Cefaclor - Generic Drug Details

What are the generic sources for cefaclor and what is the scope of freedom to operate?

Cefaclor is the generic ingredient in four branded drugs marketed by Lilly, Ceph Intl, Chartwell Rx, Dava Pharms Inc, Hikma, Ivax Sub Teva Pharms, Ranbaxy, Teva, Yung Shin Pharm, Facta Farma, Watson Labs Inc, Ranbaxy Labs Ltd, and World Gen, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for cefaclor. Four suppliers are listed for this compound.

Summary for cefaclor

US Patents:	0
Tradenames:	4
Applicants:	13
NDAs:	33
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	4
Drug Prices:	Drug price trends for cefaclor
What excipients (inactive ingredients) are in cefaclor?	cefaclor excipients list
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
James Graham Brown Cancer Center	Early Phase 1
Julio Ramirez	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
Lilly	CECLOR	cefaclor	FOR SUSPENSION;ORAL	050522-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Ranbaxy Labs Ltd	RANICLOR	cefaclor	TABLET, CHEWABLE;ORAL	065092-002	Dec 22, 2003		DISCN	No	No

Cefaclor Market Analysis and Financial Projection

Last updated: February 13, 2026

What are the current market dynamics for Cefaclor?

Cefaclor is a second-generation cephalosporin antibiotic used primarily to treat bacterial infections such as respiratory tract infections, skin infections, and urinary tract infections. The global market for cefaclor and similar antibiotics is driven by increasing bacterial resistance, rising prevalence of respiratory and urinary infections, and expanding healthcare infrastructure in emerging markets.

Drivers and constraints

• Growing infectious disease burden: Incidence of pneumonia, bronchitis, and urinary tract infections fuels demand for cephalosporins, including cefaclor. The World Health Organization (WHO) reports a consistent rise in bacterial infections worldwide.
• Antibiotic resistance concerns: The escalation of resistant strains creates demand for newer or alternative antibiotics but also prompts recall or restriction of certain drugs, impacting market stability.
• Shifts toward generic drugs: Patent expirations have increased availability of generic cefaclor, lowering prices and expanding access in cost-sensitive regions.
• Regulatory environment: Stringent approval processes and concerns over antimicrobial resistance influence market entry and drug approval rates. Agencies like the FDA and EMA frequently update guidelines for antibiotic use.
• Competitive landscape: Dominated by generic manufacturers in Asia, with a few branded players active in North America and Europe. Market share shifts toward lower-cost generics influence pricing strategies and profitability.

Market size and segmentation

• The global antibiotics market was valued at approximately USD 53 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 3-4% through 2030.
• Cefaclor constitutes an estimated 5% of the second-generation cephalosporin segment, valued at roughly USD 1.5 billion globally.
• Geographically, Asia Pacific accounts for approximately 45% of the cefaclor market, driven by large populations and expanding healthcare systems. North America and Europe combined contribute around 40%, with the remainder in Latin America and Africa.
• Distribution channels include hospital pharmacies (60%), retail pharmacies (30%), and direct dispensing via clinics.

How does the financial trajectory look for cefaclor?

Revenue trends

• Historical revenues: Leading generic producers have reported steady revenues, with annual sales ranging from USD 100-200 million for their cefaclor portfolios.
• Pricing trends: Average retail price per 250 mg capsule declined by 15% from 2019 to 2022, consistent with generic market trends.
• Market forecasts: Growth in demand for cefaclor is expected to continue modestly due to increased bacterial infections but may face downward pressure from antimicrobial stewardship efforts.

Cost structure and profitability

• Manufacturing costs: Estimated at USD 0.10-0.20 per capsule, including raw materials, labor, and quality control.
• Pricing: Wholesale prices hover around USD 0.30-0.50 per capsule in many regions.
• Margins: Gross margins for generic manufacturers are approximately 40-50%, with net margins around 10-15% due to marketing and regulatory expenses.

R&D investment outlook

• R&D expenditure for cephalosporins has decreased, with most investment directed toward novel antibiotics rather than established drugs like cefaclor.
• Patent expirations on older formulations have resulted in reduced R&D overheads but increased focus on biosimilars and combination therapies.

Regulatory and patent landscape

• Cefaclor is off-patent worldwide; recent patent expirations (e.g., in the U.S. in 2015) have enhanced generic competition.
• Ongoing regulatory reviews in different regions influence market access, especially concerning antimicrobial stewardship policies.

Risks impacting financial trajectory

• Antibiotic resistance: May reduce efficacy, leading to decreased prescribing and revenues.
• Regulatory restrictions: Stricter antimicrobial use guidelines reduce sales volume.
• Market saturation: High levels of generic competition limit pricing power and profit margins.
• Supply chain disruptions: Raw material shortages can increase manufacturing costs.

What are the key takeaways?

• The cefaclor market is stable but mature, driven by demand for antibiotics in bacterial infection treatment.
• Market growth remains modest, constrained by generic competition, pricing pressures, and stewardship policies.
• Revenue and profitability are sensitive to regional regulatory changes and resistance trends.
• Manufacturing costs are low, supporting narrow margins.
• Investment is concentrated in newer antibiotics, with limited R&D focus on cefaclor.

What are five frequently asked questions?

1. How does resistance development affect cefaclor’s market?
Resistance reduces clinical effectiveness, decreasing prescription rates and sales over time. Stewardship campaigns aim to minimize unnecessary antibiotic use, further impacting demand.

2. Are there new formulations or combinations in development?
Current innovation focuses on combination therapies rather than new cefaclor formulations, with limited pipeline activity. Development is hampered by regulatory challenges and the focus on novel antibiotics.

3. How does regional regulation influence cefaclor sales?
Strict antimicrobial guidelines in regions like the EU and US restrict use to specific indications, reducing the volume of prescriptions. Conversely, emerging markets may have more lenient policies, supporting volume growth.

4. What is the impact of generic pharmaceutical companies on cefaclor?
They dominate supply, driving prices down and widening access. This proliferation limits profit margins for branded manufacturers and discourages large R&D investments.

5. Is cefaclor likely to be replaced by newer antibiotics?
Yes, especially if resistance diminishes drug efficacy or if stewardship policies restrict its use. However, it remains a cost-effective option for specific indications, thus maintaining some market relevance.

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Sources

[1] MarketsandMarkets. "Antibiotics Market," 2022.
[2] WHO. "Global Burden of Bacterial Infections," 2021.
[3] EvaluatePharma. "Pharmaceutical Market Data," 2023.
[4] FDA and EMA approval guidelines, 2022.