CEPHALEXIN - Generic Drug Details

What are the generic sources for cephalexin and what is the scope of patent protection?

Cephalexin is the generic ingredient in five branded drugs marketed by Alkem Labs Ltd, Anda Repository, Apothecon, Aurobindo Pharma, Barr, Belcher Pharms, Chartwell Rx, Facta Farma, Hikma, Ivax Sub Teva Pharms, Lupin, Purepac Pharm, Stevens J, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Teva, Yoshitomi, Pragma, Hikma Pharms, Vitarine, Yung Shin Pharm, Ranbaxy Labs Ltd, Aurobindo Pharma Ltd, and Lilly, and is included in fifty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for cephalexin. Thirty-eight suppliers are listed for this compound.

Summary for CEPHALEXIN

US Patents:	0
Tradenames:	5
Applicants:	24
NDAs:	58
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	64
Patent Applications:	7,462
Drug Prices:	Drug price trends for CEPHALEXIN
Drug Sales Revenues:	Drug sales revenues for CEPHALEXIN
What excipients (inactive ingredients) are in CEPHALEXIN?	CEPHALEXIN excipients list
DailyMed Link:	CEPHALEXIN at DailyMed

See drug prices for CEPHALEXIN

See drug sales revenues for CEPHALEXIN

Recent Clinical Trials for CEPHALEXIN

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

Sponsor	Phase
Brett A Faine	Phase 4
Cairo University	Phase 4
St. Louis University	Phase 4

See all CEPHALEXIN clinical trials

Pharmacology for CEPHALEXIN

Drug Class

Cephalosporin Antibacterial

Medical Subject Heading (MeSH) Categories for CEPHALEXIN

Anti-Bacterial Agents

US Patents and Regulatory Information for CEPHALEXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	CEPHALEXIN	cephalexin	CAPSULE;ORAL	065253-003	Dec 6, 2023	AB	RX	No	No
Vitarine	CEPHALEXIN	cephalexin	TABLET;ORAL	062863-001	Aug 11, 1988		DISCN	No	No
Teva	CEPHALEXIN	cephalexin	FOR SUSPENSION;ORAL	062768-001	Jun 16, 1987		DISCN	No	No
Sun Pharm Inds Ltd	CEPHALEXIN	cephalexin	FOR SUSPENSION;ORAL	065081-001	Jul 27, 2001		DISCN	No	No
Lilly	KEFTAB	cephalexin hydrochloride	TABLET;ORAL	050614-002	Oct 29, 1987		DISCN	No	No
Teva	CEPHALEXIN	cephalexin	FOR SUSPENSION;ORAL	062873-001	May 23, 1988		DISCN	No	No

CEPHALEXIN Market Analysis and Financial Projection Experimental

Cephalexin Market Dynamics and Financial Trajectory

Market Introduction

Cephalexin, a first-generation cephalosporin antibiotic, is widely used to treat various bacterial infections, including respiratory tract infections, skin and skin structure infections, bone infections, and genitourinary infections. It is also used to prevent endocarditis caused by bacterial infections[4].

Global Market Size and Growth

The global cephalexin API market is projected to expand significantly over the next few years. As of 2024, the market size is estimated to be USD XX million and is expected to grow at a compound annual growth rate (CAGR) of 6.30% from 2024 to 2031[1].

Regional Market Analysis

North America

North America holds a dominant position in the global cephalexin API market, accounting for around 40% of the global revenue. The region's stringent regulatory standards, emphasis on research and development, and strategic collaborations between pharmaceutical companies and research institutions drive market growth. The injection segment is particularly prominent due to its convenience and efficacy[1].

Europe

Europe accounts for approximately 30% of the global market size. The growing geriatric population, increased healthcare expenditure, and government initiatives to combat antimicrobial resistance are key drivers. The region's focus on healthcare quality and patient safety ensures consistent demand for high-quality APIs. The 99.5% purity segment holds the highest market share due to its ease of administration and regulatory compliance[1].

Latin America

Latin America contributes around 5% to the global revenue and is expected to grow at a CAGR of 5.7% from 2024 to 2031. The region's expanding healthcare infrastructure, rising awareness of infectious diseases, and favorable regulatory environment are significant factors. The 99.5% purity segment dominates due to its ease of administration and widespread availability[1].

Middle East and Africa

The Middle East and Africa region holds around 2% of the global market share and is projected to grow at a CAGR of 6.0% from 2024 to 2031. Increasing healthcare expenditure, government initiatives, and collaborations between pharmaceutical companies and healthcare organizations drive market expansion. The 99.5% purity segment is preferred for its established reputation for quality and efficacy[1].

Market Drivers

Increasing Prevalence of Bacterial Infections

The rising incidence of bacterial infections such as pneumonia, urinary tract infections, skin infections, and meningitis is a major driver. Cephalosporins, including cephalexin, are crucial in treating these infections due to their broad-spectrum activity and efficacy[3].

Advancements in Antibiotic Research

Continuous efforts in research and development to create more effective and resistant-free cephalosporins enhance the market's growth prospects. Innovations in drug formulations and delivery methods, such as advanced injection technologies, further support market expansion[3].

Healthcare Expenditure and Government Initiatives

Increasing healthcare expenditure and government initiatives to combat antimicrobial resistance and improve healthcare access are significant drivers. These initiatives often include funding for research, improving regulatory frameworks, and promoting the use of high-quality APIs[1][3].

Market Challenges

Cost Pressures and Pricing Flexibility

Cost pressures within healthcare systems pose a significant challenge. Pharmaceutical firms face pressure to lower drug prices and offer cost-effective treatments, limiting pricing flexibility and impacting profitability and research investments. Payer negotiations and reimbursement constraints exacerbate these challenges[1].

Availability and Accessibility

The availability of cephalexin in emerging nations is anticipated to hamper market growth. Limited access to healthcare facilities and economic constraints in these regions affect the demand for cephalexin[4].

Market Segmentation

By Formulation

The global cephalexin market is segmented into capsules, liquid suspension, and tablets. Each formulation has its own market share and growth prospects, with the injection segment being particularly prominent in regions like North America due to its convenience and efficacy[4].

By Distribution Channel

The market is segmented into retail pharmacies, online pharmacies, and hospital pharmacies. Hospital pharmacies often dominate due to the high demand for antibiotics in hospital settings[4].

Key Players and Strategies

Companies such as Lupin Pharmaceuticals Inc, PRAGMA, ALKEM LABS LTD, AUROBINDO PHARMA LTD, Hikma Pharmaceuticals PLC, Teva Pharmaceutical Industries Ltd, and Yung Shin Pharmaceutical Industrial Co are key players in the cephalexin market. These companies focus on strategy building models to strengthen their product portfolios and expand their business globally. Strategic collaborations and investments in R&D are common strategies to maintain market competitiveness[4].

Financial Trajectory

The financial trajectory of the cephalexin market is positive, driven by the growing demand for antibiotics and advancements in pharmaceutical technologies. Here are some key financial indicators:

• Global Market Size: Estimated at USD XX million in 2024, expected to grow at a CAGR of 6.30% from 2024 to 2031[1].
• Regional Growth: North America is expected to grow at a CAGR of 4.5%, Europe at 4.8%, Latin America at 5.7%, and the Middle East and Africa at 6.0% during the forecast period[1].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the cephalexin market. While it has accelerated the need for effective antibiotics due to secondary bacterial infections in COVID-19 patients, it has also disrupted supply chains and affected production capacities. However, the long-term growth prospects remain robust due to the ongoing need for antibiotics in treating various bacterial infections[5].

Key Takeaways

• The global cephalexin API market is expected to grow significantly, driven by increasing bacterial infections and advancements in antibiotic research.
• Regional markets such as North America, Europe, and Latin America are key contributors to the global market.
• Cost pressures and limited availability in emerging nations are significant challenges.
• Strategic collaborations and investments in R&D are crucial for market competitiveness.
• The market is segmented by formulation and distribution channel, with the injection segment and hospital pharmacies being prominent.

FAQs

Q: What is the expected CAGR of the global cephalexin API market from 2024 to 2031? A: The global cephalexin API market is expected to grow at a CAGR of 6.30% from 2024 to 2031[1].

Q: Which region holds the largest market share in the global cephalexin API market? A: North America holds around 40% of the global revenue and is the largest market for cephalexin API[1].

Q: What are the main drivers of the cephalexin market? A: The main drivers include the increasing prevalence of bacterial infections, advancements in antibiotic research, and increasing healthcare expenditure and government initiatives[1][3].

Q: Which formulation segment dominates the cephalexin market? A: The injection segment, particularly the 99.5% purity segment, dominates the market due to its convenience and efficacy[1][2].

Q: How has the COVID-19 pandemic impacted the cephalexin market? A: The pandemic has accelerated the need for effective antibiotics but has also disrupted supply chains and affected production capacities. Long-term growth prospects remain robust[5].

Sources:

1. Cognitive Market Research - Cephalexin API Market Report 2024 (Global Edition)
2. Cognitive Market Research - Cefalexin API Market Report 2024 (Global Edition)
3. Data Bridge Market Research - Global Cephalosporin Market – Industry Trends and Forecast to 2031
4. The Insight Partners - Cephalexin Market Updates by 2031
5. Stratview Research - Cephalosporin Market Size, Share, & Growth Analysis