Drugs Containing Excipient (Inactive Ingredient) DEXTROSE MONOHYDRATE

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

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Pharmacia & Upjohn Company LLC	ZYVOX	linezolid	0009-4992	DEXTROSE MONOHYDRATE
Pharmacia & Upjohn Company LLC	ZYVOX	linezolid	0009-5137	DEXTROSE MONOHYDRATE
Pharmacia & Upjohn Company LLC	ZYVOX	linezolid	0009-7807	DEXTROSE MONOHYDRATE
Wyeth Pharmaceuticals Inc a subsidiary of Pfizer Inc	ZOSYN	piperacillin sodium and tazobactam sodium	0206-2409	DEXTROSE MONOHYDRATE

Generic drugs containing DEXTROSE MONOHYDRATE excipient

Company	Ingredient	NDC	Excipient
Pharmacia & Upjohn Company LLC	linezolid	0009-4992	DEXTROSE MONOHYDRATE
Pharmacia & Upjohn Company LLC	linezolid	0009-5137	DEXTROSE MONOHYDRATE
Pharmacia & Upjohn Company LLC	linezolid	0009-7807	DEXTROSE MONOHYDRATE
Hikma Pharmaceuticals USA Inc	clindamycin in percent dextrose	0143-9267	DEXTROSE MONOHYDRATE

Dextrose Monohydrate Pharmaceutical Excipient Market: Market Dynamics, Pricing, Supply Chain and Financial Trajectory

Last updated: August 13, 2026

Dextrose monohydrate is a mature, high-volume pharmaceutical excipient and active pharmaceutical ingredient used in oral solids, parenteral nutrition, intravenous solutions, and manufacturing media. Its financial profile is driven by glucose economics rather than patent protection. Demand is stable, but margins vary with corn or wheat feedstock costs, energy, freight, crystallization capacity, quality compliance, and sterile-product demand.

The market has limited public revenue transparency because major producers generally report dextrose within broader starch, sweetener, carbohydrate, or pharmaceutical excipient segments. The strongest commercial opportunities are in pharmaceutical-grade supply, low-endotoxin material, regional manufacturing redundancy, and validated grades for injectable and biologic manufacturing.

What is dextrose monohydrate and how is it used pharmaceutically?

Dextrose monohydrate is crystalline D-glucose containing one molecule of water of crystallization. It is commonly identified as glucose monohydrate and has CAS Registry Number 5996-10-1. The compound is distinct from anhydrous dextrose, which contains no crystallization water.

Attribute	Dextrose monohydrate
Chemical name	D-glucose monohydrate
Common pharmaceutical name	Dextrose monohydrate
CAS number	5996-10-1
Primary sources	Corn, wheat and other starch feedstocks
Main functions	Bulking agent, sweetener, tonicity agent, carbohydrate source, fermentation substrate
Key dosage forms	Tablets, powders, oral liquids, injections and parenteral nutrition
Relevant quality standards	USP-NF, Ph. Eur., BP and applicable national pharmacopoeias
Patent dependence	Low for the substance itself
Main commercial risk	Commodity input costs and qualified supply capacity

Dextrose monohydrate is used as:

• A carbohydrate and energy source in intravenous dextrose solutions.
• A tonicity-adjusting agent in injectable formulations.
• A diluent and bulking agent in tablets, powders and sachets.
• A sweetener in oral liquids and chewable products.
• A fermentation or cell-culture carbon source.
• A process aid in pharmaceutical and biotechnology manufacturing.

The excipient may be sold in different particle-size distributions, purity classes and packaging configurations. Injectable applications require tighter control of bioburden, endotoxins, particulate matter, elemental impurities and microbial contamination than many oral-solid applications.

How large is the pharmaceutical dextrose monohydrate market?

No authoritative public source reports a standalone global revenue figure for pharmaceutical-grade dextrose monohydrate. Public market estimates often combine dextrose, glucose, glucose syrup, anhydrous glucose, food-grade products and industrial grades. Those categories have materially different prices and specifications.

The pharmaceutical market is best analyzed as a segment of the broader glucose and carbohydrate ingredients industry.

Market layer	Demand profile	Pricing profile	Competitive intensity
Food-grade glucose and dextrose	Very high volume	Low to moderate	High
Pharmaceutical oral-grade dextrose	Moderate volume	Moderate	Moderate
Injectable-grade dextrose	Lower volume	Higher	Lower
Bioprocess-grade glucose	Lower volume	High	Moderate
Custom or validated grades	Low volume	Highest	Lower

Pharmaceutical-grade material typically commands a premium over food-grade material because of:

• Pharmacopoeial testing.
• GMP documentation.
• Lot traceability.
• Audit support.
• Controlled microbiological quality.
• Supplier qualification requirements.
• Stability and change-control obligations.
• Specialized packaging and release procedures.

The value pool is therefore concentrated in qualified, higher-specification material rather than total tonnage.

What is driving demand for dextrose monohydrate?

Growth in parenteral nutrition and hospital injectable products

Dextrose remains a standard carbohydrate source in parenteral nutrition and intravenous fluid products. FDA-approved products include dextrose injections at concentrations such as 5%, 10%, 20% and 50%, depending on the product and indication. These products are listed in FDA labeling databases and DailyMed records.

Demand is supported by:

• Hospital use of basic IV fluids.
• Parenteral nutrition.
• Rehydration and caloric support.
• Manufacturing of premixed solutions.
• Regional stockpiling of critical injectable medicines.

Injectable demand is less discretionary than consumer sweetener demand. However, it is also more exposed to manufacturing interruptions because sterile-product manufacturers require qualified raw-material sources and cannot always substitute suppliers quickly.

Expansion of oral solid-dose manufacturing

Dextrose monohydrate is used as a filler and carrier in tablets, powders and granules. Its value in oral products is usually lower than in injectable applications, but the addressable volume is broader.

Demand is linked to:

• Generic drug production.
• Over-the-counter products.
• Nutritional supplements.
• Pediatric formulations.
• Effervescent products.
• Direct-compression and wet-granulation formulations.

The material competes with lactose, mannitol, sorbitol, microcrystalline cellulose and starch-based excipients. Selection depends on compressibility, taste, hygroscopicity, particle size, compatibility and cost.

Biologics and bioprocessing

Glucose is used in some cell-culture, fermentation and microbial-processing systems. Bioprocess customers may require higher documentation, tighter impurity controls and lot-to-lot consistency than conventional oral-solid manufacturers.

This segment can generate stronger margins but requires:

• Validated analytical methods.
• Extensive supplier qualification.
• Defined change-control procedures.
• Extractables and leachables documentation where applicable.
• Secure supply and continuity planning.
• Consistent performance in the customer’s process.

Bioprocess demand is commercially attractive but technically demanding. It is not interchangeable with standard food-grade dextrose.

Which factors determine dextrose monohydrate pricing?

Dextrose monohydrate pricing is mainly a cost-plus and qualification-based market. The primary variables are feedstock, energy, plant utilization and customer specification.

Feedstock and energy costs

Manufacturers generally convert starch into glucose through hydrolysis, purification, concentration and crystallization. Corn and wheat prices therefore affect the cost base. Electricity, steam, water and natural gas are important because evaporation and crystallization are energy-intensive.

A simplified cost structure is:

Cost component	Commercial impact
Corn or wheat starch	Major variable cost
Enzymes and processing aids	Moderate cost
Steam and electricity	Significant conversion cost
Water and wastewater treatment	Important for high-purity production
Labor and quality control	Higher for pharmaceutical grades
Packaging and freight	Material for global shipments
Regulatory compliance	Fixed cost spread across qualified volume

Commodity dextrose prices generally move with agricultural and energy cycles. Pharmaceutical-grade prices are less volatile after qualification because switching suppliers creates regulatory and operational costs.

Purity and specification premiums

Price premiums are associated with:

• USP-NF or Ph. Eur. compliance.
• Low endotoxin levels.
• Low microbial counts.
• Low ash and mineral content.
• Controlled heavy metals and elemental impurities.
• Defined particle-size distribution.
• Low color and high assay.
• Validated packaging.
• Dedicated or controlled production areas.

The greatest premium generally applies to injectable and bioprocess grades. Oral-grade pharmaceutical dextrose is more exposed to competitive substitution.

Logistics and regional supply

Dextrose monohydrate is a relatively high-volume, low-to-moderate value-per-kilogram material. Freight can materially affect delivered cost, especially for smaller pharmaceutical shipments. Local or regional production is commercially valuable when customers need short lead times, dual sourcing or reduced inventory.

Supply-chain disruption risks include:

• Crop failures.
• Export restrictions.
• Port congestion.
• Energy-price spikes.
• Plant shutdowns.
• Contamination events.
• Regulatory inspection findings.
• Packaging shortages.

Who are the major dextrose monohydrate suppliers?

The supplier landscape includes integrated starch processors, carbohydrate manufacturers and specialist pharmaceutical excipient companies. Publicly visible participants and relevant supplier groups include:

Supplier or group	Relevant capability
Cargill	Starch, sweetener and pharmaceutical carbohydrate products
Ingredion	Starches, glucose products and pharmaceutical excipient materials
Roquette	Pharmaceutical excipients, glucose and carbohydrate products
ADM	Corn-based starches and carbohydrate ingredients
Tereos	Starch, glucose and pharmaceutical carbohydrate products
Südzucker Group	Sugar and carbohydrate ingredients, including pharmaceutical materials
DFE Pharma	Pharmaceutical excipient distribution and formulation support
Regional starch manufacturers	Lower-cost supply and regional redundancy

The competitive distinction is not simply production volume. Pharmaceutical buyers assess:

• GMP maturity.
• Pharmacopoeial compliance.
• Audit history.
• Change-control performance.
• Regulatory support.
• Technical service.
• Supply continuity.
• Batch consistency.
• Geographic redundancy.

Integrated producers have an advantage in feedstock control and scale. Specialist suppliers can compete through documentation, technical support, regional inventory and customer qualification.

What is the financial trajectory for pharmaceutical dextrose monohydrate?

The financial trajectory is stable in volume and cyclical in margin.

Base-case trajectory

Period	Expected commercial pattern
Near term	Stable healthcare demand with input-cost volatility
Medium term	Moderate volume growth from injectables, nutrition and bioprocessing
Longer term	Low-to-moderate growth, with value shifting toward qualified grades

Revenue growth is likely to come from a combination of volume, pharmaceutical-grade mix and regional pricing rather than from major innovation-driven price expansion.

Margin outlook

Margins are strongest when:

• Corn and energy costs are low.
• Plants operate at high utilization.
• Customers purchase qualified grades under multiyear arrangements.
• Suppliers sell directly rather than through commodity channels.
• Injectable and bioprocess volumes increase.
• Freight lanes remain stable.

Margins weaken when:

• Agricultural input costs rise faster than contract prices.
• Energy costs increase.
• Customers resist pass-through pricing.
• Low-cost imports enter a region.
• Plants operate below capacity.
• Buyers qualify multiple suppliers and conduct price tenders.

A supplier with a large pharmaceutical portfolio can absorb volatility better than a business dependent on commodity glucose alone. Pharmaceutical dextrose is strategically useful as part of a broader excipient portfolio, but it is unlikely to be a high-growth product by itself.

What formulations are protected by patents involving dextrose monohydrate?

Dextrose monohydrate itself has no meaningful current composition-of-matter patent barrier. Its use in common tablets, oral liquids, IV solutions and nutritional products is generally based on long-established technology.

Patent protection may apply to:

• A novel combination product.
• A specific injectable formulation.
• A controlled-release dosage form.
• A premixed parenteral nutrition container.
• A proprietary manufacturing process.
• A medical-use claim involving a particular dextrose concentration.
• A delivery device or packaging system.

These patents protect the product or process, not the basic excipient molecule. The relevant claims must be reviewed at the product level.

Are there Orange Book listings for dextrose monohydrate?

The FDA Orange Book primarily identifies patents and regulatory exclusivities associated with approved drug products. Dextrose products may appear as approved drug products, especially injectable solutions, but the presence of dextrose monohydrate as an ingredient does not create an Orange Book patent estate for the excipient.

For a specific dextrose injection, the relevant analysis is:

1. Identify the reference listed drug.
2. Review the product’s Orange Book patent and exclusivity entries.
3. Check whether any listed patent claims the formulation, container, method of use or manufacturing process.
4. Review FDA labeling and approved dosage forms.
5. Assess whether an ANDA applicant could certify under Paragraph IV.

The excipient itself generally does not create a Paragraph IV barrier.

When does dextrose lose exclusivity and what is the generic-entry risk?

Dextrose monohydrate has no practical substance exclusivity period comparable to a new chemical entity. It is a longstanding compound with extensive prior use.

For dextrose-containing drug products, generic-entry risk depends on the finished dosage form:

Product type	Generic-entry risk	Main barrier
Standard oral powder or tablet	High	Low formulation complexity
Basic oral solution	High	Manufacturing and stability controls
Standard dextrose injection	Moderate to high	Sterile manufacturing capacity
High-concentration injection	Moderate	Osmolality, container and manufacturing controls
Premixed nutrition product	Moderate	Container, compatibility and supply complexity
Proprietary combination product	Product-specific	Formulation or method patents

Sterile injectable capacity is the main practical barrier. A competitor may face more difficulty launching an injectable product than an oral dextrose product even when patent protection is limited.

Which companies are challenging dextrose products?

Publicly disclosed Paragraph IV litigation specifically centered on standard dextrose monohydrate products is limited. The competitive threat is more commonly commercial than patent-driven.

Potential challengers include:

• Generic injectable manufacturers.
• Hospital-supply companies.
• Contract manufacturers.
• Regional sterile-product producers.
• Integrated carbohydrate suppliers entering pharmaceutical grades.

The main competitive actions are supplier qualification, tender bidding, manufacturing expansion and alternative sourcing. Litigation becomes more relevant where dextrose is part of a proprietary combination, container system or drug-delivery formulation.

What FDA regulatory status applies to pharmaceutical dextrose?

Dextrose is widely used in FDA-regulated drug products and is also recognized as a pharmaceutical excipient through its inclusion in compendial and regulatory references. FDA’s Inactive Ingredient Database provides information on excipient use in approved drug products, including route and dosage-form context [FDA, 2024a].

Manufacturers must manage:

• Current Good Manufacturing Practice compliance under 21 C.F.R. Parts 210 and 211.
• Pharmacopoeial specifications.
• Identity and assay testing.
• Microbial and endotoxin controls where applicable.
• Elemental impurity risk assessments.
• Supplier qualification.
• Deviation and out-of-specification investigations.
• Change-control notifications.
• Traceability and recall systems.

Injectable manufacturers also assess the material under sterile-drug manufacturing controls and product-specific specifications. A food-grade certificate is not sufficient for pharmaceutical qualification.

How strong is the intellectual-property position for dextrose monohydrate?

The excipient’s direct IP position is weak because the chemical entity and common uses are long established. The defensible commercial assets are operational rather than patent-based.

Asset	Strength
Composition-of-matter patent	Negligible
Basic use patents	Negligible
Manufacturing know-how	Moderate
Crystallization and particle engineering	Moderate
Validated pharmaceutical grades	Strong commercially
Customer-specific qualification	Strong switching barrier
Supply contracts	Moderate
Brand and regulatory documentation	Moderate
Sterile-product formulation patents	Product-specific

Manufacturing know-how may cover crystallization control, impurity removal, particle morphology, drying, packaging and contamination prevention. These advantages may be protected through trade secrets and customer qualification rather than published patents.

What licensing deals affect dextrose monohydrate?

Licensing activity is limited because dextrose is a generic commodity-like excipient. Commercial arrangements are more likely to involve:

• Distribution agreements.
• Regional supply contracts.
• Toll manufacturing.
• Private-label production.
• Technology transfer.
• Strategic sourcing agreements.
• Long-term purchase commitments.

Royalty-bearing licenses are uncommon for standard dextrose monohydrate. They may arise where a supplier licenses a specialized purification process, delivery technology or proprietary combination formulation.

What revenue exposure do pharmaceutical manufacturers have?

Dextrose is strategically important to manufacturers of IV fluids, parenteral nutrition and hospital products, but it is rarely disclosed as a standalone revenue category.

Revenue exposure is highest for companies selling:

• Dextrose injections.
• Premixed parenteral nutrition.
• Hospital fluids.
• Emergency-care products.
• Dialysis and nutrition solutions.
• Contract-manufactured sterile products.

For excipient producers, dextrose revenue is usually part of a broader carbohydrate or pharmaceutical excipient segment. Investors should evaluate:

• Pharmaceutical-grade share of total glucose revenue.
• Exposure to injectable products.
• Geographic concentration.
• Feedstock pass-through mechanisms.
• Plant utilization.
• Customer concentration.
• Recall and compliance history.
• Capacity for low-endotoxin and validated grades.

What geographic markets offer the strongest growth?

North America and Europe provide attractive pricing for qualified pharmaceutical material because of stringent quality requirements and high customer switching costs. Asia-Pacific offers stronger volume growth and expanding pharmaceutical manufacturing capacity.

Region	Commercial characteristics
North America	Stable injectable demand, high compliance requirements, concentrated buyers
Europe	Strong pharmacopoeial requirements, established excipient suppliers
China	Large manufacturing base, competitive costs, growing domestic pharmaceutical demand
India	Expanding generic and injectable production, price-sensitive procurement
Latin America	Import dependence in some markets, regional supply opportunities
Middle East and Africa	Hospital-product demand with greater logistics and supply-continuity sensitivity

Regional qualification matters. A supplier may be technically capable of selling globally but still face separate customer audits, import requirements, pharmacopoeial expectations and regulatory documentation in each market.

What manufacturing and IP barriers affect new entrants?

The principal barriers are qualification and process control, not patents.

A new entrant must establish:

1. Reliable starch feedstock.
2. Hydrolysis and purification capability.
3. Controlled crystallization.
4. Pharmaceutical-grade packaging.
5. Validated analytical methods.
6. GMP-compliant quality systems.
7. Batch traceability.
8. Customer audit readiness.
9. Regulatory change-control procedures.
10. Consistent supply at commercial scale.

Injectable-grade entry is more difficult because customers may require extended qualification, process validation, endotoxin data and multiple successful commercial batches. A low-cost producer can enter oral-grade supply more easily than injectable supply.

Key Takeaways

• Dextrose monohydrate is a mature pharmaceutical excipient and carbohydrate ingredient with stable underlying demand.
• The substance has little direct patent protection; commercial defensibility comes from GMP systems, process know-how and customer qualification.
• Injectable, parenteral nutrition and bioprocess grades generate higher value than standard oral-grade material.
• Feedstock, energy, freight and plant utilization drive short-term margins.
• Public companies generally do not disclose standalone dextrose monohydrate revenue.
• The financial outlook is stable to moderately growing, with limited innovation-driven pricing power.
• Generic-entry risk is high for simple oral products and moderate for sterile injectable products.
• FDA, USP-NF and other pharmacopoeial compliance are central to pharmaceutical sales.
• Regional manufacturing redundancy and validated supply are becoming more valuable than basic production capacity.
• The strongest investment case is a qualified pharmaceutical carbohydrate platform, not dextrose monohydrate as an isolated product.

FAQs

Is dextrose monohydrate the same as glucose monohydrate?

Yes. Dextrose monohydrate is the pharmaceutical term commonly used for crystalline D-glucose containing one molecule of water.

Is dextrose monohydrate interchangeable with anhydrous dextrose?

No. The two materials differ in water content, molecular weight, density and sometimes processing behavior. A formulation change may require recalculation, stability testing and regulatory assessment.

Is pharmaceutical dextrose monohydrate a high-margin product?

It can generate attractive margins in injectable, low-endotoxin and validated grades. Standard oral-grade material is more exposed to commodity pricing and substitution.

Does dextrose monohydrate require a drug master file?

A drug master file may be used where appropriate, but the regulatory strategy depends on the supplier’s role, customer requirements and jurisdiction. Pharmaceutical buyers typically require extensive quality and manufacturing documentation regardless of whether a formal DMF is filed.

Can mannitol or lactose replace dextrose monohydrate?

Sometimes. Replacement depends on dose, route, tonicity, compressibility, hygroscopicity, taste, compatibility and regulatory requirements. Direct substitution is not automatic, particularly in injectable or parenteral nutrition products.

References

1. U.S. Food and Drug Administration. (2024a). Inactive Ingredient Database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

2. U.S. Food and Drug Administration. (2024b). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/

3. U.S. Food and Drug Administration. (2024c). Current good manufacturing practice regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-210

4. U.S. Food and Drug Administration. (2024d). Current good manufacturing practice for finished pharmaceuticals. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211

5. National Library of Medicine. (2024). DailyMed: Dextrose injection labeling. https://dailymed.nlm.nih.gov/dailymed/

6. United States Pharmacopeial Convention. (2024). United States Pharmacopeia and National Formulary, Dextrose monohydrate monograph. Rockville, MD: USP.

7. European Directorate for the Quality of Medicines & HealthCare. (2023). European Pharmacopoeia. Strasbourg, France: Council of Europe.

8. International Council for Harmonisation. (2023). Q7: Good manufacturing practice guide for active pharmaceutical ingredients. https://www.ich.org/page/quality-guidelines