List of Excipients in Branded Drug AUGMENTIN

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Allegis Pharmaceuticals LLC	AUGMENTIN	amoxicillin and clavulanate potassium	28595-240	MANNITOL
Allegis Pharmaceuticals LLC	AUGMENTIN	amoxicillin and clavulanate potassium	28595-240	SACCHARIN SODIUM
Allegis Pharmaceuticals LLC	AUGMENTIN	amoxicillin and clavulanate potassium	28595-240	SILICON DIOXIDE

Generic Drugs Containing AUGMENTIN

Company	Ingredient	NDC	Excipient
Direct_Rx	amox/clav.pot.oral susp	61919-391	ASPARTAME
Direct_Rx	amox/clav.pot.oral susp	61919-391	HYPROMELLOSE 2910
Direct_Rx	amox/clav.pot.oral susp	61919-391	SILICON DIOXIDE

What are the Most Frequently-Used Excipients in AUGMENTIN?

# Of NDCs	Excipient
1	ASPARTAME
1	HYPROMELLOSE 2910
1	SILICON DIOXIDE

AUGMENTIN Excipient Strategy and Commercial Opportunities

Last updated: August 7, 2026

Augmentin is the fixed-dose combination of amoxicillin and clavulanate potassium. Its commercial value is driven less by active-ingredient differentiation than by formulation performance: clavulanate stability, moisture control, pediatric palatability, dosing flexibility, and reliable dispersion. The strongest excipient opportunities are in oral suspensions, high-dose pediatric products, modified tablets, sachets, and manufacturing systems that reduce degradation and improve global supply economics.

What is Augmentin and which formulations are commercially relevant?

Augmentin combines the beta-lactam antibiotic amoxicillin with clavulanate, a beta-lactamase inhibitor. The combination expands amoxicillin activity against beta-lactamase-producing organisms. GlaxoSmithKline developed and commercialized the product, which is now available through branded, authorized-generic, and generic products in multiple countries.

The principal dosage forms are:

Dosage form	Typical commercial use	Key formulation issue
Immediate-release tablets	Adults and older children	Moisture sensitivity, dose proportionality, swallowability
Chewable tablets	Pediatric patients	Taste masking, friability, dose uniformity
Oral powder for suspension	Infants and children	Palatability, reconstitution, sedimentation, short in-use stability
High-strength pediatric suspension	Children requiring higher clavulanate and amoxicillin doses	Dose volume, gastrointestinal tolerability, powder flow
Sachets or unit-dose powders	Selected international markets	Moisture protection, reconstitution and portability
Intravenous amoxicillin/clavulanate products	Hospital use in some markets	Sterility, reconstitution, compatibility and separate regulatory controls

The most commercially attractive excipient segment is pediatric oral suspension. Pediatric formulations require a combination of taste masking, rapid redispersion, low sedimentation, preservative control, and packaging that limits moisture ingress.

What excipients are used in Augmentin tablets and suspensions?

Commercial Augmentin labels identify different inactive ingredients by strength, dosage form and market. The exact composition is not uniform across all products. FDA labeling and DailyMed listings should be used for product-specific verification.[1,2]

Tablet excipients

Immediate-release Augmentin tablets commonly use excipients from the following categories:

• Microcrystalline cellulose as a diluent and compression aid
• Sodium starch glycolate or another disintegrant
• Colloidal silicon dioxide as a glidant
• Magnesium stearate as a lubricant
• Hypromellose and related polymers in film coating
• Titanium dioxide, talc or other coating components, depending on the market and strength
• Opacifiers, colorants and polishing agents in the film coating

The commercial formulation objective is rapid disintegration without excessive moisture exposure. Amoxicillin and clavulanate are both vulnerable to formulation and storage conditions, but clavulanate is generally the more demanding component from a stability perspective.

Chewable-tablet excipients

Chewable products require:

• Compressible fillers
• Sweeteners
• Flavors
• Lubricants
• Disintegrants
• Taste-masking polymers or coating systems

The main development constraint is the unpleasant taste associated with beta-lactam antibiotics and clavulanate. A formulation that meets dissolution requirements but produces a strong aftertaste can fail commercially in pediatric use.

Powder-for-suspension excipients

Oral suspension formulations commonly use:

• Sucrose or other bulk sweeteners
• Xanthan gum or another suspending agent
• Colloidal silicon dioxide
• Flavoring systems
• Sweeteners such as aspartame in some products
• Buffering or pH-control components
• Preservatives where required by the formulation and jurisdiction

Augmentin ES-600 labeling identifies inactive ingredients including xanthan gum, colloidal silicon dioxide, flavoring components, sweeteners and other formulation aids. Product-specific labels must be checked because excipient compositions vary by strength and market.[1]

The suspension must redisperse rapidly after storage, remain dose-uniform throughout the dosing interval, and maintain acceptable potency after reconstitution. Excessive viscosity can impair dosing and create bottle-retention losses. Low viscosity can produce rapid sedimentation and inaccurate dosing.

Which excipient properties control Augmentin product performance?

Clavulanate stability

Clavulanate is sensitive to moisture, temperature and formulation conditions. Excipient selection affects water activity, microenvironmental pH, solid-state behavior and degradation kinetics. A low-moisture manufacturing process, high-barrier packaging and controlled storage conditions can be as important as the excipient identity itself.

Commercial development should evaluate:

• Residual moisture in active ingredients and excipients
• Water activity after blending and compression
• Hygroscopicity of diluents and disintegrants
• Microenvironmental pH
• Interaction between clavulanate and reducing or reactive excipients
• Packaging moisture transmission rate
• Stability after suspension reconstitution

Dose uniformity

Amoxicillin and clavulanate have different physicochemical properties and are present at different ratios across products. Segregation risk can arise during blending, transfer and filling. Particle-size matching, engineered granules and direct-compression platforms can reduce content-uniformity risk.

For powder suspensions, the active ingredients must remain evenly distributed in the bottle before and after reconstitution. Suspending agents, wetting behavior and particle-size distribution determine whether the patient receives the intended ratio at each dose.

Palatability

Taste masking is a primary commercial differentiator. The most practical approaches include:

1. Polymeric coating of drug particles.
2. Ion-exchange or complexation systems where compatible with release and stability requirements.
3. Flavor and sweetener optimization.
4. Viscosity control to limit contact with taste receptors.
5. Multiparticulate or granulated delivery systems.

Taste masking must not compromise reconstitution, dissolution, dose uniformity or clavulanate stability. Strong flavor systems can also create regulatory and acceptability problems when used across multiple age groups.

Suspending performance

Xanthan gum is widely used because it provides suspension structure at relatively low concentration. Commercial optimization requires control of:

• Yield stress
• Sedimentation rate
• Redispersion time
• Pourability
• Syringeability
• Bottle residue
• Dose-volume accuracy

A high-yield-stress system may remain uniform but become difficult to pour or draw into an oral syringe. A low-yield-stress system may be easy to administer but settle rapidly.

What formulation patents protect Augmentin products?

The core composition and original product patents for amoxicillin/clavulanate have expired in major markets. Commercial exclusivity now depends primarily on regulatory status, trademarks, manufacturing know-how, product-specific formulations and, in some jurisdictions, later patents covering particular dosage forms, ratios, processes or uses.

The original Augmentin franchise included multiple strengths and formulations. Later product development included high-dose pediatric suspensions and other dosage variants. Any current freedom-to-operate analysis must distinguish:

• Expired composition patents
• Active formulation patents, if any
• Process patents
• Packaging or delivery-device rights
• Method-of-use patents
• Regulatory exclusivity
• Trademark rights for the Augmentin name

What is the Orange Book status of Augmentin?

FDA-approved Augmentin products are associated with approved new drug applications and generic abbreviated new drug applications. The FDA Orange Book identifies listed patents and exclusivity associated with approved products, but the status can differ by strength, dosage form and NDA reference.[3]

A generic applicant may pursue:

• Paragraph I certification where no patent information is listed
• Paragraph II certification where listed patents have expired
• Paragraph III certification with a proposed post-expiration launch
• Paragraph IV certification alleging that listed patents are invalid, unenforceable or not infringed

Because the original product has been marketed for decades, the principal competitive barriers are generally formulation execution, manufacturing economics, regulatory approval and distribution rather than a single foundational composition patent.

When did Augmentin lose exclusivity and what generic entry risks remain?

The core commercial exclusivity period ended long ago, and generic amoxicillin/clavulanate products are widely marketed. The principal remaining entry risks are product-specific.

Generic entry risks

A generic manufacturer must manage:

• Bioequivalence for the relevant dosage form
• Dose proportionality across strengths
• Clavulanate assay and degradation products
• Suspension redispersion and dose uniformity
• Pediatric palatability
• Container-closure performance
• Stability after reconstitution
• Manufacturing capacity for both active ingredients
• Antibiotic quality-system requirements

For immediate-release tablets, the technical barrier is moderate. For pediatric suspension, the barrier is higher because a successful product must meet physical, chemical and user-performance requirements simultaneously.

Paragraph IV litigation

Paragraph IV litigation risk depends on the existence of unexpired Orange Book-listed patents for the specific reference product. The original Augmentin products are not generally viewed as protected by a broad, unexpired composition patent. A current launch assessment must review the FDA Orange Book at the time of filing and identify any later-listed patents covering a particular strength, formulation or delivery system.[3]

Litigation exposure can also arise from:

• Patent infringement claims against formulation processes
• Trade-secret disputes involving granulation or coating technology
• Trademark disputes over product naming
• Antitrust or competition claims involving authorized generics
• Regulatory disputes over substitutability or labeling

How can excipient suppliers create commercial opportunities around Augmentin?

Pediatric taste-masking systems

The highest-value opportunity is a turnkey taste-masking platform for amoxicillin/clavulanate powder or granules. Suppliers can offer coated API particles, taste-masked granules or multiparticulates with documented dissolution and stability performance.

A commercially useful platform should demonstrate:

• Reduced bitterness in validated sensory testing
• No adverse effect on clavulanate recovery
• Rapid release in simulated gastrointestinal conditions
• Low moisture uptake
• Compatibility with standard suspension excipients
• Scale-up from laboratory to commercial granulation

Low-moisture excipient systems

Excipient suppliers can differentiate through low-water-content grades of:

• Microcrystalline cellulose
• Silicified microcrystalline cellulose
• Colloidal silicon dioxide
• Spray-dried sweeteners
• Direct-compression diluents
• Co-processed excipient systems

The value proposition is reduced degradation and improved tablet robustness without adding complex manufacturing steps.

High-performance suspending agents

A tailored suspending-agent package can combine xanthan gum with wetting, buffering and flow-control components. The commercial target is a formulation that delivers rapid redispersion, low bottle retention and accurate oral-syringe dosing.

Premium packaging

High-barrier bottles, induction seals, desiccant systems and unit-dose sachets can protect clavulanate-containing products in humid climates. Packaging suppliers can compete through moisture transmission data, child-resistant designs and compatibility with reconstituted suspensions.

Excipient-enabled line extensions

Potential line extensions include:

• Smaller-volume pediatric suspensions with higher drug concentration
• Ready-to-use suspensions, where stability is achievable
• Unit-dose sachets
• Oral-syringe-compatible bottles
• Sugar-free formulations
• Allergen-conscious or colorant-free variants
• Taste-masked granules for flexible dosing
• Hospital-oriented reconstitution formats

Each line extension requires product-specific stability, bioequivalence or comparative-performance data. A formulation change cannot assume automatic regulatory interchangeability merely because the active ingredients and strengths are unchanged.

Which Augmentin competitors have the strongest commercial position?

The market includes the branded Augmentin franchise, authorized generics and independent generic amoxicillin/clavulanate products. Competition is based on price, supply reliability, pharmacy substitution, pediatric acceptance and hospital contracting.

Competitive segment	Main advantage	Main weakness
Branded Augmentin	Prescriber recognition and established labeling	Higher price and limited differentiation
Authorized generic	Brand-linked manufacturing and broad distribution	Lower brand visibility
Large generic manufacturers	Price, scale and pharmacy access	Potentially limited formulation differentiation
Regional manufacturers	Local pricing and regulatory access	Smaller supply networks
Specialty pediatric suppliers	Taste and delivery innovation	Higher development and manufacturing cost

The strongest commercial position is likely to come from a supplier that combines low-cost active procurement with superior suspension performance and reliable supply in high-demand pediatric markets.

What manufacturing and intellectual-property barriers affect Augmentin opportunities?

Manufacturing barriers are more important than foundational patent barriers. Amoxicillin and clavulanate require controlled handling, validated analytical methods and tight stability programs. The formulation must also address cross-contamination controls, blend uniformity and moisture management.

Key manufacturing risks include:

• Clavulanate degradation during wet granulation
• Segregation between active ingredients and excipients
• Over-lubrication and delayed tablet disintegration
• Inadequate powder flow during bottle filling
• Inconsistent suspension viscosity
• Inaccurate reconstitution volume
• Packaging failure under high humidity
• Short post-reconstitution shelf life

Intellectual-property value may reside in proprietary coating processes, polymer combinations, granulation parameters, packaging configurations and analytical methods rather than in the general use of conventional excipients.

What is the FDA regulatory status of Augmentin formulations?

Augmentin is an FDA-approved prescription antibacterial product. FDA labeling covers tablets, chewable tablets and oral suspensions, with strength-specific administration, storage and reconstitution instructions.[1,2]

Regulatory review focuses on:

• Identity and strength of both active ingredients
• Assay and impurity profiles
• Dissolution and drug release
• Content uniformity
• Bioequivalence where applicable
• Microbial quality
• Preservative effectiveness when preservatives are used
• Reconstituted-product stability
• Container-closure integrity
• Labeling of excipients and storage conditions

Pediatric products require careful attention to sweeteners, flavoring agents, colorants and potential excipient exposure. Aspartame-containing products may require jurisdiction-specific labeling because of phenylalanine considerations.

How strong is the Augmentin patent estate?

The original Augmentin patent estate is commercially mature. Foundational exclusivity has expired in the principal markets, and generic competition is established. The remaining estate should be assessed at the product level rather than at the molecule level.

Patent or protection category	Current strategic relevance
Original amoxicillin/clavulanate composition claims	Low, generally expired
Product-specific formulation claims	Potentially relevant if unexpired
Manufacturing-process claims	Relevant where process is difficult to design around
Pediatric suspension claims	Potentially relevant for later formulations
Method-of-use claims	Usually limited commercial value for a mature antibiotic
Trademarks and trade dress	Relevant to branded products
Regulatory exclusivity	Generally limited for long-established products

Patent strength is therefore moderate to low for blocking generic entry at the platform level, but it can be higher for a narrowly claimed taste-masking, stability or delivery system.

What revenue exposure and launch scenarios matter for investors?

Augmentin is a mature, high-volume antibiotic franchise. Revenue exposure is concentrated in:

• Pediatric respiratory and ear infections
• Primary-care prescribing
• Seasonal demand
• Hospital and outpatient channels
• International markets with varying generic substitution rules

Likely launch scenarios

A new entrant could pursue one of four commercial strategies:

1. Low-cost conventional tablets, competing on price and supply.
2. Pediatric suspension, competing on taste, dosing convenience and stability.
3. Authorized-generic or branded-generic positioning through a regional partner.
4. Excipient-enabled reformulation, targeting improved adherence or reduced dosing volume.

The conventional tablet segment has lower technical risk but greater price pressure. Pediatric suspension has better differentiation potential but requires stronger formulation evidence and more complex manufacturing controls.

Key Takeaways

• Augmentin is an amoxicillin/clavulanate product whose main formulation challenge is clavulanate stability.
• Pediatric oral suspension is the strongest excipient-driven opportunity.
• Taste masking, low-moisture excipients, suspending systems and high-barrier packaging offer the clearest differentiation.
• The original composition patent estate is mature, with generic competition established in major markets.
• Current patent risk must be reviewed by strength, dosage form, NDA and jurisdiction.
• Manufacturing know-how and regulatory execution are more important barriers than foundational molecule patents.
• Tablet entry is commercially accessible but price competitive.
• Pediatric and high-strength suspension products offer greater margin and differentiation potential.
• Commercial success depends on dose uniformity, reconstitution performance, palatability, stability and supply reliability.

FAQs

Can a new excipient combination receive patent protection for an Augmentin generic?

Yes. Protection may be available for a non-obvious excipient combination, taste-masking architecture, stability improvement, granulation process or delivery format. The claims must be novel, non-obvious and adequately supported.

Which excipient is most important for Augmentin suspension performance?

The suspending-agent system is central, but performance depends on the combined effect of xanthan gum, wetting agents, sweeteners, particle size, viscosity and packaging. No single excipient determines overall product quality.

Is a sugar-free Augmentin suspension commercially attractive?

Yes, particularly in pediatric and diabetic-care segments. The formulation must preserve palatability, suspension stability, dose uniformity and acceptable preservative performance after sucrose removal.

Can a ready-to-use Augmentin suspension replace powder for reconstitution?

Only if the product can maintain acceptable amoxicillin and clavulanate stability throughout its labeled shelf life. A ready-to-use product faces substantially higher water-driven degradation risk than a dry powder.

Are formulation excipient suppliers exposed to antibiotic price erosion?

Yes. Conventional excipients face commodity pricing pressure. Suppliers with validated taste masking, moisture-control, pediatric dosing or high-performance suspension platforms have stronger prospects for retaining margin.

References

1. U.S. Food and Drug Administration. (2024). Augmentin (amoxicillin and clavulanate potassium) prescribing information.
2. National Library of Medicine. (2024). DailyMed: Augmentin and Augmentin ES-600 product labeling.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book.
4. European Medicines Agency. (2024). Co-amoxiclav product information and excipient labeling.
5. World Health Organization. (2023). WHO guideline on stability evaluation of pharmaceutical products containing well-established active pharmaceutical ingredients.