CEFACLOR Drug Patent Profile

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Which patents cover Cefaclor, and what generic alternatives are available?

Cefaclor is a drug marketed by Ceph Intl, Chartwell Rx, Dava Pharms Inc, Hikma, Ivax Sub Teva Pharms, Ranbaxy, Teva, Yung Shin Pharm, Facta Farma, Watson Labs Inc, and World Gen. and is included in twenty-nine NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cefaclor

A generic version of CEFACLOR was approved as cefaclor by TEVA on September 4^th, 2002.

Summary for CEFACLOR

US Patents:	0
Applicants:	11
NDAs:	29
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	4
Patent Applications:	5,990
Drug Prices:	Drug price information for CEFACLOR
DailyMed Link:	CEFACLOR at DailyMed

See drug prices for CEFACLOR

Recent Clinical Trials for CEFACLOR

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

Sponsor	Phase
Fundacion Clinic per a la Recerca Biomédica	Phase 4
Julio Ramirez	Early Phase 1
University of Louisville	Early Phase 1

See all CEFACLOR clinical trials

Pharmacology for CEFACLOR

Drug Class

Cephalosporin Antibacterial

Medical Subject Heading (MeSH) Categories for CEFACLOR

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for CEFACLOR

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 CEFACLOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Yung Shin Pharm	CEFACLOR	cefaclor	FOR SUSPENSION;ORAL	065412-003	Feb 17, 2012		RX	No	No
Ranbaxy	CEFACLOR	cefaclor	FOR SUSPENSION;ORAL	064165-001	Oct 2, 1997		DISCN	No	No
World Gen	CEFACLOR	cefaclor	TABLET, EXTENDED RELEASE;ORAL	065057-001	Jan 5, 2001		DISCN	No	No
Ivax Sub Teva Pharms	CEFACLOR	cefaclor	FOR SUSPENSION;ORAL	064086-001	Apr 28, 1995		DISCN	No	No
Ranbaxy	CEFACLOR	cefaclor	FOR SUSPENSION;ORAL	064164-001	Oct 2, 1997		DISCN	No	No

Cefaclor Market Dynamics and Financial Trajectory: Generic Antibiotic Outlook

Last updated: October 12, 2026

Cefaclor is a mature, off-patent second-generation cephalosporin with limited commercial growth potential. The U.S. branded product, Ceclor, no longer drives the market. Revenue is concentrated in low-cost generic capsules, oral suspensions and, in some markets, extended-release tablets. Pricing pressure, substitution by newer oral antibiotics and reduced use of broad-spectrum antibiotics constrain long-term growth.

No reliable public source reports cefaclor revenue by manufacturer in the United States. Its financial trajectory is best assessed through regulatory status, generic competition, prescription volume, reimbursement pricing and supply continuity rather than branded sales forecasts.

What is cefaclor and which products contain it?

Cefaclor is an orally administered second-generation cephalosporin used against susceptible bacterial infections. It has activity against selected gram-positive and gram-negative organisms and is marketed in several oral dosage forms.

Attribute	Cefaclor profile
Active ingredient	Cefaclor
Drug class	Second-generation cephalosporin
Original U.S. brand	Ceclor
Original innovator	Eli Lilly and Company
U.S. first approval	1979
Administration	Oral
Common dosage forms	Capsules, oral suspension, extended-release tablets in certain markets
Main uses	Respiratory, ear, skin and urinary tract infections, subject to susceptibility
Regulatory category	Small-molecule prescription antibiotic
Current commercial status	Predominantly generic
Biosimilar exposure	None

The FDA-approved Ceclor labeling covered capsules and oral suspension. Ceclor CD, an extended-release formulation, was developed to improve dosing convenience but did not create a durable branded market after generic competition expanded.[1]

Cefaclor is not interchangeable with every oral cephalosporin. Prescribers may select cefalexin, cefuroxime, cefpodoxime or amoxicillin-clavulanate based on infection site, local resistance, allergy history, dosing requirements and formulary position.

When did cefaclor lose exclusivity?

Cefaclor lost practical U.S. market exclusivity decades ago. The original product entered the market in 1979, and generic competition subsequently eliminated the commercial protection associated with the Ceclor brand.

Small-molecule antibiotics are not subject to the biologic exclusivity framework that applies to biosimilars. Any initial regulatory exclusivity associated with the original NDA has long expired. Current cefaclor competition is governed primarily by generic ANDA approvals, manufacturing capacity and reimbursement economics.

Cefaclor exclusivity timeline

Event	Approximate timing	Commercial effect
Original U.S. approval of Ceclor	1979	Eli Lilly commercialized cefaclor
Original compound and product protection	Expired before the modern generic market	Generic entry became possible
Generic cefaclor approvals	Developed after innovator protection ended	Price competition increased
Ceclor brand decline	1990s-2000s	Branded revenue contracted
Current market	Generic-dominated	Low average selling prices and fragmented supply

Patent expiration dates for early cefaclor patents are no longer commercially material. The relevant question is not whether an active patent blocks generic entry, but whether manufacturers can maintain profitable supply under low reimbursement rates.

What patents protect cefaclor today?

No meaningful U.S. composition-of-matter patent protection remains for cefaclor. Current products are generally exposed to generic competition without a durable patent barrier.

The original cefaclor patent estate covered the active compound and related pharmaceutical chemistry. Those rights expired long ago. Formulation and dosage patents associated with extended-release products also do not create a current market-wide barrier comparable to an active new chemical entity patent.

Are cefaclor formulations protected by patents?

The principal formulation distinctions are:

• Immediate-release capsules
• Powder for oral suspension
• Extended-release tablets or capsules in selected markets
• Different strengths and pediatric concentrations

Formulation patents may have historically covered extended-release delivery systems, excipient combinations or manufacturing processes. Those rights do not protect the basic cefaclor market today. Generic manufacturers can compete through immediate-release products, and any remaining formulation-specific restrictions would affect only a narrow dosage-form segment.

The oral suspension category may have greater technical sensitivity than capsules because manufacturers must control particle size, stability, taste, reconstitution performance and antimicrobial preservation. These factors are manufacturing and regulatory barriers, not broad patent barriers.

What is the FDA regulatory status of cefaclor?

Cefaclor remains an FDA-recognized prescription antibiotic active ingredient, although the original Ceclor brand is not the principal source of current U.S. supply.

The FDA’s Orange Book identifies approved drug products and, where applicable, patents and regulatory exclusivity. For a mature generic such as cefaclor, the commercial market is generally based on abbreviated new drug applications rather than an active innovator franchise.[2]

FDA status by product category

Product category	Regulatory position
Cefaclor capsules	Generic prescription products
Cefaclor oral suspension	Generic prescription products
Ceclor branded products	Legacy innovator products; commercial availability may vary
Extended-release cefaclor	Limited market relevance compared with immediate-release forms
Injectable cefaclor	Not a standard U.S. cefaclor market category
Biosimilar products	Not applicable

FDA labeling warns about beta-lactam hypersensitivity and other adverse reactions. As with other antibiotics, cefaclor prescribing is affected by antimicrobial stewardship and the risk of inappropriate use.[1]

How many patents cover cefaclor?

There is no commercially significant active U.S. patent estate covering the core cefaclor molecule. The number of historical patents is less important than the absence of a current blocking patent position for standard generic presentations.

A practical patent assessment is:

Patent layer	Current relevance
Cefaclor composition patent	Expired
Original process patents	Expired or commercially nonblocking
Immediate-release capsule patents	No meaningful current barrier
Oral suspension patents	Limited commercial relevance
Extended-release formulation patents	Potentially relevant only to narrow dosage forms
Method-of-use patents	No broad current barrier to standard antibacterial use
Manufacturing know-how	Relevant to cost, quality and supply reliability

Are there Paragraph IV challenges for cefaclor?

Paragraph IV litigation is not a central current market issue for standard cefaclor products. Paragraph IV certifications are most valuable when a listed patent can delay generic entry into a high-value market. Cefaclor lacks the revenue scale and active patent structure that typically support substantial patent litigation.

Any historical ANDA filings may have used patent certifications, but the economic effect has passed because generic cefaclor has already entered the market. Current commercial risk is more likely to involve supply interruption, FDA manufacturing actions, product recalls or contract losses than a new Paragraph IV challenge.

Which companies are challenging or competing with cefaclor?

Cefaclor competes mainly with other oral antibiotics rather than through direct branded patent challenges. Generic suppliers may change over time as companies enter or exit the market.

Direct and therapeutic competitors

Competitor	Competitive relationship
Cefalexin	Lower-cost first-generation oral cephalosporin; often preferred for susceptible skin and soft-tissue infections
Cefuroxime axetil	Oral second-generation cephalosporin with different spectrum and dosing profile
Cefpodoxime	Oral third-generation cephalosporin used in selected indications
Amoxicillin-clavulanate	Major broad-spectrum alternative in respiratory and other infections
Azithromycin	Alternative in selected respiratory settings, subject to resistance considerations
Trimethoprim-sulfamethoxazole	Alternative for specific infections and susceptibility profiles

Cefaclor’s competitive position depends on local resistance, physician familiarity, payer formulary rules and the availability of lower-priced alternatives. It is not positioned as a premium antibiotic.

What generic entry risks exist for cefaclor?

Generic entry risk is already realized rather than prospective. Cefaclor has a mature generic market, so the central business risks are margin erosion and supply instability.

Key generic-market risks

1. Price compression. Multiple suppliers can compete for pharmacy and wholesaler contracts, reducing average selling prices.
2. Low-volume exits. Manufacturers may discontinue products when reimbursement no longer covers quality, regulatory and distribution costs.
3. Supplier concentration. A small number of active manufacturers can create vulnerability if one facility experiences a shortage or inspection issue.
4. Dosage-form imbalance. Capsules may have more suppliers than oral suspension, making pediatric presentations more exposed to shortages.
5. Substitution. Clinicians can move patients to cefalexin, amoxicillin-clavulanate or other oral antibiotics.
6. Antimicrobial stewardship. Hospitals and health systems increasingly restrict unnecessary broad-spectrum antibiotic use.

A generic entrant would face low patent risk but also limited pricing power. The business case would depend on manufacturing efficiency, reliable API procurement, stable FDA compliance and access to pharmacy or institutional contracts.

What is the financial trajectory for cefaclor?

Cefaclor’s financial trajectory is structurally mature to declining in branded terms and stable-to-declining in generic terms. It is unlikely to produce meaningful revenue growth without a new delivery format, geographic expansion or a supply disruption affecting competitors.

Revenue trajectory

Period	Financial profile
1979-1980s	High-value branded growth following launch
1990s	Mature branded product with expanding generic pressure
2000s	Major decline in branded economics; generic substitution increased
2010s	Low-price generic market with fragmented suppliers
2020s	Mature, low-growth product; value tied to supply continuity and selected markets

Public company filings generally do not isolate cefaclor revenue because it is sold as part of broader generic portfolios. Product-level revenue estimates from commercial databases may differ substantially depending on whether they measure manufacturer sales, pharmacy spending, tender sales or retail prescriptions.

Financial drivers

Volume

Volume is supported by the continued use of oral antibiotics in outpatient care. It is constrained by:

• Generic alternatives with stronger prescribing familiarity
• Antibiotic resistance
• Treatment guidelines favoring narrower-spectrum drugs where appropriate
• Reduced use for viral respiratory illness
• Product discontinuations and formulary changes

Price

Pricing is low relative to patented or branded antibiotics. Price increases may occur during shortages, but they are difficult to sustain when alternative cephalosporins and penicillin-based antibiotics are available.

Gross margin

Generic margins depend on scale. Capsule production may be relatively straightforward, while oral suspension production requires additional controls for stability, flavoring, reconstitution and packaging. Smaller suppliers may face unfavorable economics even when demand remains steady.

Geographic mix

The United States is a mature generic market. Cefaclor may retain stronger relevance in selected international markets where prescribing practice, branded-generic competition and local manufacturing differ. Pricing and market access vary by country, and U.S. revenue assumptions should not be applied globally.

What manufacturing and intellectual-property barriers affect cefaclor?

Cefaclor has low intellectual-property barriers but moderate operational barriers.

Manufacturers must demonstrate identity, strength, purity, dissolution, stability and microbiological quality. Oral suspension products add requirements for particle uniformity, reconstitution, palatability and in-use stability. Beta-lactam manufacturing may require dedicated or segregated facilities to manage cross-contamination risk.

Manufacturing risk matrix

Barrier	Impact on market
API availability	Can affect continuity and cost
Beta-lactam facility controls	Raises compliance and capital requirements
FDA inspection status	Can remove a supplier from the market
Suspension stability	Limits reliable pediatric supply
Packaging and reconstitution performance	Affects recalls and customer acceptance
Low reimbursement	Reduces incentives for redundant capacity

The combination of low selling prices and quality-system costs explains why older antibiotics can experience shortages even when the underlying chemistry is well established.

What patent litigation and settlement agreements affect cefaclor?

No current, high-value patent litigation is a defining feature of the cefaclor market. The commercial lifecycle is too mature for a conventional innovator-generic settlement to drive market timing.

Historical litigation, if any, would have centered on generic entry, formulation rights or manufacturing processes. Those disputes do not materially change the present U.S. market outlook. Settlement agreements are not a meaningful source of current cefaclor valuation.

What is the Orange Book status of cefaclor?

The Orange Book remains the relevant FDA reference for approved U.S. drug products, therapeutic equivalence and listed patents. Cefaclor should be evaluated product by product because approved dosage forms, marketing status and active manufacturers can change.[2]

For investment and licensing analysis, the key Orange Book conclusions are:

• Cefaclor is not protected by a current core composition patent.
• Generic substitution is the dominant U.S. commercial model.
• Patent-based launch delays are not the principal market variable.
• Product availability and therapeutic-equivalence listings matter more than exclusivity.
• A discontinued brand listing does not necessarily mean that generic cefaclor is unavailable.

How does cefaclor compare with cefalexin and cefuroxime?

Factor	Cefaclor	Cefalexin	Cefuroxime axetil
Generation	Second	First	Second
Market maturity	Very mature	Very mature	Mature
Patent barrier	None of commercial importance	None of commercial importance	None of commercial importance for standard generic products
Typical commercial position	Low-cost alternative	Often lower-cost, high-volume alternative	Broader branded and generic history
Pediatric use	Oral suspension available	Oral suspension available	Suspension and tablets, depending on market
Growth outlook	Flat to declining	More durable volume in established uses	Dependent on indications and pricing
Main risk	Substitution and supply	Price competition	Competition and formulation economics

Cefalexin often has stronger volume economics because of its established use in skin and soft-tissue infections and its lower-cost positioning. Cefuroxime may retain a role where its spectrum or dosing is preferred, but it also faces generic price pressure.

What generic launch scenarios are realistic?

A new cefaclor generic launch would most likely follow one of three paths:

Low-price retail launch

A manufacturer enters with immediate-release capsules and competes through wholesalers and pharmacy benefit channels. This path has low patent risk but limited margin and requires scale.

Pediatric-suspension niche

A supplier targets oral suspension availability, where fewer reliable manufacturers may operate. The opportunity is more dependent on supply shortages and contract access than on premium pricing.

International or tender-market launch

A manufacturer focuses on markets where cefaclor remains established or where government tenders reward dependable supply. This approach can generate volume but normally produces low unit prices.

An extended-release launch would face greater formulation and regulatory complexity without a clear premium market unless a specific country has meaningful unmet demand.

What is the biosimilar risk for cefaclor?

Biosimilar risk is not applicable. Cefaclor is a chemically synthesized small molecule, not a biologic. Competition occurs through generic drug applications and national equivalents, including ANDA-based products in the United States.

The relevant competitive risk is substitution by other antibiotics and new generic suppliers, not biosimilar entry.

Key Takeaways

• Cefaclor is a mature, generic-dominated oral antibiotic.
• The original Ceclor brand no longer provides a meaningful U.S. growth platform.
• Core composition and conventional formulation patent protection have expired.
• Paragraph IV litigation and patent settlements are not current market drivers.
• No biosimilar pathway applies.
• Financial performance depends on generic volume, low-cost production and supply reliability.
• Oral suspension may offer the clearest niche because it has greater manufacturing complexity and fewer dependable suppliers.
• Cefalexin, cefuroxime and amoxicillin-clavulanate impose sustained therapeutic and pricing pressure.
• Product-level revenue is generally not disclosed by public manufacturers.
• The most credible outlook is stable-to-declining revenue, with temporary upside possible during supply disruptions.

FAQs

Is cefaclor still sold in the United States?

Generic cefaclor products may remain available, but individual manufacturers, strengths and dosage forms can change. The original Ceclor brand is not the primary commercial source.

Can cefaclor be substituted automatically at the pharmacy?

Substitution depends on the specific FDA therapeutic-equivalence listing, state law, prescription requirements and the product dispensed. Pharmacists must follow applicable substitution rules.

Does cefaclor have a new-drug exclusivity period today?

No. Any original regulatory exclusivity associated with the innovator product expired decades ago.

Is cefaclor more profitable in oral suspension than capsules?

Potentially, but suspension products also carry higher stability, packaging and quality-control costs. Profitability depends on supply contracts, manufacturing scale and reimbursement.

Could cefaclor become a shortage-driven investment opportunity?

Only temporarily and selectively. A shortage can improve pricing, but substitution, regulatory intervention and new supply can quickly reduce the benefit. The product lacks the patent protection needed to sustain premium pricing.

References

1. U.S. Food and Drug Administration. (n.d.). Ceclor cefaclor prescribing information. FDA Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/

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

3. National Library of Medicine. (n.d.). Cefaclor drug label information. DailyMed. https://dailymed.nlm.nih.gov/dailymed/

4. U.S. Food and Drug Administration. (2019). Antimicrobial stewardship in outpatient settings. https://www.fda.gov/consumers/consumer-updates/combating-antibiotic-resistance

5. U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application process. https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda-generics