing power. Its financial trajectory is driven primarily by pharmaceutical manufacturing volumes, injectable and oral-solid-dose demand, corn and energy costs, drying capacity, quality compliance, and regional supply reliability. Public companies generally do not report anhydrous dextrose as a separate revenue line, so precise market-size and margin estimates are unavailable from audited filings.

The market has attractive stability but limited intellectual-property protection. Competitive advantage comes from compendial compliance, validated manufacturing, low bioburden, particle engineering, regulatory documentation, and supply continuity rather than patents.

What is anhydrous dextrose and how is it used in pharmaceuticals?

Anhydrous dextrose is crystalline D-glucose containing little or no water of crystallization. It is also known as dextrose, glucose anhydrous, or D-glucose, depending on the applicable pharmacopeial and regulatory terminology.

Its principal pharmaceutical functions are:

Function	Typical use
Bulking agent	Tablets, powders, sachets, and oral solid dosage forms
Sweetener	Oral liquids, chewables, lozenges, and powders
Tonicity agent	Parenteral and ophthalmic formulations
Carbohydrate source	Infusion products and nutrition formulations
Carrier or processing aid	Dry blends, granulations, and selected inhalation or specialty formulations
Stabilization support	Certain biological, protein, and lyophilized products, subject to formulation-specific validation

Dextrose monohydrate is often preferred where a hydrated crystalline form is acceptable. Anhydrous dextrose is more relevant when formulators need lower water content, tighter moisture control, or a defined dry-solid composition.

The product should not be confused with dextrose solution, which is a finished pharmaceutical preparation, or with dextrose monohydrate, which has a different molecular water content and may have different processing characteristics.

How large is the pharmaceutical anhydrous dextrose market?

No authoritative public source reports a separately audited global market size for pharmaceutical-grade anhydrous dextrose. Commercial market reports often combine anhydrous dextrose with dextrose monohydrate, food-grade glucose, intravenous dextrose solutions, or broader carbohydrate excipients. Those categories are not interchangeable.

The addressable market is best analyzed through demand pools:

1. Parenteral products and hospital infusion manufacturing.
2. Oral solid dosage products using carbohydrate fillers or sweeteners.
3. Nutritional and rehydration products.
4. Contract manufacturing and generic pharmaceutical production.
5. Specialty formulations requiring low moisture or dry-state stability.

Pharmaceutical demand is smaller than food and beverage demand, but pharmaceutical-grade material has higher documentation and qualification requirements. Food-grade supply cannot automatically substitute for pharmaceutical-grade supply because identity, impurity limits, microbial controls, traceability, change control, and quality systems must meet the relevant pharmacopeial and customer standards.

What factors are driving demand for anhydrous dextrose?

Demand is tied to formulation volumes rather than prescription-drug brand growth.

Generic and contract manufacturing demand

Anhydrous dextrose is used in products with relatively low formulation complexity. Growth in generic tablets, oral powders, hospital products, and contract manufacturing can increase demand, but volume growth is usually incremental.

Parenteral and nutrition products

Dextrose is widely used in parenteral nutrition and infusion products. The active pharmaceutical ingredient in these products is frequently dextrose itself, while the material may still be sourced under pharmaceutical-grade excipient and active-ingredient quality systems depending on the product and jurisdiction.

Hospital shortages, tender purchasing, and manufacturing concentration affect procurement more than consumer demand. Injectable applications impose tighter requirements for endotoxins, particulate matter, microbial control, and container-closure compatibility.

Moisture-sensitive formulation design

Anhydrous dextrose can be selected when water of crystallization is undesirable. It may support dry blending, moisture-sensitive active ingredients, or tighter control of tablet weight and composition. The benefit depends on particle size, flow, compressibility, hygroscopicity, and the rest of the formulation.

Nutrition and rehydration products

Oral rehydration salts and nutritional products use glucose as a functional carbohydrate. These applications can create volume, but their price sensitivity is higher than that of regulated injectable products.

Which companies supply pharmaceutical-grade anhydrous dextrose?

The supplier field includes integrated carbohydrate producers, excipient specialists, and laboratory or regional distributors. The relevant competitive groups include:

Supplier group	Representative companies	Competitive basis
Integrated starch and carbohydrate producers	Roquette, Cargill, Ingredion, Tereos, ADM and regional producers	Corn or starch access, scale, purification, drying, global logistics
Pharmaceutical excipient suppliers	DFE Pharma and specialized excipient distributors	Documentation, formulation support, qualification, regional inventory
Specialty and laboratory distributors	Merck, Avantor, Spectrum Chemical, Thermo Fisher and regional distributors	Small-pack supply, certificates, catalog breadth, local fulfillment
Regional pharmaceutical-material producers	Producers in China, India, Europe, and Latin America	Cost, local registration, domestic supply, tender access

Roquette is a major global supplier of pharmaceutical-grade carbohydrate excipients and markets glucose and dextrose products for pharmaceutical applications. Other large starch processors may manufacture suitable material, but product-specific pharmaceutical status, compendial conformity, and customer qualification must be verified for each grade.

Supplier selection is usually based on more than price. Buyers review:

• USP-NF, Ph. Eur., or other compendial conformity.
• GMP status and quality-system maturity.
• Residual solvents and elemental impurities.
• Bioburden and endotoxin controls.
• Particle-size distribution and bulk density.
• Moisture and water activity.
• Packaging, retest period, and storage conditions.
• Change-notification procedures.
• Audit history and supply-continuity plans.

How is the price of anhydrous dextrose determined?

Pricing is influenced by commodity and pharmaceutical factors.

Feedstock exposure

Most industrial dextrose is derived from starch, commonly corn starch. The cost base therefore reflects corn, starch conversion, enzymes, utilities, labor, packaging, freight, and plant utilization. Energy prices are significant because hydrolysis, purification, concentration, crystallization, and drying require process energy.

Grade premium

Pharmaceutical-grade material commands a premium over food-grade material because of testing, segregation, validation, documentation, quality assurance, and regulatory support. The premium is not fixed. It varies by order size, region, packaging, customer qualification, and supply conditions.

Form and specification

Anhydrous product can command a premium over standard dextrose monohydrate when it requires additional crystallization, drying, moisture control, or tighter particle engineering. The commercial premium depends on whether the customer requires a dedicated grade or accepts a broadly specified material.

Contract structure

Large pharmaceutical customers commonly use annual or multiyear supply arrangements with price-adjustment mechanisms. Smaller buyers purchase through distributors at higher unit prices. Spot pricing is more exposed to freight and regional availability.

What is the financial trajectory for anhydrous dextrose suppliers?

The financial trajectory is best characterized as stable, low-to-moderate growth with margin volatility.

Financial driver	Likely effect
Pharmaceutical volume growth	Supports gradual volume expansion
Corn and starch costs	Raises or lowers cost of goods
Energy and drying costs	Directly affects conversion margins
Freight and packaging	Creates regional price differences
Qualification barriers	Protects incumbent supply relationships
Commodity competition	Limits long-term price expansion
Capacity utilization	Determines operating leverage
Regulatory compliance	Raises fixed costs but supports pricing
Product mix	Higher-specification grades improve margins
Supply disruptions	Can increase short-term pricing but damage reliability

Integrated producers have the strongest cost position because they control or closely source starch inputs and can use shared infrastructure across food, nutrition, industrial, and pharmaceutical products. Their earnings exposure to anhydrous dextrose is diluted across larger carbohydrate portfolios.

Excipient specialists can earn higher gross margins through technical service, formulation support, smaller-lot supply, and regulatory documentation. They generally lack the same feedstock advantage and may depend on upstream producers.

The commercial profile is defensive rather than high growth. There is limited evidence that anhydrous dextrose alone can materially change the financial trajectory of a diversified starch or excipient company. The product is more valuable as part of a qualified portfolio than as a standalone growth engine.

What patents protect anhydrous dextrose?

Anhydrous dextrose is a known chemical substance with extensive prior art and no meaningful composition-of-matter patent protection for the base molecule. The product is a commodity or near-commodity excipient from an intellectual-property perspective.

Potentially protectable areas include:

• Specialized particle-size distributions.
• Direct-compression grades.
• Co-processed excipients containing dextrose.
• Low-endotoxin or low-bioburden processing.
• Crystallization and drying methods.
• Granulation and flow-enhancement processes.
• Formulations using dextrose with a particular active ingredient.
• Packaging or moisture-control systems.

These rights are usually narrow, process-specific, formulation-specific, or dependent on a particular physical specification. They do not generally prevent another qualified manufacturer from producing standard anhydrous dextrose.

How strong is the patent estate for anhydrous dextrose?

The patent estate is weak for the base excipient and stronger only in specialized applications. Freedom-to-operate risk is normally concentrated in a customer’s finished formulation, a co-processed excipient, or a proprietary manufacturing process.

Patent term analysis must be performed at the individual patent level. No single Orange Book-listed patent protects pharmaceutical-grade anhydrous dextrose as a general product.

What is the FDA regulatory status of anhydrous dextrose?

Dextrose has established pharmaceutical use and is recognized in major compendia, including the USP-NF and European Pharmacopoeia, subject to the applicable monograph and grade requirements.

The regulatory status depends on use:

• As an excipient, it is reviewed as part of the finished drug application.
• As the active component of an infusion or nutrition product, it is subject to drug-product requirements for identity, strength, purity, sterility, stability, and manufacturing controls.
• For products marketed in the United States, the finished product may be subject to an NDA, ANDA, or other applicable pathway.
• Excipients do not receive independent FDA approval in the same manner as finished drugs.

The FDA Inactive Ingredient Database can support precedent analysis for inactive use, route, and dosage form. Database presence does not eliminate the need for product-specific formulation and safety justification (FDA, n.d.-a).

What is the Orange Book status of anhydrous dextrose?

Anhydrous dextrose as an excipient has no standalone Orange Book listing. The Orange Book identifies approved drug products, therapeutic equivalence information, and certain patent and exclusivity data for listed products. It does not create a general patent registry for excipients.

Dextrose-containing finished products may appear in FDA drug databases, but those entries do not establish exclusivity over the excipient itself. A generic applicant using anhydrous dextrose would generally face product-specific requirements rather than an excipient-based Orange Book barrier.

When does anhydrous dextrose lose exclusivity?

Anhydrous dextrose has no practical molecule-level exclusivity period to lose. It is an established substance available from multiple producers.

Relevant exclusivity may instead attach to:

• A branded finished drug containing dextrose.
• A proprietary formulation.
• A specific method of use.
• A co-processed excipient.
• A manufacturing process.
• A regulatory designation for a finished product.

Those rights expire according to the individual patent, regulatory exclusivity, and jurisdiction. The expiration of one supplier’s process patent would not necessarily affect the broader market.

Are there Paragraph IV challenges involving anhydrous dextrose?

There is no general Paragraph IV challenge directed to anhydrous dextrose as an excipient. Paragraph IV certifications apply to patents listed for an approved reference drug in the FDA Orange Book. A generic product containing dextrose could raise Paragraph IV issues against patents covering the finished dosage form or method of use, but the challenge would not ordinarily target standard anhydrous dextrose.

The main generic-entry risks are therefore:

1. Finished-product patent litigation.
2. Formulation differences affecting bioequivalence.
3. Supplier qualification and manufacturing changes.
4. Injectable quality and sterility requirements.
5. Regulatory concerns caused by excipient variability.

What manufacturing and geographic barriers affect supply?

Manufacturing barriers are operational and regulatory rather than patent-based.

Process barriers

Commercial production requires controlled starch hydrolysis, purification, concentration, crystallization, separation, drying, milling, and packaging. Pharmaceutical production adds segregation, validated cleaning, environmental monitoring, traceability, and release testing.

Geographic exposure

Supply is influenced by:

• Corn and starch availability.
• Water and energy costs.
• Regional pharmaceutical manufacturing capacity.
• Port and freight conditions.
• Import registration requirements.
• Local content or tender rules.
• Customer-approved manufacturing sites.

North America and Europe have established starch and pharmaceutical-material infrastructure. Asia has significant manufacturing capacity and growing domestic pharmaceutical demand. Regional sourcing can reduce freight exposure but may require new supplier qualification and regulatory documentation.

Dual sourcing is difficult when the customer requires identical particle properties, validated performance, and a long change-control history. A second supplier may meet the monograph but fail to match compression, flow, dissolution, or fill-weight performance.

What litigation and settlement risks affect the market?

There is no broad litigation wave over the base excipient. Litigation risk is normally product-specific.

Potential disputes include:

• Alleged infringement by a co-processed excipient.
• Use of a proprietary particle-size or granulation process.
• Contract and supply-quality claims.
• Contamination, recall, or batch-release disputes.
• Finished-drug patents covering dextrose-containing formulations.
• Trade-secret claims involving crystallization or drying conditions.

Settlement agreements are more likely in finished-drug patent disputes than in the commodity excipient market. A supplier should review formulation patents and process claims when selling a customized grade or manufacturing under a customer’s technical specification.

How does anhydrous dextrose compare with dextrose monohydrate?

Attribute	Anhydrous dextrose	Dextrose monohydrate
Water content	Lower, with no stoichiometric crystal water	Contains water of crystallization
Main formulation rationale	Moisture control and dry-state composition	Broad, established use and cost efficiency
Processing	May require tighter drying and moisture control	Often simpler and widely available
Cost	Can carry a specification or processing premium	Often more commoditized
Regulatory familiarity	Established, but grade-specific	Very broad historical use
Substitution	Requires formulation and process validation	Not automatically interchangeable
Commercial risk	Specialty-grade qualification	Larger supplier and volume base

A switch between the two forms can change tablet weight, density, dissolution, stability, water activity, and active-ingredient compatibility. Substitution should be treated as a formulation change, not a routine procurement change.

What generic launch risks exist for products using anhydrous dextrose?

Generic launch risk is usually low at the excipient level and moderate at the finished-product level.

A generic manufacturer can generally source nonproprietary anhydrous dextrose from multiple qualified suppliers. The harder issues are:

• Matching the reference product’s excipient composition.
• Demonstrating bioequivalence.
• Controlling impurities and moisture.
• Meeting injectable specifications.
• Maintaining supply after approval.
• Avoiding a formulation patent or method-of-use patent.

For simple oral products, excipient substitution is often manageable. For sterile or highly sensitive products, small changes in particle characteristics or impurity profiles can create development and regulatory delays.

Key Takeaways

• Anhydrous dextrose is a mature pharmaceutical excipient with stable demand and limited standalone growth.
• Public companies do not generally disclose separate revenue, margin, or market-share data for the product.
• Financial performance depends on starch, corn, energy, drying, freight, capacity utilization, and pharmaceutical-grade compliance.
• The base substance has no meaningful composition-of-matter patent barrier.
• Specialized particle engineering, co-processed excipients, formulations, and manufacturing methods may be patent-protected.
• Anhydrous dextrose has no standalone Orange Book exclusivity and is not the subject of a general Paragraph IV market challenge.
• Supplier qualification, low-bioburden processing, documentation, and consistent physical properties are the principal commercial barriers.
• Dextrose monohydrate is not automatically substitutable for anhydrous dextrose.
• The market favors integrated carbohydrate producers for cost and supply scale, while excipient specialists can capture value through documentation and technical support.
• Generic-entry risk is concentrated in the finished drug, not in the standard excipient.

Frequently Asked Questions

Is anhydrous dextrose the same as glucose anhydrous?

Yes. Anhydrous dextrose is the D-isomer of glucose in a form that does not contain the stoichiometric water of crystallization found in dextrose monohydrate.

Can food-grade dextrose be used in a pharmaceutical product?

Not automatically. The manufacturer must demonstrate that the material meets the finished product’s regulatory, compendial, impurity, microbial, and supply-quality requirements.

Is anhydrous dextrose suitable for direct compression?

It can be used in direct-compression formulations when its particle size, flow, density, and compactibility meet the formulation requirements. Product-specific testing is necessary.

Does anhydrous dextrose have an FDA-approved excipient status?

FDA does not generally approve excipients as standalone products. Their acceptability is assessed in the context of a finished drug application, supported by prior use, safety information, and product-specific data.

Which factors can cause anhydrous dextrose shortages?

The main causes are plant shutdowns, contamination events, crop or starch disruptions, energy constraints, freight interruptions, quality failures, and loss of a qualified manufacturing site.

References

1. U.S. Food and Drug Administration. (n.d.-a). Inactive Ingredient Database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

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

3. United States Pharmacopeial Convention. (2024). United States Pharmacopeia and National Formulary, General Chapter <1078>, Good manufacturing practices for bulk pharmaceutical excipients. United States Pharmacopeial Convention.

4. European Directorate for the Quality of Medicines & HealthCare. (2023). European Pharmacopoeia, 11th edition. Council of Europe.

5. International Council for Harmonisation. (2022). ICH Q7: Good manufacturing practice guide for active pharmaceutical ingredients. https://www.ich.org/page/quality-guidelines

6. Roquette. (n.d.). Pharmaceutical excipients and glucose-based ingredients. https://pharma.roquette.com/