CEFPROZIL Drug Patent Profile

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Which patents cover Cefprozil, and when can generic versions of Cefprozil launch?

Cefprozil is a drug marketed by Apotex Inc, Aurobindo Pharma, Chartwell Rx, Lupin, Orchid Hlthcare, Ranbaxy Labs Ltd, Sandoz, Alkem Labs Ltd, Teva, and Wockhardt. and is included in sixteen NDAs.

The generic ingredient in CEFPROZIL is cefprozil. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the cefprozil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cefprozil

A generic version of CEFPROZIL was approved as cefprozil by CHARTWELL RX on November 14^th, 2005.

Summary for CEFPROZIL

US Patents:	0
Applicants:	10
NDAs:	16
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	15
Patent Applications:	7,355
Drug Prices:	Drug price information for CEFPROZIL
DailyMed Link:	CEFPROZIL at DailyMed

See drug prices for CEFPROZIL

See drug sales revenues for CEFPROZIL

Recent Clinical Trials for CEFPROZIL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Medical College of Wisconsin	PHASE4
The Affiliated Hospital of Qingdao University	Phase 1
University of Louisville	Early Phase 1

See all CEFPROZIL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CEFPROZIL

J01DC	Second-generation cephalosporins
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for CEFPROZIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wockhardt	CEFPROZIL	cefprozil	TABLET;ORAL	065428-002	Jun 14, 2007		DISCN	No	No
Ranbaxy Labs Ltd	CEFPROZIL	cefprozil	TABLET;ORAL	065198-002	Dec 13, 2006		DISCN	No	No
Teva	CEFPROZIL	cefprozil	TABLET;ORAL	065208-001	Dec 6, 2005	AB	RX	No	No
Apotex Inc	CEFPROZIL	cefprozil	FOR SUSPENSION;ORAL	065351-001	Feb 29, 2012		DISCN	No	No
Apotex Inc	CEFPROZIL	cefprozil	TABLET;ORAL	065327-002	Mar 26, 2008		DISCN	No	No

Cefprozil Market Dynamics, Patent Status, Generic Competition, and Financial Trajectory

Last updated: October 31, 2026

Cefprozil is a mature oral second-generation cephalosporin with no meaningful brand franchise remaining in the United States. The product was originally marketed as Cefzil by Bristol-Myers Squibb and is now supplied primarily through generic tablets and oral suspension. Its patents and regulatory exclusivity expired years ago, generic competition is established, and current commercial value depends on low-cost manufacturing, reliable supply, and institutional contracts rather than product differentiation.

Cefprozil has limited growth potential. Demand is tied to routine treatment of selected bacterial infections, but stewardship programs, resistance concerns, broad generic substitution, and competition from cephalexin, cefuroxime, cefdinir, and amoxicillin-clavulanate constrain pricing and volume.

What is cefprozil and how is it used?

Cefprozil is an orally administered beta-lactam antibiotic in the cephalosporin class. It is available in tablet and oral suspension dosage forms. The FDA-approved label covers susceptible bacterial infections including selected respiratory tract infections, skin and skin-structure infections, and urinary tract infections, depending on the product labeling and patient population [1].

Cefprozil dosage forms and strengths

Commercially recognized dosage forms include:

Dosage form	Common strengths	Primary commercial users
Immediate-release tablets	250 mg, 500 mg	Retail and mail-order pharmacies
Oral suspension	250 mg/5 mL	Pediatric and outpatient markets

Cefprozil is administered orally, which avoids the administration costs associated with injectable cephalosporins. Its clinical positioning is weaker than that of some competing oral antibiotics because many outpatient infections can be treated with lower-cost first-generation cephalosporins or penicillin-based therapies.

What is the FDA regulatory status of cefprozil?

Cefprozil was approved in the United States under the Cefzil brand in the early 1990s. Generic versions are approved through abbreviated new drug applications, or ANDAs, that rely on the reference product’s safety and efficacy record and demonstrate pharmaceutical equivalence and bioequivalence [2].

The product is not a biologic and does not qualify for biosimilar competition. Generic competitors are conventional small-molecule ANDA applicants.

Key FDA milestones

Regulatory event	Status
Original U.S. approval	Early 1990s
Reference product	Cefzil
Original sponsor	Bristol-Myers Squibb
Current regulatory pathway	ANDA-based generic approvals
Dosage forms	Tablets and oral suspension
Biologic exclusivity	Not applicable
Pediatric exclusivity	No current commercial relevance
FDA exclusivity position	Expired
Brand commercial position	Discontinued or commercially inactive in the U.S.

The FDA Orange Book includes discontinued-product information and patent listings for approved products. Cefprozil’s commercial status is consistent with a mature generic product rather than an active branded medicine [3].

When did cefprozil lose market exclusivity?

Cefprozil lost meaningful U.S. market exclusivity in the 1990s. The reference product’s commercial protection has long expired, allowing generic manufacturers to enter the market.

The precise original patent estate is difficult to translate into a current commercial barrier because the relevant composition, use, and pharmaceutical patents are no longer active. Any patent term extension or pediatric extension associated with the original product would also have expired.

Cefprozil exclusivity timeline

Period	Commercial position
Early 1990s	Cefzil launched as an innovator product
Mid-to-late 1990s	Core regulatory and patent protection expired or approached expiry
Late 1990s onward	Generic entry and price competition
2000s	Brand economics deteriorated; generic supply became dominant
2010s onward	Mature, low-margin generic market
Current market	Commodity oral antibiotic with limited pricing power

What patents protect cefprozil?

No active U.S. patent estate is generally associated with cefprozil as a commercially protected product. The original patents covering cefprozil’s active pharmaceutical ingredient, pharmaceutical compositions, or approved uses are expired.

Patent category	Current commercial relevance
Active ingredient or compound patents	Expired
Tablet formulation patents	No known active protection supporting a branded U.S. franchise
Oral suspension formulation patents	Expired or commercially immaterial
Method-of-use patents	No current exclusivity barrier of material importance
Manufacturing patents	Potentially relevant as trade secrets or process know-how, but not a market-excluding patent barrier
Orange Book-listed patents	No active listing supporting delayed generic entry

Patent protection should be distinguished from manufacturing know-how. A manufacturer may still protect crystallization, impurity control, particle-size management, or sterile-free suspension processing as confidential know-how. Those measures can reduce manufacturing risk but do not prevent competitors from producing cefprozil through alternative processes.

What is the Orange Book status of cefprozil?

Cefprozil’s Orange Book position is that of an old reference product with generic alternatives and no commercially meaningful unexpired patent exclusivity. The Orange Book remains the relevant FDA source for approved products, therapeutic equivalence codes, discontinued-product status, and listed patent information [3].

The absence of an active Orange Book patent means a new ANDA applicant would not face a current patent-based delay comparable to a Paragraph IV challenge against a protected branded product.

What does therapeutic equivalence mean for cefprozil?

Generic cefprozil products generally compete through therapeutic equivalence ratings, where applicable, and pharmacy substitution. Once multiple products are approved, purchasing decisions tend to depend on:

• Wholesale acquisition cost
• Medicaid and commercial reimbursement
• Manufacturer reliability
• Wholesaler availability
• Product recalls and shortage history
• Formulation acceptance, especially for pediatric suspension

For a mature oral antibiotic, these commercial factors usually matter more than patent strategy.

Are there Paragraph IV challenges to cefprozil?

Paragraph IV litigation is not a current central risk for cefprozil. Paragraph IV certifications are used when an ANDA applicant seeks approval before expiration of an Orange Book-listed patent and asserts that the patent is invalid, unenforceable, or not infringed. Cefprozil’s relevant patent protection expired long ago, so current generic entry does not depend on defeating a live branded patent estate.

Historical generic entry may have involved patent certifications or other regulatory disputes, but those events do not create present-day exclusivity. No current Paragraph IV dispute appears to support a meaningful delay in generic cefprozil availability.

What generic entry risks exist for cefprozil?

Generic entry risk is effectively realized rather than prospective. Multiple manufacturers can produce cefprozil, subject to FDA approval, current good manufacturing practice requirements, and supply-chain controls.

The main risks to incumbent manufacturers are commercial:

1. Further price erosion.
2. Loss of pharmacy or wholesaler contracts.
3. Manufacturing-site disruption.
4. FDA warning letters, recalls, or import restrictions.
5. Suspension raw-material shortages.
6. Reimbursement changes that favor substitute antibiotics.

A new entrant could still affect market economics if it offers lower prices or wins a large purchasing contract. However, the limited absolute market size reduces the incentive for aggressive investment unless the entrant already has a broad generic portfolio.

How strong is the cefprozil patent estate?

The patent estate is commercially weak because it is expired and no longer supports exclusivity. Cefprozil has no current patent-based defense against generic substitution.

Patent-strength assessment

Factor	Assessment
Core compound protection	Weak; expired
Formulation protection	Weak; no known active barrier
Method-of-use protection	Weak; no commercially meaningful current exclusivity
Manufacturing protection	Possible process know-how, but nonexclusive
Regulatory exclusivity	Expired
Generic substitution resistance	Low
Litigation leverage	Low
Opportunity for lifecycle management	Limited

A manufacturer could pursue an improved formulation, fixed-dose combination, or differentiated pediatric delivery system, but such a strategy would face clinical, regulatory, reimbursement, and market-adoption hurdles. The underlying cefprozil molecule does not provide a strong platform for premium pricing.

What formulations are protected by cefprozil patents?

No currently relevant formulation patent is known to protect a commercially differentiated U.S. cefprozil product. The principal formulations are immediate-release tablets and oral suspension. Both are technically established and vulnerable to generic competition.

A formulation strategy could focus on:

• Better suspension stability
• Improved taste masking
• Lower reconstitution burden
• Smaller tablet size
• Unit-dose packaging
• Extended shelf life after reconstitution

These attributes may support customer preference or contract wins, but they are unlikely to create durable market exclusivity without a new patentable formulation and a sufficiently large commercial opportunity.

How does cefprozil compare with competing oral antibiotics?

Cefprozil competes in a crowded oral anti-infective market. Its direct and indirect competitors include first-generation cephalosporins, later-generation cephalosporins, penicillin combinations, macrolides, and selected fluoroquinolones.

Product	Competitive position versus cefprozil
Cephalexin	Lower-cost first-generation cephalosporin; widely used
Cefuroxime axetil	Broader second-generation positioning; generic competition
Cefdinir	Pediatric and outpatient use; strong generic availability
Amoxicillin-clavulanate	Broad outpatient coverage; common guideline alternative
Cefpodoxime	Oral cephalosporin competitor with generic supply
Azithromycin	Alternative in selected respiratory indications
Levofloxacin	Different risk-benefit profile; used selectively

Cefprozil can benefit from established physician familiarity and oral dosing. It lacks, however, a strong current clinical or commercial feature that would support premium pricing over other generic antibiotics.

What is cefprozil’s market size and revenue trajectory?

Public companies generally do not report cefprozil revenue as a separate line item. The drug is typically included in broader generic pharmaceutical revenue, making a reliable standalone market-size estimate unavailable from public filings.

The financial trajectory is clear even without a product-level revenue series:

Period	Revenue and margin trend
Branded launch period	Higher price, stronger gross margin, sales-force support
Generic-entry period	Rapid price decline and volume transfer
Mature generic period	Low unit prices, fragmented supply
Current period	Limited revenue pool, low differentiation, contract-driven economics

Cefprozil’s value is likely concentrated in portfolio breadth rather than molecule-level profitability. A manufacturer with existing cephalosporin production, established oral-liquid capabilities, or a large retail distribution network can earn incremental value from the product. A stand-alone investment in cefprozil would face weak growth prospects.

What affects cefprozil profitability?

Profitability depends on:

• Active pharmaceutical ingredient cost
• Batch size and manufacturing utilization
• Packaging costs
• Oral-suspension reconstitution requirements
• Number of approved competitors
• Reimbursement and wholesaler discounts
• FDA compliance costs
• Product liability and recall exposure
• Contract volume

Tablet production can be economically viable at scale. Oral suspension can produce better customer retention in pediatric channels but has higher packaging, stability, and inventory-management complexity.

Which companies manufacture or market cefprozil?

Cefprozil has historically been marketed by Bristol-Myers Squibb under Cefzil and has been supplied by generic pharmaceutical companies through ANDA-approved products. Generic availability can vary by country, dosage form, and time because manufacturers may discontinue low-volume products or shift production between facilities.

The relevant competitive set includes generic manufacturers with oral solid-dose and oral-liquid capabilities. The commercial market is not controlled by a single active innovator. Company-level market share should be based on current FDA approval records, wholesaler data, and procurement contracts rather than legacy brand ownership.

What licensing deals affect cefprozil?

No major current licensing transaction is central to cefprozil’s commercial position. The product’s original brand rights were associated with Bristol-Myers Squibb, but the relevant licensing economics have been overtaken by generic competition.

Any current agreement is more likely to involve:

• Contract manufacturing
• Regional distribution
• Private-label supply
• Portfolio acquisition
• Authorized generic arrangements
• Technology transfer for oral suspension production

These arrangements generally do not create molecule-level exclusivity.

What patent litigation affects cefprozil?

Cefprozil does not appear to have an active U.S. patent litigation profile comparable to newer branded medicines. The commercially relevant legal risks are more likely to involve:

• ANDA product quality disputes
• Manufacturing-site compliance
• False advertising or labeling claims
• Supply agreements
• Product liability
• Antitrust issues involving generic contracting

There is no current evidence that patent litigation materially delays generic cefprozil entry or supports an innovator settlement strategy.

What generic launch scenarios exist for cefprozil?

The most likely market scenarios are:

Base case

Generic cefprozil remains available through a small group of manufacturers. Prices remain low, demand is stable or gradually declining, and revenue depends on supply reliability and portfolio economics.

Downside case

Manufacturers discontinue the product because of low margins, leaving intermittent supply and reduced pharmacy availability. A shortage could temporarily improve pricing but would not create durable value.

Upside case

A manufacturer improves pediatric suspension supply, secures institutional contracts, or benefits from temporary competitor exits. The upside would likely be volume-based and short-lived.

Strategic-repricing case

A manufacturer acquires or consolidates several generic suppliers and raises prices in a constrained channel. This strategy would face substitution risk, regulatory scrutiny, and the possibility of new entrants.

What geographic markets remain relevant for cefprozil?

Cefprozil’s strongest commercial relevance is in markets with established oral cephalosporin use, generic reimbursement, and outpatient antibiotic demand. Geographic value varies according to:

• Local treatment guidelines
• Antibiotic resistance patterns
• Prescription reimbursement
• Generic substitution rules
• National procurement systems
• Local manufacturing requirements
• Regulatory registration status

U.S. value is limited by mature generic competition. Emerging markets may offer volume, but price levels are typically lower and regulatory, distribution, and receivables risks are higher. European and other regulated markets may have limited commercial value because of extensive generic substitution and antimicrobial stewardship controls.

Key Takeaways

• Cefprozil is a mature oral second-generation cephalosporin with expired patent and regulatory exclusivity.
• Cefzil’s branded franchise no longer provides meaningful commercial protection.
• Generic competition is established, and current market entry does not depend on defeating active patents.
• No current Paragraph IV dispute or patent litigation appears to create a material market barrier.
• Tablets and oral suspension are the principal commercial formulations.
• Manufacturing reliability, cost control, and distribution contracts drive value.
• Standalone revenue is not generally disclosed by public companies.
• The product has limited growth potential and weak premium-pricing prospects.
• Cefprozil is not a biosimilar opportunity because it is a conventional small-molecule drug.
• Any investment case depends on portfolio scale, supply concentration, or temporary market disruption rather than patent strength.

FAQs About Cefprozil Market and Patent Risk

Is cefprozil still available in the United States?

Generic cefprozil has historically been available in tablet and oral-suspension forms, although availability can vary by manufacturer, wholesaler inventory, and product discontinuation status.

Does cefprozil have an active Orange Book patent?

Cefprozil does not have a commercially meaningful unexpired Orange Book patent estate supporting branded exclusivity.

Can a company launch a new generic cefprozil product?

Yes. A company can pursue an ANDA for a qualifying tablet or oral-suspension product, subject to FDA approval, bioequivalence, manufacturing compliance, and applicable labeling requirements.

Is cefprozil more valuable as a pediatric product?

The oral suspension gives cefprozil relevance in pediatric prescribing, but pediatric use does not by itself create exclusivity. Commercial value depends on taste, stability, availability, and reimbursement.

Could cefprozil prices increase after manufacturer exits?

Prices could rise temporarily if several suppliers discontinue the product or a shortage develops. Sustained pricing power would be difficult because the molecule is old, generic, and technically reproducible.

References

1. U.S. Food and Drug Administration. (1992). Cefzil (cefprozil) prescribing information. FDA.

2. U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application (ANDA) process. FDA.

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

4. National Library of Medicine. (n.d.). DailyMed: Cefprozil drug labeling. U.S. National Library of Medicine.

5. National Center for Biotechnology Information. (n.d.). PubChem compound summary: Cefprozil. PubChem.