List of Excipients in Branded Drug CEFDINIR

« Back to Dashboard

Generic Drugs Containing CEFDINIR

Company	Ingredient	NDC	Excipient
Teva Pharmaceuticals USA Inc	cefdinir	0093-3160	CARBOXYMETHYLCELLULOSE CALCIUM
Teva Pharmaceuticals USA Inc	cefdinir	0093-3160	CROSCARMELLOSE SODIUM
Teva Pharmaceuticals USA Inc	cefdinir	0093-3160	D&C RED NO. 28
Teva Pharmaceuticals USA Inc	cefdinir	0093-3160	D&C YELLOW NO. 10
Teva Pharmaceuticals USA Inc	cefdinir	0093-3160	D&C YELLOW NO. 10 ALUMINUM LAKE
Teva Pharmaceuticals USA Inc	cefdinir	0093-3160	FD&C BLUE NO. 1

What are the Most Frequently-Used Excipients in CEFDINIR?

# Of NDCs	Excipient
1	ALCOHOL
3	ALUMINUM OXIDE
6	AMMONIA
55	ANHYDROUS CITRIC ACID
20	ANHYDROUS TRISODIUM CITRATE
1	BUTYL ALCOHOL

Cefdinir Excipient Strategy and Commercial Opportunities in Capsules and Oral Suspension

Last updated: October 9, 2026

Cefdinir is a generic, orally administered third-generation cephalosporin with commercial opportunities centered on pediatric suspension, taste masking, iron-compatibility management, differentiated packaging, and reliable global supply. The core active ingredient is off-patent, so formulation execution and manufacturing economics matter more than molecule-level exclusivity.

Cefdinir is marketed primarily as 300 mg capsules and a 250 mg/5 mL powder for oral suspension. The FDA-approved suspension contains sucrose and must be shaken before administration. Cefdinir also forms a clinically relevant complex with iron, which can reduce absorption and cause reddish stools. These attributes create formulation and labeling opportunities but also impose development constraints. [1]

What is cefdinir and how is it marketed?

Cefdinir is a broad-spectrum oral cephalosporin indicated for selected bacterial infections, including acute bacterial otitis media, community-acquired pneumonia, acute maxillary sinusitis, pharyngitis or tonsillitis, uncomplicated skin infections, and acute exacerbations of chronic bronchitis in approved populations. [1]

Attribute	Cefdinir
Drug class	Oral third-generation cephalosporin
Active ingredient	Cefdinir
Common dosage forms	Capsules and powder for oral suspension
Capsule strengths	300 mg; some markets also have 100 mg
Suspension strength	250 mg/5 mL
Administration	Once or twice daily, depending on indication and age
Prescription status	Prescription antibiotic
Primary commercial segments	Pediatric infection treatment, adult oral therapy, institutional and retail generic supply
Key formulation issue	Iron interaction and suspension palatability
Original reference brand	Omnicef, associated with Abbott Laboratories
Current market structure	Generic, multi-supplier market

The original Omnicef product lost its commercial exclusivity years ago. Current commercial value is therefore linked to manufacturing cost, product quality, pharmacy availability, contracting, and formulation differentiation rather than conventional brand exclusivity.

What excipients are used in cefdinir formulations?

Cefdinir excipients vary by manufacturer, dosage form, geography, and regulatory filing. The most important excipient functions are powder flow, capsule fill uniformity, suspension redispersibility, taste masking, viscosity control, preservation, color, and patient acceptability.

Cefdinir capsule excipient strategy

Capsules generally require a compact excipient system that supports high-dose powder filling and content uniformity. Typical functions include:

Excipient function	Commercial purpose
Diluent	Adjusts fill weight and supports dose uniformity
Glidant	Improves powder flow during encapsulation
Lubricant	Reduces tooling and capsule-machine friction
Disintegrant	Promotes release after ingestion
Capsule shell	Provides dosage-form integrity and branding
Colorant or imprint ink	Supports product identification and anti-error controls

Approved products may use excipients such as microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, titanium dioxide, gelatin, and approved colorants. The exact composition must be confirmed against the current manufacturer label and the relevant regulatory filing. FDA labeling identifies the inactive ingredients for each approved product. [1]

For capsule manufacturers, the principal development issue is not achieving a novel release profile. Cefdinir is an immediate-release product. The objective is robust powder handling, consistent potency, rapid disintegration, low capsule-to-capsule variability, and stable packaging.

Oral suspension excipient strategy

Cefdinir suspension presents the stronger commercial opportunity because pediatric patients are more sensitive to taste, texture, dosing convenience, and storage requirements.

A suspension platform commonly requires:

• Suspending agents to prevent rapid settling.
• Wetting agents to disperse cefdinir particles.
• Sweeteners to reduce bitterness.
• Flavors to improve acceptance.
• Buffers to control pH.
• Preservatives where required.
• Colorants for product identification.
• Bulking agents, such as sucrose, to produce acceptable mouthfeel and powder volume.
• Anticaking or flow aids for reconstitution performance.

The reference cefdinir oral suspension contains sucrose and has an orange-colored, strawberry-flavored presentation in the FDA labeling. After reconstitution, the product is stored under labeled conditions and has a limited in-use period. [1]

A developer seeking differentiation should examine the following attributes:

Target attribute	Formulation opportunity
Taste	Improved bitterness suppression and flavor persistence
Sugar content	Reduced-sugar or sugar-free suspension
Reconstitution	Faster wetting, lower foaming, fewer agglomerates
Redispersibility	Controlled sedimentation and easy shaking
Dose accuracy	More consistent syringe withdrawal across the bottle
Stability	Longer usable period after reconstitution
Packaging	Unit-dose cups, oral-syringe systems, smaller bottle sizes
Patient acceptance	Lower viscosity, less residue, improved mouthfeel
Label compatibility	Clear warnings for iron-containing products

How does iron interaction affect cefdinir excipient selection?

Iron interaction is a central constraint in cefdinir product design and patient counseling. Cefdinir can bind with iron in the gastrointestinal tract. The interaction may reduce cefdinir absorption and produce reddish-colored stools. The FDA label advises that iron-containing products, including multivitamins with iron, may interact with cefdinir. [1]

This issue affects excipient strategy in four ways.

First, an oral formulation should not introduce unnecessary iron-containing excipients or mineral systems. Iron salts are not standard functional excipients for cefdinir and would create avoidable compatibility and labeling problems.

Second, developers should assess whether colorants, mineral-based processing aids, or contaminated raw materials could contribute to iron exposure. Supplier specifications should control elemental iron and trace-metal content.

Third, pediatric packaging and labeling should distinguish cefdinir from iron-containing supplements. A dosing card or oral-syringe label can include a concise separation warning.

Fourth, any modified-release, lipid, chelation, or mineral-containing delivery system requires focused pharmacokinetic assessment. The formulation should not increase the opportunity for cefdinir to bind iron or other polyvalent cations before absorption.

The interaction does not generally create a new composition-of-matter patent opportunity. It creates a product quality, labeling, and patient-use risk that can be managed through excipient selection and instructions.

What formulations are protected or commercially differentiated for cefdinir?

The principal cefdinir formulation categories are immediate-release capsules and powder for oral suspension. Commercial differentiation is more likely to arise from formulation know-how, manufacturing controls, packaging, and regulatory execution than from a strong current patent position.

Immediate-release capsules

Capsules can be differentiated through:

• Lower-cost high-speed encapsulation.
• Improved powder flow.
• Reduced capsule weight.
• Lower moisture uptake.
• Enhanced stability in hot and humid climates.
• Blister packaging for unit-dose distribution.
• 100 mg and 300 mg strength availability.
• Pediatric and geriatric dose flexibility through strength combinations.

A capsule composition patent could theoretically cover a specific excipient ratio, particle-size distribution, manufacturing process, or stability profile. Its commercial value would depend on claim scope, remaining term, enforceability, and whether competing products use materially different compositions.

Powder for oral suspension

The oral suspension has more potential for protectable product attributes, including:

• Sugar-free compositions.
• Novel taste-masking systems.
• Improved reconstitution technology.
• Long-term stability after reconstitution.
• Reduced sedimentation.
• Low-volume or concentrated dosing.
• Improved iron-compatibility labeling and delivery.
• Ready-to-use liquid suspension.
• Unit-dose packaging.

A concentrated suspension could reduce shipping volume and improve pharmacy storage economics. It would also require dose-volume, viscosity, dosing-device, and safety validation. A ready-to-use liquid could improve caregiver convenience but would impose a heavier shipping burden and may face greater microbial and stability requirements.

When does cefdinir lose exclusivity?

Cefdinir has already lost its original small-molecule market exclusivity. The product is available from multiple generic manufacturers in the United States and other markets.

Exclusivity category	Cefdinir status
New chemical entity exclusivity	Expired
Original brand exclusivity	Expired
Basic small-molecule patent barrier	No longer the principal commercial barrier
Generic availability	Established
Biosimilar pathway	Not applicable
Current competitive barrier	Manufacturing, quality, supply, contracting, and regulatory approval
Product-specific formulation protection	Depends on individual manufacturer patents and claims

A new cefdinir product would generally follow an abbreviated or generic regulatory pathway if it is therapeutically equivalent to an approved reference product. A materially different dosage form, strength, delivery system, or formulation could require a different FDA submission strategy.

What is the FDA regulatory status of cefdinir?

Cefdinir is an FDA-approved prescription antibiotic. Approved dosage forms include capsules and oral suspension. Generic applicants typically demonstrate pharmaceutical equivalence and bioequivalence to the reference product, subject to the applicable FDA pathway and product-specific requirements. [1,2]

The main regulatory considerations are:

1. Active ingredient identity, assay, impurities, and polymorphic or solid-state control.
2. Dissolution and release performance for capsules.
3. Reconstitution and redispersibility for suspension.
4. Microbial quality and preservative effectiveness where applicable.
5. Stability before and after reconstitution.
6. Dose uniformity across the bottle.
7. Container-closure compatibility.
8. Labeling for iron interaction.
9. Pediatric acceptability and dosing-device accuracy.
10. Manufacturing-site compliance and supply reliability.

A new formulation that changes excipients substantially may require comparative bioavailability work. A product that changes concentration, dosing volume, or release behavior could generate additional regulatory requirements.

Does cefdinir have Orange Book-listed patents?

Cefdinir’s original Orange Book exclusivity has expired, and the product is broadly generic. Orange Book status must be assessed by product and sponsor because listed patents, delisting events, and approved presentations can change. FDA’s electronic Orange Book remains the controlling source for current listed patents and exclusivity information. [2]

For commercial diligence, a cefdinir applicant should review:

• The current reference-listed drug.
• Active ingredient and dosage-form entries.
• Any remaining listed patents.
• Pediatric exclusivity entries.
• Approved strengths and presentations.
• Therapeutic-equivalence codes.
• Patent certifications in abbreviated new drug applications.
• FDA approval letters and labeling revisions.

A formulation developer should not assume that an expired molecule has no relevant IP. A sponsor may hold later patents covering a particular suspension, flavor system, dosing concentration, packaging configuration, or manufacturing process. Such patents may have narrower claims and shorter commercial value than the original drug patents.

Are Paragraph IV challenges relevant to cefdinir?

Paragraph IV litigation is possible when an applicant certifies that a listed patent is invalid, unenforceable, or will not be infringed. For a mature generic product such as cefdinir, Paragraph IV risk is generally lower than for a recently launched branded drug because the core patent estate has aged out.

The principal risk would arise from a later-listed formulation or method-of-use patent. Potential targets could include:

• A new pediatric suspension formulation.
• A concentrated or ready-to-use liquid.
• A novel taste-masking composition.
• A specialized packaging system.
• A new method of administration.
• A specific impurity-control or manufacturing process patent.

For a standard cefdinir capsule or conventional suspension, market entry risk is more likely to involve FDA review, manufacturing readiness, product quality, and commercial contracting than a major patent block.

What commercial opportunities exist for cefdinir excipients?

Sugar-free pediatric suspension

A sugar-free suspension is the clearest excipient-led opportunity. It could target children requiring reduced sugar intake, families concerned about dental exposure, and institutions seeking lower sugar loads across repeated antibiotic courses.

Potential excipient systems include polyols, high-intensity sweeteners, soluble fibers, and non-sucrose bulking agents. The formulation must control bitterness without excessive cooling sensation, laxation risk, viscosity, or aftertaste.

The commercial value would depend on proving that the product is:

• Stable through the labeled shelf life.
• Easy to reconstitute.
• Acceptable to children.
• Compatible with oral syringes.
• Microbiologically controlled.
• Bioequivalent or otherwise approvable under the selected pathway.

Improved taste masking

Cefdinir’s pediatric use makes palatability commercially relevant. Taste-masking systems may include polymer coating, ion-exchange resins, lipid barriers, cyclodextrin complexes, or optimized flavor and sweetener combinations.

The strongest commercial position would come from a measurable advantage, such as lower bitterness aftertaste, faster acceptance, reduced spit-out rates, or improved dosing completion. A flavor change alone is unlikely to produce durable differentiation unless it supports a broader product claim and is protected by defensible formulation IP.

Reduced reconstitution complexity

Pharmacies and caregivers benefit from powders that wet rapidly and form a uniform suspension without persistent clumps. A formulation that reconstitutes with fewer inversion cycles can reduce dispensing errors.

Commercial differentiation may include:

• Narrower particle-size distribution.
• Improved granule porosity.
• Controlled-density particles.
• Better wetting agents.
• Lower foam generation.
• More reliable final volume.
• Marked fill lines and supplied dosing syringes.

Extended post-reconstitution stability

A longer in-use period could reduce waste and improve treatment continuity. This opportunity is technically demanding because cefdinir suspension stability depends on chemical degradation, microbial control, container closure, pH, viscosity, and sedimentation.

A longer usable period is commercially valuable only if the product retains potency, acceptable appearance, uniform dosing, and microbiological quality through the proposed interval.

Ready-to-use liquid suspension

Ready-to-use cefdinir could eliminate pharmacy reconstitution and improve caregiver convenience. The disadvantages are higher shipping cost, greater storage volume, potential preservative burden, and increased sensitivity to temperature excursions.

This format may be most attractive for hospital discharge programs, pediatric clinics, emergency departments, and markets where pharmacy reconstitution infrastructure is inconsistent.

How strong is the cefdinir patent estate?

The cefdinir patent estate is weak at the core molecule level because cefdinir is a mature generic active ingredient. Product-specific formulation patents may still create narrow barriers, but they are unlikely to prevent broad generic competition unless they cover an essential, difficult-to-design-around performance attribute.

IP category	Relative strength
Cefdinir active ingredient	Low commercial protection
Standard capsule formulation	Low to moderate, depending on claims
Conventional suspension	Low to moderate
Sugar-free suspension	Potentially moderate
Taste-masked composition	Potentially moderate
Novel reconstitution system	Potentially moderate
Manufacturing process	Moderate if difficult to replicate and enforce
Packaging and dosing device	Usually narrow
Method-of-use patents	Limited value in a generic antibiotic market
Trade secrets	Relevant for process robustness and flavor systems

The strongest defensible position would combine a patentable formulation feature with measurable patient or manufacturing benefits. A simple substitution of one sweetener for another would be vulnerable to design-around and may not justify substantial legal expense.

Which companies are competing in the cefdinir market?

Cefdinir is supplied by multiple generic manufacturers and contract manufacturers. The commercial landscape can change as approvals, shortages, discontinuations, and wholesaler contracts shift.

Competition typically includes:

• Large generic pharmaceutical companies.
• Regional manufacturers.
• Contract development and manufacturing organizations.
• Private-label suppliers.
• Government and institutional suppliers.
• Pediatric-focused generic companies.

The relevant competitive variables are price, availability, bottle configuration, concentration, pharmacy substitution, shortage performance, manufacturing-site history, and wholesaler access.

Because cefdinir is an established generic, a new entrant would need a clear advantage in one of four areas:

1. Lower cost of goods.
2. More reliable supply.
3. Better pediatric usability.
4. A differentiated dosage form or package.

What licensing deals and partnerships could support cefdinir commercialization?

Cefdinir is suitable for asset-light licensing and supply arrangements rather than high-value molecule licensing. Potential structures include:

• In-licensing an approved suspension from a regional manufacturer.
• Contract manufacturing with a pediatric formulation specialist.
• Private-label supply for pharmacy chains.
• Co-development of sugar-free or ready-to-use suspension.
• Exclusive distribution in emerging markets.
• Technology licensing for taste masking or granulation.
• Hospital and institutional supply agreements.
• Dual-source agreements to reduce shortage exposure.

The most valuable partner would usually contribute an approved product, qualified manufacturing site, or differentiated formulation technology. A formulation-only license without regulatory or manufacturing support would have limited value in a price-sensitive generic category.

What manufacturing and IP barriers affect cefdinir?

The main barriers are operational rather than molecule-specific.

Manufacturing barriers

Cefdinir manufacturers must control:

• Powder flow and segregation.
• Particle-size distribution.
• Moisture sensitivity.
• Capsule fill weight.
• Suspension sedimentation.
• Reconstitution time.
• Microbial quality.
• Flavor uniformity.
• Bottle-fill accuracy.
• Stability under high humidity.
• Raw-material variability.

Suspensions create more batch-to-batch variability than capsules because particle interactions, granulation, flavor distribution, viscosity, and reconstitution performance must be controlled simultaneously.

Intellectual-property barriers

IP barriers may include:

• Later formulation patents.
• Process patents covering particle engineering.
• Taste-masking patents.
• Device patents for dosing systems.
• Packaging patents.
• Trade secrets around granulation, flavor, and suspension rheology.

Freedom-to-operate analysis should separate claims that cover the active ingredient from claims that cover excipients, process steps, packaging, and use instructions. A formulation can avoid a composition claim but still infringe a manufacturing-process claim.

How does cefdinir compare with competing oral antibiotics?

Cefdinir competes with other oral antibiotics used in similar pediatric and outpatient settings, including amoxicillin, amoxicillin-clavulanate, azithromycin, cephalexin, and other cephalosporins.

Commercial factor	Cefdinir	Amoxicillin	Amoxicillin-clavulanate
Generic maturity	High	High	High
Pediatric suspension importance	High	High	High
Taste-masking opportunity	High	High	High
Formulation complexity	Moderate	Moderate	Higher
Iron interaction concern	Notable	Less central	Less central
Sugar-free opportunity	Meaningful	Meaningful	Meaningful
Price pressure	High	Very high	High
Differentiation route	Suspension, taste, supply	Cost and convenience	Stability, tolerability, dosing
Biosimilar relevance	None	None	None

Cefdinir may command commercial preference in some prescribing situations because of dosing convenience and spectrum, but antibiotic stewardship, resistance patterns, payer controls, and clinical guidelines constrain demand. Excipients can improve product usability but cannot overcome clinical restrictions on antibiotic selection.

What generic launch scenarios exist for a new cefdinir product?

Standard capsule launch

This is the lowest-risk technical path and the most exposed to price competition. Success depends on low manufacturing cost, reliable supply, approved strengths, and wholesaler access.

Conventional suspension launch

This offers broader pediatric relevance but requires stronger controls over taste, reconstitution, stability, and packaging. A supplied oral syringe would improve product usability.

Sugar-free suspension launch

This offers a clear marketing position, particularly for pediatric and institutional channels. The product must avoid excessive sweetness, gastrointestinal tolerability issues, and complex storage requirements.

Ready-to-use liquid launch

This has the strongest convenience proposition but the highest logistics and stability burden. It is better suited to targeted channels than to broad low-price generic distribution.

Concentrated suspension launch

A lower dosing volume could improve caregiver acceptance and reduce packaging size. The product would require careful concentration, viscosity, dose-device, and bioavailability evaluation.

What geographic opportunities exist for cefdinir excipient innovation?

The largest practical opportunity may be markets with high pediatric demand, unreliable pharmacy reconstitution, hot and humid storage conditions, or limited cold-chain infrastructure.

A global product strategy should evaluate:

• Sucrose and colorant labeling requirements.
• Permitted preservatives.
• Local pediatric flavor preferences.
• Packaging material availability.
• Temperature and humidity stability.
• Local reference products.
• Bioequivalence standards.
• Language-specific dosing instructions.
• Antibiotic prescription controls.
• Procurement requirements.

A formulation that performs well in North America may require different excipient limits or packaging in Europe, Asia, Latin America, or the Middle East. The same suspension technology can support multiple regional products if the flavor, color, sweetener, and labeling systems are modular.

Key Takeaways

• Cefdinir is a mature generic antibiotic with no meaningful core-molecule exclusivity.
• The strongest commercial opportunity is a differentiated pediatric oral suspension.
• Sugar-free, taste-masked, concentrated, ready-to-use, and fast-reconstituting formats offer the clearest formulation strategies.
• Iron interaction must be addressed through excipient control, raw-material specifications, labeling, and patient-use instructions.
• Capsule products offer lower technical risk but face severe price competition.
• Suspension products require greater control of taste, sedimentation, viscosity, microbial quality, and post-reconstitution stability.
• Current commercial barriers are manufacturing reliability, regulatory execution, supply continuity, and payer economics.
• Biosimilar risk is not relevant because cefdinir is a small-molecule antibiotic.
• Later formulation patents may create narrow barriers, but standard cefdinir products remain highly vulnerable to design-around and generic competition.
• The most defensible product position combines a measurable pediatric usability benefit with efficient manufacturing and a focused patent or trade-secret strategy.

FAQs

Can cefdinir be formulated without sucrose?

Yes. A sugar-free cefdinir suspension can use alternative sweeteners, bulking agents, viscosity modifiers, and taste-masking technologies. The formulation must meet stability, palatability, microbial, reconstitution, and bioequivalence requirements.

Does cefdinir require a preservative in oral suspension?

Not necessarily. The requirement depends on water activity, packaging, in-use stability, formulation composition, microbiological controls, and the proposed storage period. A preservative-free product may be possible but requires appropriate validation.

Is a cefdinir oral suspension patentable?

A conventional suspension may have limited patent strength. A novel composition with improved taste, stability, reconstitution, concentration, or dosing performance may support composition, process, or use claims if the claims satisfy patentability standards.

Can cefdinir be combined with iron in one pediatric product?

Such a combination would be commercially and clinically unattractive because iron can reduce cefdinir absorption and cause a recognizable stool-color effect. A combined product would require strong pharmacokinetic and safety justification.

What is the most attractive cefdinir dosage form for licensing?

A differentiated pediatric suspension is generally more attractive than a standard capsule because it offers greater room for formulation, packaging, and patient-use differentiation. The value increases if the product has regulatory approval, stable supply, and defensible taste-masking or sugar-free technology.

References

1. U.S. Food and Drug Administration. (2024). Cefdinir prescribing information. DailyMed. https://dailymed.nlm.nih.gov/

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

3. U.S. Food and Drug Administration. (2015). Abbreviated new drug application submissions: Refuse-to-receive standards. FDA. https://www.fda.gov/

4. U.S. Food and Drug Administration. (2023). Guidance for industry: Bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an ANDA. FDA. https://www.fda.gov/