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Last Updated: December 22, 2024

Cephalexin hydrochloride - Generic Drug Details


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What are the generic drug sources for cephalexin hydrochloride and what is the scope of freedom to operate?

Cephalexin hydrochloride is the generic ingredient in one branded drug marketed by Lilly and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for cephalexin hydrochloride.

Summary for cephalexin hydrochloride
Recent Clinical Trials for cephalexin hydrochloride

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

SponsorPhase
Brett A FainePhase 4
Cairo UniversityPhase 4
St. Louis UniversityPhase 4

See all cephalexin hydrochloride clinical trials

US Patents and Regulatory Information for cephalexin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly KEFTAB cephalexin hydrochloride TABLET;ORAL 050614-001 Oct 29, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lilly KEFTAB cephalexin hydrochloride TABLET;ORAL 050614-002 Oct 29, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lilly KEFTAB cephalexin hydrochloride TABLET;ORAL 050614-003 May 16, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Cephalexin hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cephalexin Hydrochloride

Global Market Overview

The global cephalexin API market is poised for significant growth, driven by several key factors. As of 2024, the market size is estimated to be USD XX million and is expected to expand at a compound annual growth rate (CAGR) of 6.30% from 2024 to 2031[1].

Regional Market Analysis

North America

North America dominates the global cephalexin API market, holding around 40% of the global revenue. The region's advanced healthcare infrastructure, stringent regulatory standards, and emphasis on research and development are major drivers. The market in North America is projected to grow at a CAGR of 4.5% from 2024 to 2031. Injections are the leading segment here, due to their convenience and efficacy in delivering antibiotics[1].

Europe

Europe accounts for approximately 30% of the global market. The growing geriatric population, increased healthcare expenditure, and government initiatives to combat antimicrobial resistance are key growth drivers. The region's focus on healthcare quality and patient safety ensures consistent demand for high-quality APIs. Europe's market is expected to grow at a CAGR of 4.8% from 2024 to 2031[1].

Asia Pacific

Asia Pacific is a significant growth market, holding around 23% of the global revenue. Rapid urbanization, increasing incidence of bacterial infections, and the burgeoning pharmaceutical industry drive market growth here. The market in Asia Pacific is projected to grow at a CAGR of 8.3% from 2024 to 2031, with the powder injection segment being the fastest-growing due to its solubility, stability, and cost-effectiveness[1].

Latin America

Latin America accounts for about 5% of 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 contribute to market growth. The 99.5% purity segment dominates here due to its ease of administration and widespread availability[1].

Middle East and Africa

The Middle East and Africa hold around 2% of the global revenue and are expected to grow at a CAGR of 6.0% from 2024 to 2031. Increasing healthcare expenditure, government initiatives to improve healthcare access, and growing population drive the demand for cephalexin API in this region. The 99.5% purity segment is also dominant here due to its established reputation for quality and efficacy[1].

Market Segments

Formulations

The cephalexin API market is segmented into various formulations, with injections holding a prominent market share. This is due to their convenience and efficacy in delivering antibiotics, as well as advancements in injection technologies that enhance product stability and shelf life[1].

Purity Levels

The 99.5% purity segment is a significant player across various regions, including Europe, Latin America, and the Middle East and Africa. This segment benefits from stringent quality standards and regulatory compliance, as well as its ease of administration and widespread acceptance among healthcare professionals and patients[1].

Drivers of Market Growth

Increasing Bacterial Infections

The rising prevalence of bacterial infections requiring immediate and targeted treatment is a major driver for the cephalexin API market. This is particularly evident in regions like Asia Pacific, where rapid urbanization and increasing healthcare access contribute to higher incidences of bacterial infections[1].

Research and Development

Increasing research and development activities in the pharmaceutical sector, especially in regions like North America and Europe, drive innovation in drug formulations. Strategic collaborations between pharmaceutical companies and research institutions further stimulate market expansion[1].

Government Initiatives

Government initiatives to combat antimicrobial resistance and improve healthcare access are significant drivers. For instance, in Europe, these initiatives fuel market growth by ensuring consistent demand for high-quality APIs[1].

Advancements in Technology

Advancements in injection technologies and packaging enhance product stability and shelf life, further driving sales in the injection segment. This is particularly notable in North America, where such technologies are widely adopted[1].

Financial Trajectory

Market Size and Growth

The global cephalexin API market is expected to expand significantly, with a projected CAGR of 6.30% from 2024 to 2031. This growth is driven by the increasing demand for antibiotics, especially in regions with growing healthcare infrastructures and rising healthcare expenditures[1].

Regional Financial Performance

  • North America: Expected to grow at a CAGR of 4.5% from 2024 to 2031.
  • Europe: Expected to grow at a CAGR of 4.8% from 2024 to 2031.
  • Asia Pacific: Expected to grow at a CAGR of 8.3% from 2024 to 2031.
  • Latin America: Expected to grow at a CAGR of 5.7% from 2024 to 2031.
  • Middle East and Africa: Expected to grow at a CAGR of 6.0% from 2024 to 2031[1].

Cost and Pricing

Generic vs. Brand Name

Cephalexin is only available as a generic drug, which tends to be less expensive than brand-name medications. The cost can vary based on treatment plans, insurance coverage, and the pharmacy used[5].

Economic Evaluations

Economic evaluations of drug costs, such as those for cephalexin, often consider factors like mean, median, and variability in costs. For instance, previous research has provided base-case estimates and uncertainty ranges for cephalexin costs, which can help in financial planning and budgeting[3].

Industry Insights and Trends

Increasing Drug Approvals

Approvals and launches of novel cephalosporin drugs, such as ZERBAXA (ceftolozane and tazobactam), drive market growth. These approvals indicate a favorable environment for the development and use of cephalosporin antibiotics, including cephalexin[4].

Research and Development Activities

Clinical trials and research initiatives, like the one by B. Braun Medical Inc. on Cefazolin infusion, highlight the ongoing efforts to improve and expand the use of cephalosporin drugs. These activities are expected to create a favorable environment for market growth[4].

Restraints and Challenges

Antimicrobial Resistance

One of the significant challenges facing the cephalexin API market is the growing issue of antimicrobial resistance. This necessitates continuous innovation and the development of new antibiotics to combat resistant bacterial strains[4].

Regulatory Compliance

Stringent regulatory standards, while ensuring product quality, can also pose challenges for manufacturers. Compliance with these regulations is crucial but can be time-consuming and costly[1].

Key Takeaways

  • The global cephalexin API market is expected to grow at a CAGR of 6.30% from 2024 to 2031.
  • North America, Europe, and Asia Pacific are key regions driving market growth.
  • Injections and high-purity API segments are dominant due to their convenience, efficacy, and regulatory compliance.
  • Increasing bacterial infections, research and development, and government initiatives are major drivers.
  • The market faces challenges such as antimicrobial resistance and stringent regulatory compliance.

FAQs

What is the current market size of the global cephalexin API market?

The global cephalexin API market size is estimated to be USD XX million in 2024[1].

Which region dominates the global cephalexin API market?

North America dominates the global cephalexin API market, holding around 40% of the global revenue[1].

What is the expected CAGR for the cephalexin API market in Asia Pacific?

The cephalexin API market in Asia Pacific is expected to grow at a CAGR of 8.3% from 2024 to 2031[1].

Why are injections a prominent segment in the cephalexin API market?

Injections are favored for their convenience and efficacy in delivering antibiotics, as well as advancements in injection technologies that enhance product stability and shelf life[1].

How does the cost of cephalexin vary?

The cost of cephalexin can vary based on treatment plans, insurance coverage, and the pharmacy used. It is available only as a generic drug, which tends to be less expensive than brand-name medications[5].

Sources

  1. Cognitive Market Research: Cephalexin API Market Report 2024 (Global Edition)
  2. USITC: Generic Cephalexin Capsules from Canada
  3. PMC: US-based Drug Cost Parameter Estimation for Economic Evaluations
  4. Coherent Market Insights: Cephalosporin Drugs Market - Share, Size and Industry Analysis
  5. MedicalNewsToday: Cephalexin cost 2024: Coupons and more

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