You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 12, 2025

CEFZIL Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Cefzil patents expire, and when can generic versions of Cefzil launch?

Cefzil is a drug marketed by Corden Pharma and is included in two NDAs.

The generic ingredient in CEFZIL is cefprozil. There are thirteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the cefprozil profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cefzil

A generic version of CEFZIL was approved as cefprozil by CHARTWELL RX on November 14th, 2005.

  Get Started Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for CEFZIL?
  • What are the global sales for CEFZIL?
  • What is Average Wholesale Price for CEFZIL?
Summary for CEFZIL
Drug patent expirations by year for CEFZIL
Recent Clinical Trials for CEFZIL

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

SponsorPhase
Ranbaxy Laboratories LimitedN/A
SandozPhase 1
Teva Pharmaceuticals USAPhase 1

See all CEFZIL clinical trials

US Patents and Regulatory Information for CEFZIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Corden Pharma CEFZIL cefprozil FOR SUSPENSION;ORAL 050665-001 Dec 23, 1991 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Corden Pharma CEFZIL cefprozil TABLET;ORAL 050664-002 Dec 23, 1991 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Corden Pharma CEFZIL cefprozil FOR SUSPENSION;ORAL 050665-002 Dec 23, 1991 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CEFZIL

Last updated: July 29, 2025

Introduction

Cefzil, with the generic name Cefprozil, is a second-generation cephalosporin antibiotic extensively used to treat bacterial infections, including pneumonia, ear infections, and pharyngitis. Since its initial approval, Cefzil has maintained relevance in both developed and emerging markets due to its efficacy, safety profile, and broad-spectrum activity. This article explores the market dynamics shaping Cefzil’s trajectory and projects its financial outlook amidst evolving healthcare trends, competitive landscape, and regulatory environments.

Market Overview and Key Applications

Cefzil primarily competes within the antibacterial agents market, a segment characterized by constant innovation and growing demand driven by the prevalence of infectious diseases. Its key applications span respiratory, otolaryngologic, and skin infections.

The global antibiotic market, valued at approximately USD 60 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 3-4% through 2027 [1]. Cefprozil, as a well-established second-generation cephalosporin, benefits from the increasing global burden of bacterial infections, especially in regions with limited access to advanced healthcare.

Market Dynamics

Driving Factors

  • Rising Incidence of Bacterial Infections: Increasing cases of respiratory and skin infections — exacerbated by urbanization, climate change, and antibiotic resistance — sustain demand for antibiotics like Cefzil.
  • Growing Healthcare Infrastructure: Expanding healthcare access in emerging markets fuels the consumption of established antibiotics, including Cefzil.
  • Patient Preference for Oral Antibiotics: Cefzil offers an oral formulation that improves compliance, especially in outpatient settings, reinforcing its position.
  • Established Efficacy and Safety Profile: Its longstanding use and broad-spectrum activity provide a competitive edge over newer agents with less extensive safety data.

Challenges and Constraints

  • Antibiotic Resistance: The global rise in resistant bacterial strains threatens Cefzil’s efficacy and market share. Regulatory agencies increasingly emphasize stewardship to limit overuse.
  • Generic Competition: As patent protections expire or are nonexistent, the entry of generic Cefprozil formulations significantly reduces pricing power.
  • Regulatory and Reimbursement Dynamics: Stringent regulatory requirements and variable reimbursement policies across countries influence market accessibility and profitability.
  • Shift Toward Narrow-Spectrum Agents: Emerging antibiotics with targeted activity and lower resistance potential could displace Cefzil in certain indications.

Competitive Landscape

Cefzil’s primary competitors include other second-generation cephalosporins, such as Cefuroxime, Cefaclor, and newer third-generation agents like Ceftriaxone, which offer broader spectra or injectable formulations. Pharmaceutical giants like GlaxoSmithKline and Apotex hold significant market shares in generic Cefprozil, while innovation-driven pharmaceutical companies explore next-generation broad-spectrum antibiotics.

Regulatory Environment

Regulatory agencies worldwide, notably the FDA and EMA, emphasize antimicrobial stewardship, affecting Cefzil's clinical use. As antimicrobial resistance (AMR) intensifies, regulatory bodies enforce stricter guidelines on prescriptions, potentially constraining volume but increasing the focus on appropriate use.

Financial Trajectory

Historical Financial Performance

Historically, Cefzil generated steady revenues within the antibiotics portfolio due to its strong efficacy record and widespread acceptance. However, revenues have plateaued or declined in mature markets due to patent expirations and generic competition. Gross margins for Cefzil typically hover in the 55-65% range, depending on manufacturing efficiency and regional pricing policies [2].

Projected Revenue Trends

  • Short-Term Outlook (1-3 years): The immediate outlook suggests stabilization or modest decline owing to generic erosion but may be offset by growth in emerging markets where brand loyalty persists. Initiatives such as strategic pricing and expanding indications can preserve revenue streams.
  • Medium to Long-Term Outlook (4-10 years): Demographic shifts, increased prevalence of respiratory infections, and expansion into underserved regions are expected to sustain demand. However, the impact of antimicrobial stewardship and resistance patterns could limit growth unless Cefzil's usage adapts to new clinical guidelines.

Pricing Strategies and Market Penetration

Pricing remains a pivotal factor. In developed markets, the presence of generic formulations exerts downward pressure. Nonetheless, targeted access programs, differentiated formulations, and co-marketing with diagnostic tools could bolster profitability. In contrast, emerging markets often maintain higher pricing levels due to limited generics and less aggressive price competition.

Investment and R&D Considerations

Given Cefzil's age as a mature product, R&D investments focus on developing novel formulations or combination therapies to extend lifecycle and improve compliance. The industry's trend towards precision medicine and rapid diagnostics suggests an imperative for integrating Cefzil into tailored treatment protocols, which could positively influence its financial trajectory.

Market Entry and Expansion Opportunities

  • Developing Countries: Rising infectious disease burdens and expanding healthcare infrastructure present opportunities for increased Cefzil adoption.
  • New Indications: Clinical research into Cefzil for off-label or new bacterial infections could unlock additional revenue streams.
  • Formulation Innovation: Developing pediatric-friendly formulations or combining Cefzil with other agents can expand market penetration.

Impact of External Factors on Financial Trajectory

Antimicrobial Stewardship

Global initiatives to curb antibiotic overuse threaten to diminish Cefzil’s prescription volume unless it adapts to stewardship principles—favoring targeted, short-course use, and promoting diagnostics to optimize therapy.

Regulatory Changes

Revisions to prescribing guidelines, stricter post-market surveillance, and approval delays in certain jurisdictions could impact revenue growth or result in market withdrawal.

Competitive Innovation

Emergence of new antibiotics with superior efficacy, safety, or resistance profiles could diminish Cefzil’s market viability. Conversely, strategic alliances or licensing deals could bolster financial returns.

Key Takeaways

  • Cefzil remains a relevant antibiotic within the evolving bacterial infection market, particularly in emerging markets, owing to its proven efficacy and safety.
  • Competition from generics and newer agents poses significant challenges; strategic pricing, formulation innovation, and targeted indications are essential to sustain profitability.
  • Antimicrobial stewardship and rising resistance levels necessitate adaptive clinical and market strategies to prevent decline.
  • The long-term financial outlook hinges on expansion efforts in untapped markets, development of new formulations, and alignment with evolving regulatory and stewardship frameworks.
  • Stakeholders must balance sustaining existing sales with innovation and compliance to optimize Cefzil’s market and financial position.

FAQs

1. What factors could impact Cefzil's market share in the upcoming years?

Antimicrobial resistance, generic competition, regulatory restrictions, and shifts in prescribing guidelines are primary factors that could diminish Cefzil's market share unless strategic countermeasures are implemented.

2. How do emerging markets influence Cefzil's financial outlook?

Growing healthcare infrastructure and infectious disease burdens in emerging markets provide opportunities for increased Cefzil utilization, often at higher pricing levels, positively influencing revenue growth.

3. Are there ongoing R&D efforts to revive the clinical utility of Cefzil?

Currently, most R&D focuses on novel formulations, combination therapies, or expanding indications, aiming to extend Cefzil’s lifecycle and adapt to regulatory and resistance challenges.

4. What role does antimicrobial stewardship play in Cefzil’s future?

Stewardship programs promote judicious use of antibiotics, potentially reducing Cefzil’s prescription volume. However, aligning with stewardship—such as targeted therapy—can help preserve its market relevance.

5. How can pharmaceutical companies leverage Cefzil amid a competitive landscape?

Enhancing formulations for better compliance, targeting underserved regions, collaborating with diagnostic platforms, and engaging in targeted marketing are key strategies to maintain competitiveness.


References:

[1] Grand View Research. “Antibiotics Market Size, Share & Trends Analysis Report, 2022-2027.”
[2] EvaluatePharma. “Global Antibiotics Market Data & Insights, 2022.”

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.