List of Excipients in Branded Drug CEFPROZIL

Generic Drugs Containing CEFPROZIL

Company	Ingredient	NDC	Excipient
Teva Pharmaceuticals USA Inc	cefprozil	0093-1077	CELLULOSE, MICROCRYSTALLINE
Teva Pharmaceuticals USA Inc	cefprozil	0093-1077	D&C YELLOW NO. 10 ALUMINUM LAKE
Teva Pharmaceuticals USA Inc	cefprozil	0093-1077	FD&C RED NO. 40
Teva Pharmaceuticals USA Inc	cefprozil	0093-1077	FD&C YELLOW NO. 6
Teva Pharmaceuticals USA Inc	cefprozil	0093-1077	HYPROMELLOSES
Teva Pharmaceuticals USA Inc	cefprozil	0093-1077	MAGNESIUM STEARATE
Teva Pharmaceuticals USA Inc	cefprozil	0093-1077	POLYETHYLENE GLYCOL 400

What are the Most Frequently-Used Excipients in CEFPROZIL?

# Of NDCs	Excipient
7	AMMONIA
4	ANHYDROUS CITRIC ACID
8	ASPARTAME
8	CARBOXYMETHYLCELLULOSE SODIUM
28	CELLULOSE, MICROCRYSTALLINE
1	CI 77499
4	CITRIC ACID MONOHYDRATE

Cefprozil Excipient Strategy and Commercial Opportunities

Last updated: September 24, 2026

Cefprozil is an off-patent, orally administered second-generation cephalosporin with limited differentiation at the active-ingredient level. Commercial opportunity is concentrated in formulation execution: palatability, suspension stability, dose accuracy, manufacturing efficiency, pediatric adherence, and reliable generic supply. The most attractive platform is cefprozil monohydrate powder for oral suspension, followed by low-cost film-coated tablets and differentiated pediatric presentations.

What is cefprozil and where does it compete?

Cefprozil is an oral cephalosporin antibacterial marketed historically under the brand name Cefzil. It has been supplied as 250 mg and 500 mg tablets and as powder for oral suspension. The drug is used for selected respiratory, skin, and urinary tract bacterial infections, subject to local labeling and antimicrobial stewardship requirements.[1]

Cefprozil is not a biologic and does not create biosimilar exposure. Competitive products are conventional generic antibiotics, primarily:

Product category	Competitive relevance
Cefprozil tablets	Direct dosage-form competition
Cefprozil oral suspension	Pediatric and swallowing-limited patient segment
Cefuroxime axetil	Competing oral second-generation cephalosporin
Cefdinir	Competing oral third-generation cephalosporin
Cefixime	Competing oral third-generation cephalosporin
Amoxicillin/clavulanate	Broad-spectrum alternative with greater gastrointestinal burden
Cephalexin	Lower-cost first-generation cephalosporin alternative

Cefprozil has high oral absorption relative to many beta-lactam products, and the FDA label states that food does not materially affect the extent of absorption.[1] These characteristics reduce the need for aggressive bioavailability enhancement. Excipient development should focus on physical stability, taste, manufacturability, and patient usability rather than complex drug-delivery technology.

What patents protect cefprozil?

Cefprozil’s active pharmaceutical ingredient and original branded formulations are no longer protected by meaningful U.S. market exclusivity.

Compound and formulation patent position

The original Cefzil development program dates to the pre-Hatch-Waxman era. Any original compound and formulation patents associated with cefprozil have expired. Cefprozil is therefore a conventional generic opportunity rather than an originator-protected product.

The relevant U.S. regulatory position is:

Issue	Cefprozil position
New chemical entity exclusivity	Expired
Original compound patent protection	Expired
Current branded market exclusivity	None identified
Biosimilar pathway	Not applicable
Paragraph IV risk	Limited to any newly listed patent, if present
Orange Book relevance	Product and patent-listing review remains required before filing
Main IP risk	New formulation, process, polymorph, packaging, or method-of-use claims

A sponsor should verify the current FDA Orange Book at filing because listings can change by product and application. The absence of active compound protection does not eliminate risk from a later-listed formulation or manufacturing patent.[2]

What patent estate can a new cefprozil product create?

A new product is unlikely to obtain broad protection over cefprozil itself. More realistic claim categories include:

• A narrowly defined cefprozil particle-size distribution.
• A selected crystalline or hydrate form.
• A taste-masked granule or multiparticulate.
• A reconstitutable suspension with improved chemical stability.
• A low-sugar or sugar-free suspension.
• A preservative-free multidose package with validated in-use stability.
• A high-concentration suspension that reduces administration volume.
• A specific dry-granulation or fluid-bed coating process.
• A unit-dose powder sachet or stick pack.
• A combination product with a separately patentable active ingredient.

These claims face obviousness and freedom-to-operate challenges because cefprozil is old and widely formulated. Commercial value will depend more on regulatory differentiation and supply reliability than on broad exclusionary patent rights.

What excipients are used in cefprozil tablets?

Cefprozil tablets generally require a conventional immediate-release tablet platform. The formulation objective is rapid disintegration, acceptable hardness, low friability, chemical stability, and cost control.

Typical excipient functions include:

Function	Candidate excipients	Development objective
Diluent	Microcrystalline cellulose, lactose, mannitol	Control tablet weight and compressibility
Binder	Hydroxypropyl cellulose, povidone	Improve granule and tablet strength
Disintegrant	Croscarmellose sodium, crospovidone, sodium starch glycolate	Achieve rapid breakup
Lubricant	Magnesium stearate, sodium stearyl fumarate	Prevent sticking and reduce ejection force
Glidant	Colloidal silicon dioxide	Improve powder flow
Film coating	Hypromellose, polyethylene glycol, titanium dioxide, iron oxides	Improve handling, appearance, and swallowability
Opacifier or colorant	Titanium dioxide or approved colorants	Product identification and light protection

The historical Cefzil tablet label identifies conventional inactive ingredients, with composition varying by strength and manufacturer.[1] Generic developers should not copy an originator formulation unnecessarily. A direct-compression formula may reduce processing steps, but wet granulation can improve content uniformity and flow if the cefprozil powder has unfavorable bulk properties.

What tablet excipient strategy is commercially strongest?

The lowest-risk strategy is a conventional film-coated tablet with:

1. A robust diluent-binder system.
2. A superdisintegrant at a level validated for rapid dissolution.
3. Magnesium stearate controlled to avoid dissolution impairment.
4. A moisture-managed coating process.
5. A color system that supports strength differentiation.

The principal development risks are not solubility enhancement but blend segregation, over-lubrication, tablet capping, and dissolution drift during stability testing. The final product should be evaluated against the reference product for assay, impurities, dissolution, hardness, friability, and stability under ICH conditions.

What excipients are used in cefprozil oral suspension?

Cefprozil suspension is the strongest excipient-led commercial opportunity because pediatric acceptability and reconstitution performance directly affect product use.

A dry powder for reconstitution commonly requires the following functional system:

Formulation need	Candidate excipient class	Commercial purpose
Sweetener	Sucrose, sucralose, saccharin sodium, acesulfame potassium	Reduce bitterness
Suspending agent	Xanthan gum, sodium carboxymethylcellulose, microcrystalline cellulose and carboxymethylcellulose	Maintain dose uniformity
Wetting agent	Polysorbate 80 or equivalent	Improve dispersion
Buffer	Citrate or phosphate system	Control pH and stability
Preservative	Sodium benzoate, potassium sorbate, or other approved system	Control microbial growth after reconstitution
Flavor	Cherry, berry, bubble gum, or fruit flavor	Improve pediatric acceptance
Bulking agent	Sucrose, mannitol, or other soluble solid	Support powder volume and mouthfeel
Anticaking aid	Colloidal silicon dioxide	Improve powder flow and reconstitution

The historical Cefzil suspension uses a sweetened, flavored, preserved system. The FDA labeling states that the reconstituted suspension is stable for a defined in-use period under labeled storage conditions.[1] A generic product must reproduce or exceed the reference product’s reconstitution, appearance, redispersibility, assay uniformity, impurity profile, and in-use stability.

Which suspension attributes create differentiation?

The highest-value attributes are:

• Lower administration volume through a higher concentration.
• Faster wetting and easier reconstitution.
• No hard sediment or caking after storage.
• Redispersibility with limited shaking.
• Consistent dosing throughout the bottle life.
• Reduced bitterness after swallowing.
• Clear storage instructions.
• Child-resistant packaging with a calibrated oral syringe.
• A preservative system that is effective without an objectionable taste.
• Sugar-free or lower-sugar positioning where clinically and commercially appropriate.

Taste masking is likely to create greater market value than a new tablet formulation. Cefprozil’s beta-lactam structure can produce bitterness, and sweetener alone may not adequately address aftertaste. Polymer-coated microparticles, ion-exchange resins, lipid barriers, or pH-triggered taste-masking systems could improve acceptability, but each adds manufacturing and bioequivalence complexity.

What formulation patents could protect a cefprozil product?

Formulation patentability depends on unexpected technical performance rather than the mere selection of a familiar excipient.

Stronger patent concepts

Potentially stronger claims would link the composition to measurable outcomes, such as:

• A cefprozil suspension with materially improved taste scores and unchanged antimicrobial potency.
• A coated cefprozil particle with reduced bitterness and rapid release after administration.
• A high-concentration suspension that maintains dose uniformity after extended standing.
• A sugar-free suspension with equivalent microbial protection and improved chemical stability.
• A dry powder system that reconstitutes without clumping at a defined water volume.
• A formulation with a specified impurity profile after accelerated storage.

Weaker patent concepts

The following approaches are more vulnerable to obviousness challenges:

• Substituting one conventional sweetener for another.
• Combining cefprozil with standard xanthan gum and a common preservative.
• Using a routine film coating on a conventional tablet.
• Changing colorants or flavor alone.
• Claiming a standard wet-granulation process without unexpected performance.

A sponsor should separate patent strategy from regulatory strategy. A product can be commercially differentiated without obtaining enforceable patent claims, while a technically patentable formulation may have limited market value if it requires expensive manufacturing or creates difficult bioequivalence work.

When does cefprozil lose exclusivity?

Cefprozil already operates in the post-exclusivity generic market.

The relevant timeline is:

Milestone	Status
Original Cefzil launch	Historical
Original small-molecule exclusivity	Expired
Original compound patent term	Expired
Generic entry	Established
Current opportunity	Formulation, supply, channel, and geographic execution
Biosimilar exclusivity	Not applicable

The market is therefore sensitive to price, availability, wholesaler access, state procurement, and product quality. A new entrant would not rely on launch exclusivity to support premium pricing.

What is the FDA and Orange Book status of cefprozil?

Cefprozil is an FDA-approved conventional small-molecule antibacterial. FDA-approved strengths and dosage forms have historically included tablets and oral suspension.[1]

The Orange Book remains the controlling source for current approved applications, therapeutic-equivalence evaluations, and any listed patents or exclusivity. Product status should be reviewed by application number and dosage form rather than by active ingredient alone.[2]

A generic sponsor should assess:

• Whether an active reference listed drug is available for the intended strength.
• Whether the reference product has current commercial supply.
• Whether a suitable reference product can be sourced for comparative testing.
• Whether the proposed strength has a current FDA-approved comparator.
• Whether the suspension concentration matches an approved reference.
• Whether inactive-ingredient differences affect labeling or safety review.
• Whether any listed patent requires a Paragraph IV certification.

What Paragraph IV challenges and litigation affect cefprozil?

Cefprozil’s original patent disputes are historical rather than central to current market entry. Because the compound is old and generic supply is established, the principal Paragraph IV exposure would arise only from a newly listed patent covering a later formulation, process, or delivery system.

Potential litigation triggers include:

• A branded reformulation with a newly listed patent.
• A high-concentration pediatric suspension.
• A taste-masked multiparticulate product.
• A novel fixed-dose combination.
• A manufacturing patent asserted against an abbreviated new drug application.
• A later-listed patent covering a specific dosage form or inactive-ingredient system.

A standard tablet or conventional powder-for-suspension ANDA is more likely to face ordinary regulatory and commercial competition than originator patent litigation. The sponsor must still conduct a current Orange Book and freedom-to-operate review before certification.

What commercial opportunities exist for cefprozil?

Pediatric suspension platform

The clearest opportunity is a reliable pediatric suspension with better palatability, accurate dosing, and reduced administration volume. Buyers include retail pharmacies, pediatric practices, hospital systems, and public procurement programs.

Potential commercial specifications include:

• 125 mg/5 mL and 250 mg/5 mL presentations, where consistent with the applicable reference product.
• Calibrated oral syringe.
• High-density bottle with reduced headspace.
• Clear reconstitution mark.
• Improved flavor system.
• Stable in-use period supported by data.
• Child-resistant closure.
• Unit-of-use packaging for pharmacies and clinics.

Hospital and institutional supply

Hospitals and group purchasing organizations value supply continuity, predictable lead times, and low total acquisition cost. Cefprozil is not generally a high-complexity hospital product, but shortages or discontinuations can create temporary procurement opportunities.

A contract manufacturer with validated beta-lactam segregation, containment, and cleaning controls may offer a competitive advantage. Cephalosporin manufacturing requires dedicated or appropriately controlled facilities and documented cross-contamination controls.

Geographic expansion

Cefprozil’s commercial profile may be stronger in markets where oral cephalosporins remain commonly prescribed and pediatric liquid antibiotics have stable demand. Regulatory requirements differ materially across the United States, European Union, Canada, Latin America, and Asia-Pacific.

Expansion priorities include:

• Local pediatric labeling requirements.
• Approved flavor and color systems.
• Preservative restrictions.
• Reconstitution water instructions.
• Climatic-zone stability testing.
• Local bioequivalence standards.
• Packaging requirements for measuring devices.
• Country-specific antibiotic stewardship policies.

A powder-for-suspension product can offer logistical advantages over a ready-to-use liquid because of lower shipping weight and improved shelf-life before reconstitution.

How does cefprozil compare with competing oral cephalosporins?

Attribute	Cefprozil	Cefuroxime axetil	Cefdinir	Cefixime
Product class	Second-generation cephalosporin	Second-generation cephalosporin prodrug	Third-generation cephalosporin	Third-generation cephalosporin
Main formulation opportunity	Taste-masked suspension	Suspension and tablet usability	Pediatric suspension	Pediatric suspension
Excipient complexity	Moderate	Moderate to high because of prodrug properties	Moderate	Moderate
Active patent barrier	Expired	Largely expired	Largely expired	Largely expired
Main commercial differentiator	Palatability, supply, concentration	Tolerability and formulation	Dosing convenience	Dosing convenience
Biosimilar exposure	None	None	None	None

Cefprozil can compete effectively where prescribers value an oral cephalosporin with established tablet and suspension formats. It is less attractive where formularies prioritize once-daily dosing, broader spectrum, or very low-cost first-generation cephalosporins.

How strong is the cefprozil patent estate?

The cefprozil patent estate is weak for broad market exclusion and potentially useful for narrow formulation claims.

Patent category	Strength
Original cefprozil compound	Expired
Original tablet composition	Expired or commercially nonexclusive
Conventional suspension	Weak
Taste-masked multiparticulate	Moderate if supported by unexpected data
High-concentration suspension	Moderate, depending on prior art
Process patent	Narrow and vulnerable to design-around
Packaging or dosing device	Limited
Method of use	Limited unless tied to a new indication or regimen

The best intellectual-property strategy is a layered portfolio covering formulation, process, packaging, and device claims. The portfolio should be supported by comparative data rather than nominal excipient selection.

What revenue exposure and launch scenarios exist?

Cefprozil is unlikely to support originator-level pricing. Revenue depends on volume, channel access, and manufacturing cost.

Generic launch scenarios

Scenario	Product	Expected commercial profile
Cost-minimizing entry	Conventional tablets	High price pressure, low development complexity
Pediatric-focused entry	Standard suspension	Moderate opportunity, stronger differentiation
Premium generic	Taste-masked or high-concentration suspension	Higher development cost, potential pricing advantage
Institutional supplier	Tablets plus suspension	Volume-driven, tender and supply-chain dependent
Regional platform	Localized suspension and packaging	Regulatory investment with geographic upside

The suspension has the best possibility of maintaining margin because caregivers and pharmacists can value ease of use. The tablet market is more exposed to commoditization and substitution.

Key Takeaways

• Cefprozil is an off-patent oral cephalosporin with no biosimilar pathway.
• Current commercial value lies in formulation execution, not active-ingredient exclusivity.
• Powder for oral suspension offers the strongest excipient-led opportunity.
• Taste masking, redispersibility, dose uniformity, and lower administration volume are the most valuable product attributes.
• Conventional tablets are technically straightforward but face severe price competition.
• New patent protection would likely be narrow and depend on unexpected technical results.
• A current Orange Book and freedom-to-operate review remains necessary before filing.
• Cephalosporin containment, cleaning validation, and supply reliability can create manufacturing advantages.
• Geographic opportunities depend on pediatric antibiotic demand, local excipient rules, labeling, and procurement systems.
• A commercially viable cefprozil program should prioritize a differentiated suspension, robust packaging, and low-cost manufacturing.

FAQs

Can cefprozil be formulated as a sugar-free suspension?

Yes. A sugar-free system can use polyols or high-intensity sweeteners with a polymeric suspending system and an effective preservative. The key development risks are bitterness, mouthfeel, microbial control, and dose uniformity.

Is cefprozil suitable for an orally disintegrating tablet?

Potentially, but the opportunity is limited by dose size, taste, and tablet loading. A cefprozil orally disintegrating tablet would require effective taste masking and rapid disintegration without compromising dissolution or stability.

What is the best preservative for cefprozil suspension?

No single preservative is universally optimal. Sodium benzoate and potassium sorbate are practical candidates, but selection depends on pH, concentration, microbial challenge results, flavor impact, and regional regulatory acceptance.

Can a cefprozil suspension be protected with a new patent?

Yes, but a broad patent is unlikely. A stronger application would claim a defined formulation linked to improved taste, stability, reconstitution, redispersibility, or dose uniformity supported by comparative data.

Does cefprozil require special manufacturing controls?

Yes. As a cephalosporin, cefprozil manufacturing requires validated containment, cleaning, segregation, and cross-contamination controls. These requirements can materially affect facility selection, batch size, capital cost, and contract-manufacturing economics.

References

1. U.S. Food and Drug Administration. (2010). Cefzil (cefprozil) tablets and powder for oral suspension: Prescribing information. Bristol-Myers Squibb Company.

2. U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA Center for Drug Evaluation and Research.

3. National Library of Medicine. (2025). Cefprozil: Drug information and labeling records. DailyMed.

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