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
Patent Applications:	7,182
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
University of Louisville	Early Phase 1
James Graham Brown Cancer Center	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
Teva	CEFACLOR	cefaclor	CAPSULE;ORAL	064081-001	Sep 16, 1996		DISCN	No	No
Ranbaxy	CEFACLOR	cefaclor	CAPSULE;ORAL	064156-002	Aug 28, 1997		DISCN	No	No
Ceph Intl	CEFACLOR	cefaclor	CAPSULE;ORAL	062205-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Lilly	CECLOR	cefaclor	FOR SUSPENSION;ORAL	050522-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Ranbaxy	CEFACLOR	cefaclor	CAPSULE;ORAL	064156-001	Aug 28, 1997		DISCN	No	No
Watson Labs Inc	CEFACLOR	cefaclor	FOR SUSPENSION;ORAL	064207-001	Feb 18, 1998		DISCN	No	No
Dava Pharms Inc	CEFACLOR	cefaclor	FOR SUSPENSION;ORAL	064110-001	Apr 28, 1995		DISCN	No	No

Cefaclor Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cefaclor

Overview of Cefaclor Market

Cefaclor, a second-generation cephalosporin antibiotic, is widely used to treat various bacterial infections, including pneumonia, otitis media, skin infections, and urinary tract infections. Here’s a detailed look at the market dynamics and financial trajectory of Cefaclor.

Global Market Size and Growth

As of 2024, the global Cefaclor market size is estimated to be USD 162.5 million[1][4].

• This market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.50% from 2024 to 2031, reaching USD 221.1 million by 2031[1].

Regional Market Breakdown

North America

• North America holds the largest share of the global Cefaclor market, with a market size of USD 65 million in 2024.
• The region is expected to grow at a CAGR of 2.7% from 2024 to 2031[1].

Europe

• Europe accounts for more than 30% of the global revenue, with a market size of USD 48.75 million in 2024.
• The European market is forecasted to grow at a CAGR of 3.0% from 2024 to 2031[1].

Asia Pacific

• The Asia Pacific region holds around 23% of the global revenue, with a market size of USD 37.38 million in 2024.
• This region is expected to exhibit the highest growth rate, with a CAGR of 6.5% from 2024 to 2031, driven by increasing healthcare expenditure and a burgeoning population, especially in China and India[1][3].

Latin America and Middle East & Africa

• Latin America accounts for more than 5% of the global revenue, with a market size of USD 8.13 million in 2024, and is expected to grow at a CAGR of 3.9% from 2024 to 2031.
• The Middle East and Africa hold around 2% of the global revenue, with a market size of USD 3.25 million in 2024, and are forecasted to grow at a CAGR of 4.2% from 2024 to 2031[1].

Key Drivers of Market Growth

Increasing Prevalence of Bacterial Infections

• The rising incidence of bacterial infections globally is a significant driver for the Cefaclor market. As bacterial infections continue to be a major health concern, the demand for effective antibiotics like Cefaclor is expected to increase[1][3][4].

Advancements in Pharmaceutical Research and Development

• Continuous advancements in pharmaceutical research and development, including the creation of new formulations and delivery systems, are boosting the market growth. These innovations enhance the efficacy and convenience of Cefaclor, making it more appealing to both healthcare providers and patients[3].

Growing Healthcare Expenditure

• Increasing healthcare expenditure, particularly in emerging markets, is another key factor driving the growth of the Cefaclor market. As healthcare infrastructure improves and more people gain access to medical services, the demand for antibiotics like Cefaclor increases[3].

Challenges and Barriers

Development of Antibiotic Resistance

• One of the major challenges facing the Cefaclor market is the development of antibiotic resistance. As bacteria become more resistant to antibiotics, the effectiveness of Cefaclor and other antibiotics may decrease, posing a significant threat to market growth[3].

Stringent Regulatory Requirements

• The pharmaceutical industry is heavily regulated, and stringent regulatory requirements can pose barriers to market entry and growth. High costs associated with clinical trials, regulatory compliance, and marketing can be particularly challenging for smaller companies[1].

Emergence of Alternative Treatment Options

• The emergence of alternative treatment options, such as new antibiotics or non-antibiotic treatments, can also impact the market for Cefaclor. These alternatives may offer better efficacy or fewer side effects, potentially reducing the demand for Cefaclor[3].

Market Opportunities

New Formulation Developments

• The development of new formulations of Cefaclor, such as extended-release versions or combination therapies, presents significant opportunities for market growth. These new formulations can enhance patient compliance and treatment outcomes[3].

Expansion in Emerging Markets

• The expansion into emerging markets, particularly in the Asia Pacific region, offers substantial growth opportunities. Increasing healthcare expenditure and a growing population in these regions are expected to drive the demand for Cefaclor[1][3].

Increasing Investment in Healthcare Infrastructure

• Investments in healthcare infrastructure, especially in developing countries, are expected to increase access to medical services and drive the demand for antibiotics like Cefaclor[3].

Competitive Landscape

The Cefaclor market is competitive, with several key players including Union Chempharma, NCPC, Qilu Antibiotics, Lupin Pharmaceuticals, and others. These companies are involved in continuous research and development to improve the efficacy and delivery of Cefaclor, as well as expanding their market presence in various regions[4].

Financial Trajectory

Revenue Forecast

• The global Cefaclor market is expected to grow from USD 162.5 million in 2024 to USD 221.1 million by 2031, at a CAGR of 4.50%[1].

Regional Revenue Growth

• North America: USD 65 million in 2024, growing at a CAGR of 2.7% from 2024 to 2031.
• Europe: USD 48.75 million in 2024, growing at a CAGR of 3.0% from 2024 to 2031.
• Asia Pacific: USD 37.38 million in 2024, growing at a CAGR of 6.5% from 2024 to 2031[1].

Conclusion

The Cefaclor market is poised for steady growth driven by increasing bacterial infections, advancements in pharmaceutical research, and growing healthcare expenditure. However, challenges such as antibiotic resistance and stringent regulatory requirements need to be addressed. The market's financial trajectory indicates a promising future, especially in emerging markets, where new formulation developments and investments in healthcare infrastructure are expected to play a crucial role.

Key Takeaways

• Global Market Size: USD 162.5 million in 2024, expected to reach USD 221.1 million by 2031.
• CAGR: 4.50% from 2024 to 2031.
• Regional Growth: North America, Europe, and Asia Pacific are key regions, with Asia Pacific showing the highest growth rate.
• Drivers: Increasing bacterial infections, advancements in pharmaceutical research, and growing healthcare expenditure.
• Challenges: Antibiotic resistance, stringent regulatory requirements, and emergence of alternative treatments.
• Opportunities: New formulation developments, expansion in emerging markets, and increasing investment in healthcare infrastructure.

FAQs

What is the current global market size of Cefaclor?

The global Cefaclor market size is estimated to be USD 162.5 million in 2024[1].

What is the projected growth rate of the Cefaclor market from 2024 to 2031?

The Cefaclor market is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.50% from 2024 to 2031[1].

Which region holds the largest share of the global Cefaclor market?

North America holds the largest share of the global Cefaclor market, with a market size of USD 65 million in 2024[1].

What are the key drivers of the Cefaclor market growth?

Key drivers include the increasing prevalence of bacterial infections, advancements in pharmaceutical research and development, and growing healthcare expenditure[1][3][4].

What are the major challenges facing the Cefaclor market?

Major challenges include the development of antibiotic resistance, stringent regulatory requirements, and the emergence of alternative treatment options[3].

Which companies are key players in the Cefaclor market?

Key players include Union Chempharma, NCPC, Qilu Antibiotics, Lupin Pharmaceuticals, and others[4].

Sources

1. Cognitive Market Research: Global Cefaclor Market Report 2024.
2. OpenPR: Cefaclor Market: What are the best suggestions to maintain.
3. 360iResearch: Cefaclor Market by Type, Spectrum Activity, Formulation, Application.
4. Valuates Reports: Cefaclor - Market, Report Size, Worth, Revenue, Growth, Industry.