List of Excipients in Branded Drug CEFACLOR

Generic Drugs Containing CEFACLOR

Company	Ingredient	NDC	Excipient
Teva Pharmaceuticals USA Inc	cefaclor	0093-1087	ALUMINUM OXIDE
Teva Pharmaceuticals USA Inc	cefaclor	0093-1087	FD&C BLUE NO. 2
Teva Pharmaceuticals USA Inc	cefaclor	0093-1087	HYPROMELLOSE 2208

What are the Most Frequently-Used Excipients in CEFACLOR?

# Of NDCs	Excipient
3	ALCOHOL
1	ALUMINUM OXIDE
3	AMMONIA

Last updated: August 9, 2026

Cefaclor is a mature, off-patent oral cephalosporin with limited opportunity in conventional immediate-release capsules and suspensions. The strongest commercial opportunities are differentiated pediatric liquids, moisture-controlled solid doses, unit-dose packaging, taste-masked suspensions, and reliable supply for markets where first-generation and newer oral cephalosporins are constrained. The core active-ingredient patent estate no longer provides a meaningful barrier; competitive advantage must come from formulation performance, manufacturing reliability, regulatory execution, and market access.

Cefaclor Excipient Strategy and Commercial Opportunities

What is the current commercial and regulatory position of cefaclor?

Cefaclor is an orally administered second-generation cephalosporin marketed as cefaclor monohydrate. Approved dosage forms have included immediate-release capsules, oral suspension, and modified-release products. The drug is used for susceptible bacterial infections, including respiratory tract, skin and skin-structure, urinary tract, and otitis media indications, subject to applicable labeling and antimicrobial stewardship requirements.[1][2]

Attribute	Cefaclor profile
Active ingredient	Cefaclor monohydrate
Drug class	Oral second-generation cephalosporin
Common strengths	125 mg/5 mL, 187.5 mg/5 mL, 250 mg/5 mL suspension; 250 mg and 500 mg capsules
Key dosage forms	Immediate-release capsules and powders for oral suspension
Pediatric relevance	High, particularly for otitis media and respiratory infections
Route	Oral
FDA pathway	NDA-originated product with generic ANDA competition
Biosimilar exposure	None; cefaclor is a small-molecule drug
Core patent position	Mature and generally off-patent
Main commercial barriers	Formulation stability, taste, reconstitution performance, supply, bioequivalence, and manufacturing controls

Cefaclor is not a biologic and does not face biosimilar competition. Generic applicants generally compete through abbreviated new drug applications rather than the biosimilar pathway. FDA approval depends on pharmaceutical equivalence, bioequivalence, quality, labeling, and manufacturing compliance.[3]

The commercial market is therefore driven by generic economics. A differentiated product must offer a measurable advantage over established cefaclor capsules or suspension products.

What excipients are used in cefaclor formulations?

The excipient system depends on the dosage form. Capsules require protection against moisture and physical degradation. Powders for oral suspension require a dry blend that maintains potency during storage, disperses rapidly after reconstitution, controls microbial growth, and masks the drug’s taste.

Immediate-release capsules

Cefaclor capsules typically use a hard-gelatin shell and a powder or granulated fill. Relevant excipient functions include:

Function	Potential excipient classes	Commercial purpose
Dilution	Lactose, microcrystalline cellulose, starches, mannitol	Controls fill weight and content uniformity
Granulation	Povidone, copovidone, pregelatinized starch	Improves flow and dose uniformity
Disintegration	Croscarmellose sodium, crospovidone, sodium starch glycolate	Supports rapid drug release
Lubrication	Magnesium stearate, sodium stearyl fumarate	Supports capsule filling and ejection
Flow control	Colloidal silicon dioxide	Reduces segregation and improves powder flow
Moisture control	Low-moisture excipients, desiccant packaging, high-barrier bottles	Protects cefaclor potency and physical quality
Appearance	Titanium dioxide, iron oxides, colorants	Product identification and market differentiation

Cefaclor is a beta-lactam antibiotic. Beta-lactam structures can be vulnerable to hydrolytic degradation, making water activity, residual moisture, packaging, and processing temperature important development variables. Excessive use of hygroscopic excipients can create stability problems even when the final capsule passes initial release testing.

A low-moisture direct-blend approach may reduce processing exposure, but it can create segregation risk if cefaclor particle size and excipient density differ materially. Roller compaction or dry granulation can improve flow without introducing water, but compression and compaction conditions must be controlled to avoid poor dissolution.

Powders for oral suspension

Cefaclor oral suspension presents the largest excipient opportunity because the formulation must address several competing requirements:

• rapid wetting and dispersion;
• sedimentation control;
• redispersibility after storage;
• acceptable viscosity;
• microbial protection after reconstitution;
• chemical stability;
• pediatric taste masking;
• accurate dose delivery.

A typical functional architecture may include:

Formulation need	Candidate excipient approach
Bulking and mouthfeel	Sucrose, mannitol, sorbitol, or other polyols
Suspending system	Xanthan gum, sodium carboxymethylcellulose, microcrystalline cellulose with sodium carboxymethylcellulose
Wetting	Polysorbate or another low-level surfactant, subject to compatibility
Buffering	Citrate, phosphate, or other buffer system selected through stability studies
Sweetening	Sucrose, sucralose, acesulfame potassium, or combinations
Flavor	Fruit flavors, often selected for compatibility with antibiotic bitterness
Preservative	Sodium benzoate, potassium sorbate, or another permitted antimicrobial preservative
Anticaking and flow	Colloidal silicon dioxide or equivalent processing aid
Color	Approved colorant for product identification

The final excipient composition must be established through formulation development and regulatory review. A candidate excipient is not commercially useful merely because it is pharmaceutically common. It must work at the required concentration, remain compatible with cefaclor, support acceptable dosing accuracy, and fit the target market’s regulatory requirements.

What are the main formulation risks for cefaclor?

How important is moisture control?

Moisture control is a primary development issue for cefaclor. Risk points include:

1. powder manufacture;
2. bulk storage;
3. capsule filling;
4. bottle opening and closing;
5. reconstitution of suspension;
6. repeated administration from a multidose bottle.

For capsules, high-barrier packaging may be more valuable than a complex excipient system. A polyethylene bottle with a desiccant may provide a practical balance between cost and protection. Blister packaging can improve unit-dose protection but may increase packaging cost and complicate pediatric or institutional use.

For suspensions, the product must be designed around the in-use period after reconstitution. The label may require storage under specified conditions and discarding after a defined period. The commercial value of a formulation that extends in-use stability depends on whether it reduces waste, improves pharmacy handling, or permits broader distribution.

How should cefaclor taste be masked?

Cefaclor suspension is intended for pediatric use, making taste a commercial differentiator. Taste masking can use:

• high-solids sweetener systems;
• fruit flavor combinations;
• polymeric coating of drug particles;
• ion-exchange resin complexes;
• lipid or wax barriers;
• pH-mediated reduction of perceived bitterness;
• multiparticulate or microencapsulated drug technology.

The most practical strategy is often a coordinated system combining particle engineering, sweeteners, flavor, and viscosity control. A coating that delays wetting may improve taste but reduce dissolution or create dose nonuniformity. Resin complexation can improve palatability but adds process complexity and may affect release, assay, and bioequivalence.

Taste masking should be tested with age-appropriate sensory methods rather than adult-only panels. Pediatric acceptability can influence adherence, refill behavior, and prescribing preference, particularly where multiple oral antibiotic options are available.

What suspension properties are commercially valuable?

A differentiated cefaclor suspension should be evaluated for:

• reconstitution time;
• powder wetting;
• sedimentation rate;
• redispersibility after standing;
• viscosity at refrigerated and room temperatures;
• dose-volume accuracy;
• syringe compatibility;
• bottle-wall adhesion;
• foaming;
• flavor persistence;
• in-use chemical stability;
• preservative effectiveness.

A suspension that requires vigorous shaking, forms a hard sediment, or clogs an oral syringe creates avoidable pharmacy and caregiver problems. Excipient selection should therefore be linked to the intended delivery device. A formulation optimized for a measuring spoon may perform poorly through a low-volume oral syringe.

What formulations are protected by cefaclor patents?

The original cefaclor composition-of-matter and product patent protection is no longer the principal commercial barrier in the United States. Cefaclor has been marketed for decades, and generic products have been approved through the ANDA pathway.

The remaining intellectual-property opportunity is more likely to arise from:

• specific taste-masking systems;
• controlled-release or modified-release matrices;
• particle-size distributions;
• coated cefaclor particles;
• stable dry-suspension compositions;
• preservative systems;
• moisture-resistant packaging combinations;
• manufacturing processes;
• device-linked dosing systems;
• selected methods of use in defined populations.

These rights would need to satisfy novelty, non-obviousness, enablement, written description, and infringement requirements. A formulation patent that merely substitutes one conventional sweetener, suspending agent, or flavor for another is vulnerable unless it demonstrates an unexpected technical result.

Patent applicants should generate comparative data against marketed cefaclor products. Useful evidence includes:

• potency after accelerated and long-term storage;
• degradation-product reduction;
• dissolution or release performance;
• taste-panel scores;
• reconstitution time;
• sedimentation and redispersibility;
• preservative effectiveness;
• dose-delivery accuracy;
• reduced excipient load;
• improved stability after bottle opening.

When does cefaclor lose exclusivity, and are Paragraph IV challenges relevant?

Cefaclor’s original market exclusivity and basic patent protection have expired. Paragraph IV litigation is therefore most relevant to later-issued formulation, manufacturing, or modified-release patents, not to ordinary cefaclor capsules or conventional immediate-release suspensions.

Exclusivity issue	Practical assessment
New chemical entity exclusivity	Expired
Basic composition patent	Expired or commercially immaterial
Conventional capsule protection	No meaningful patent barrier expected
Conventional suspension protection	No meaningful patent barrier expected
Modified-release protection	Relevant only if a live patent remains listed or otherwise enforceable
Formulation patent risk	Product-specific and claim-dependent
Paragraph IV exposure	Possible for listed patents tied to a specific reference product
180-day generic exclusivity	Relevant only to qualifying ANDA applicants and applicable listings
Biosimilar exclusivity	Not applicable

The FDA Orange Book should be reviewed for the specific reference-listed drug and dosage form before a launch decision. Patent listings can differ between immediate-release and modified-release products, and discontinued products may remain relevant to historical regulatory analysis even when commercial availability changes.[3]

What is the Orange Book status of cefaclor?

The Orange Book identifies reference-listed drugs, approved generic equivalents, patent information, and exclusivity data. Cefaclor products should be analyzed by dosage form and strength rather than as a single product family.

For a proposed generic or reformulated product, the key Orange Book questions are:

1. Is the target product currently listed as a reference product?
2. Are patents listed for the specific strength and dosage form?
3. Is the product eligible for an ANDA or does the formulation require a different FDA pathway?
4. Does the proposed product have the same active ingredient, dosage form, route, strength, and labeling basis?
5. Are any listed patents directed to release characteristics or formulation limitations?

An ordinary cefaclor capsule or suspension generally has a more straightforward ANDA strategy than a taste-masked, microencapsulated, or modified-release product. A genuinely different release profile may require a separate clinical and regulatory strategy rather than a simple generic filing.

What commercial opportunities exist for cefaclor excipients and formulations?

Pediatric ready-to-use and low-waste suspension

A ready-to-use suspension could reduce pharmacy reconstitution steps and caregiver error. The commercial tradeoff is higher shipping weight, greater packaging volume, and potentially shorter shelf life. It is most attractive in institutional, hospital-discharge, and pediatric specialty channels.

A concentrated suspension could reduce bottle size but would require careful dosing-device design. Small volume errors can produce clinically meaningful dose deviations in children.

Improved taste-masked dry suspension

A dry suspension with improved palatability, rapid reconstitution, and stable in-use performance has the clearest product-differentiation potential. The opportunity is strongest where cefaclor remains clinically preferred or where local supply of other pediatric oral antibiotics is inconsistent.

Unit-dose and institutional packaging

Unit-dose bottles, sachets, or blister-based powder systems may support hospitals, outpatient clinics, correctional facilities, and public-sector procurement. Packaging can reduce dispensing errors and improve inventory control. The economic case depends on procurement specifications and packaging-line cost.

Moisture-protected capsules

A capsule product with high-barrier unit-dose packaging, low extractables, and demonstrated stability in hot and humid climates may compete in emerging markets. Geographic value is greatest where warehouse conditions are poor and distribution chains lack environmental control.

Excipient-simplified products

A lower-excipient formulation may support markets with restrictions on sucrose, certain dyes, or specific preservatives. This approach can appeal to pediatric, diabetic, dental-health, and institutional segments. It must not compromise taste, stability, or suspension performance.

Contract development and manufacturing

Cefaclor offers opportunities for contract manufacturers with:

• dry-granulation capability;
• pediatric suspension technology;
• spray coating or microencapsulation;
• high-barrier packaging;
• regional regulatory registrations;
• validated antimicrobial-preservative systems;
• flexible small-batch production.

The asset is more attractive as a platform for formulation and supply services than as a high-margin branded generic.

How does cefaclor compare with competing oral antibiotics?

Product	Commercial position	Excipient opportunity	Competitive constraint
Cefaclor	Mature oral cephalosporin	Pediatric taste masking, suspension stability, supply	Generic price pressure
Cephalexin	Broad generic use and strong physician familiarity	Pediatric liquids and concentrated suspensions	Greater generic competition
Cefuroxime axetil	Second-generation cephalosporin with formulation complexity	Taste masking and particle engineering	More difficult palatability and bioavailability control
Amoxicillin/clavulanate	High pediatric demand	Suspension stability and dosing convenience	Strong guideline and prescribing presence
Cefdinir	Pediatric oral cephalosporin	Flavor, color, and suspension performance	Established branded-generic competition
Azithromycin	Broad outpatient use	Powder-for-suspension and taste systems	Different class and dosing profile

Cefaclor’s best commercial position is not broad therapeutic substitution. It is a targeted product offering improved administration, dependable supply, or regional availability.

What generic launch risks exist for cefaclor?

The principal launch risks are commercial and operational rather than foundational patent risks.

Risk	Impact
Low reimbursement price	Limits return on formulation investment
Small or declining demand	Increases inventory and registration risk
Pediatric taste failure	Can reduce prescribing and adherence
Suspension instability	Creates recalls, waste, or pharmacy complaints
Inadequate moisture protection	Causes potency or dissolution failures
Bioequivalence complexity	Delays approval for modified formulations
Excipient supply disruption	Interrupts production
Preservative failure	Creates microbiological quality risk
Device incompatibility	Produces inaccurate dosing
Regional regulatory divergence	Increases development and registration cost

For a standard capsule, launch economics favor low-cost manufacturing and reliable supply. For a differentiated suspension, the business case depends on proving that the formulation solves a specific customer problem and supports pricing above commodity generic levels.

Which companies are challenging cefaclor exclusivity?

The cefaclor market is characterized by generic competition rather than a current high-profile patent challenge. Multiple manufacturers have historically supplied cefaclor products through ANDA approvals, subject to market availability and FDA manufacturing status.

Company-specific launch and litigation conclusions should be based on current FDA ANDA records, Orange Book entries, court dockets, and commercial shipment data. A generic approval alone does not establish active commercial supply. The relevant competitive set should separate:

• approved but inactive applicants;
• marketed generic suppliers;
• authorized distributors;
• contract manufacturers;
• discontinued or supply-constrained products.

How strong is the cefaclor patent estate?

The patent estate is weak for conventional cefaclor products and potentially moderate for narrowly defined reformulations.

Estate component	Strength assessment
Original cefaclor molecule	Expired
Standard capsule	Low
Conventional suspension	Low
Taste-masked suspension	Potentially moderate if supported by comparative data
Modified release	Product- and claim-specific
Packaging-only claims	Usually limited unless tied to a technical stability result
Manufacturing process	Potentially useful but often design-aroundable
Device-linked delivery	Moderate if claims cover a specific integrated system
Geographic protection	Patent rights are jurisdiction-specific

The most defensible strategy is a layered portfolio combining formulation claims, process claims, stability data, and device or packaging claims. The claims should focus on measurable performance rather than an open-ended list of conventional excipients.

What regulatory strategy is appropriate for a cefaclor reformulation?

A standard immediate-release generic capsule or suspension generally fits the ANDA route when it matches the reference product in active ingredient, dosage form, strength, route, and performance requirements.[3]

A reformulation may require greater regulatory work where it changes:

• release rate;
• dosing frequency;
• concentration;
• reconstitution characteristics;
• delivery device;
• excipient exposure;
• labeling;
• pediatric use instructions.

FDA guidance and relevant compendial standards should guide dissolution, assay, impurities, content uniformity, microbial quality, and stability programs.[4][5] Antibiotic powders for suspension also require appropriate microbiological controls and preservative-effectiveness testing where preservatives are used.

Key Takeaways

• Cefaclor is a mature, generic oral cephalosporin with no meaningful basic patent moat.
• Immediate-release capsules are primarily a cost, supply, and packaging business.
• Pediatric oral suspension offers the strongest formulation-differentiation opportunity.
• The highest-value excipient work concerns taste masking, redispersibility, moisture protection, preservative performance, and dose accuracy.
• Modified-release and microencapsulated products may support stronger intellectual-property positions but carry greater bioequivalence and development risk.
• A formulation patent should be supported by comparative stability, palatability, dissolution, or dosing data.
• Cefaclor has no biosimilar risk because it is a small-molecule antibiotic.
• Orange Book, FDA ANDA, and current commercial-supply records should be reviewed by strength and dosage form.
• Geographic opportunities are strongest in markets with pediatric antibiotic demand, weak cold-chain or warehouse control, and inconsistent generic supply.
• The best business model is a differentiated generic or contract-development platform, not a conventional commodity capsule.

FAQs

Can cefaclor be formulated without sucrose?

Yes. Polyols, mannitol, selected polymers, and high-intensity sweeteners can replace sucrose, but the formulation must be reoptimized for viscosity, taste, sedimentation, microbial protection, and dose accuracy.

Is cefaclor suitable for an extended-release tablet?

The molecule can be incorporated into modified-release systems, but the product would require dedicated release, bioequivalence, stability, and regulatory development. It should not be treated as a routine immediate-release ANDA substitution.

Which packaging is best for cefaclor capsules?

High-barrier bottles with desiccant protection are a practical option. Unit-dose blister packaging may provide stronger moisture protection but generally costs more and can reduce packaging-line flexibility.

Can a cefaclor suspension be sold as a ready-to-use liquid?

Yes, but the product would need a new formulation and stability program. Shipping weight, microbial control, in-use stability, and packaging cost become more important than in a powder-for-reconstitution product.

Does cefaclor have biosimilar competition?

No. Cefaclor is a chemically synthesized small molecule. Competitive products are generics approved through the ANDA pathway, not biosimilars.

References

1. U.S. Food and Drug Administration. (n.d.). Cefaclor prescribing information. FDA labeling database.

2. DailyMed. (n.d.). Cefaclor: Product labeling and inactive ingredients. National Library of Medicine.

3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. Orange Book.

4. United States Pharmacopeia. (2024). United States Pharmacopeia and National Formulary. U.S. Pharmacopeial Convention.

5. International Council for Harmonisation. (2003). Q1A(R2): Stability testing of new drug substances and products. ICH.

6. World Health Organization. (2022). WHO guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products. World Health Organization.