Last Updated: April 24, 2026

CEFADROXIL Drug Patent Profile


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Which patents cover Cefadroxil, and what generic alternatives are available?

Cefadroxil is a drug marketed by Aurobindo Pharma, Chartwell Rx, Cspc Ouyi, Hikma, Ivax Sub Teva Pharms, Lupin, Purepac Pharm, Ranbaxy Labs Ltd, Sandoz, Teva, Teva Pharms, Ani Pharms, Apothecon, Aurobindo, Hikma Pharms, Sun Pharm Inds Ltd, and Ranbaxy. and is included in twenty-three NDAs.

The generic ingredient in CEFADROXIL is cefadroxil/cefadroxil hemihydrate. Nineteen suppliers are listed for this compound. Additional details are available on the cefadroxil/cefadroxil hemihydrate profile page.

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Recent Clinical Trials for CEFADROXIL

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SponsorPhase
Hasanuddin UniversityPhase 4
Rothman Institute OrthopaedicsPhase 3
University of Colorado, DenverPhase 1

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Pharmacology for CEFADROXIL

US Patents and Regulatory Information for CEFADROXIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma CEFADROXIL cefadroxil/cefadroxil hemihydrate TABLET;ORAL 065260-001 Mar 30, 2006 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sun Pharm Inds Ltd CEFADROXIL cefadroxil/cefadroxil hemihydrate FOR SUSPENSION;ORAL 065115-001 Mar 26, 2003 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ranbaxy CEFADROXIL cefadroxil/cefadroxil hemihydrate TABLET;ORAL 065018-001 Apr 23, 1999 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sun Pharm Inds Ltd CEFADROXIL cefadroxil/cefadroxil hemihydrate FOR SUSPENSION;ORAL 065115-002 Mar 26, 2003 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Aurobindo Pharma CEFADROXIL cefadroxil/cefadroxil hemihydrate CAPSULE;ORAL 065352-001 Jan 25, 2007 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Cefadroxil: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is Cefadroxil and its Therapeutic Use?

Cefadroxil is a first-generation cephalosporin antibiotic used to treat a variety of bacterial infections. It is effective against Gram-positive and some Gram-negative bacteria. Its primary applications include the treatment of skin and soft tissue infections, urinary tract infections, and pharyngitis. Cefadroxil functions by inhibiting bacterial cell wall synthesis, leading to cell lysis and death [1].

What is the Current Market Size and Growth Projection for Cefadroxil?

The global cefadroxil market size was valued at approximately $450 million in 2023 [2]. Market growth is projected at a compound annual growth rate (CAGR) of 3.5% from 2024 to 2030 [2]. This moderate growth is influenced by consistent demand for affordable and effective antibiotics, alongside the increasing prevalence of bacterial infections in specific demographics.

Cefadroxil Market Share by Region (2023)

Region Market Value (USD Million) Percentage Share
North America 120 26.7%
Europe 105 23.3%
Asia Pacific 140 31.1%
Latin America 50 11.1%
Middle East & Africa 35 7.8%

Source: Internal analysis based on industry reports.

The Asia Pacific region holds the largest market share due to a larger patient pool, rising healthcare expenditures, and a higher incidence of infectious diseases [3]. North America and Europe follow, driven by established healthcare systems and an aging population prone to infections.

What are the Key Factors Driving Cefadroxil Market Growth?

Several factors contribute to the sustained demand and growth of the cefadroxil market.

Prevalence of Bacterial Infections

  • Urinary Tract Infections (UTIs): UTIs are a common indication for cefadroxil, particularly in women. The high recurrence rate of UTIs globally sustains demand for effective treatment options [4].
  • Skin and Soft Tissue Infections (SSTIs): Cefadroxil is a first-line treatment for uncomplicated SSTIs like impetigo and cellulitis. The incidence of these infections remains significant across all age groups [5].
  • Pharyngitis: While often viral, bacterial pharyngitis, particularly streptococcal, requires antibiotic treatment. Cefadroxil is an option for susceptible strains [6].

Cost-Effectiveness and Accessibility

  • Generic Availability: Cefadroxil is a well-established drug with numerous generic manufacturers. This leads to lower pricing compared to newer antibiotics, making it accessible to a broader patient population, especially in low- and middle-income countries [7].
  • Established Treatment Guidelines: Cefadroxil is frequently included in national and international treatment guidelines for common bacterial infections due to its efficacy and safety profile for specific indications [8].

Pediatric Use

  • Pediatric Applications: Cefadroxil is often prescribed for bacterial infections in children, including otitis media and pharyngitis, where it offers a favorable safety profile and palatable formulations (e.g., oral suspensions) [9].

What are the Restraining Factors for Cefadroxil Market Growth?

Despite its advantages, the cefadroxil market faces several constraints.

Antibiotic Resistance

  • Growing Resistance: The emergence and spread of antibiotic-resistant bacteria pose a significant threat. While first-generation cephalosporins like cefadroxil retain efficacy against many common pathogens, resistance patterns are evolving, potentially limiting its utility for certain infections over time [10].
  • Spectrum Limitations: Cefadroxil has a narrow spectrum of activity compared to later-generation cephalosporins and other antibiotic classes, making it unsuitable for treating infections caused by a wider range of pathogens or more resistant strains [1].

Availability of Newer Antibiotics

  • Advanced Therapies: The development of newer antibiotics with broader spectra, improved pharmacokinetic profiles, or novel mechanisms of action can displace older drugs like cefadroxil for specific indications or in healthcare settings where advanced treatments are prioritized [11].
  • Empirical Treatment Shifts: In some regions or for severe infections, clinicians may opt for broader-spectrum empirical therapy to cover a wider range of potential pathogens, bypassing cefadroxil as a first choice [12].

Regulatory Scrutiny and Market Exclusivity

  • Generic Competition: The high degree of generic competition intensifies price pressures and limits the potential for significant revenue growth for individual manufacturers. Patent expiries for original cefadroxil formulations have long passed [13].
  • Stewardship Programs: Increasing emphasis on antibiotic stewardship programs may lead to more judicious use of antibiotics, potentially reducing overall consumption of older, broad-spectrum agents where alternatives exist [14].

What is the Competitive Landscape for Cefadroxil?

The cefadroxil market is highly fragmented, characterized by the presence of numerous generic manufacturers. Competition is primarily driven by price, product quality, and supply chain reliability.

Major Manufacturers and Their Market Presence

  • Teva Pharmaceutical Industries Ltd.: A leading generic pharmaceutical company with a significant global presence in antibiotic manufacturing.
  • Sun Pharmaceutical Industries Ltd.: A major Indian pharmaceutical company with a robust portfolio of generic antibiotics, including cefadroxil.
  • Cipla Ltd.: Another prominent Indian pharmaceutical company that supplies cefadroxil to various international markets.
  • Lupin Ltd.: A global pharmaceutical company with a strong focus on generics and established manufacturing capabilities for cephalosporins.
  • Dr. Reddy's Laboratories Ltd.: An Indian multinational pharmaceutical company involved in the manufacturing and distribution of cefadroxil.

These companies, along with many smaller regional players, compete on price and distribution networks. The emphasis is on efficient production and large-volume sales.

What are the Key Patent and Intellectual Property Considerations for Cefadroxil?

Cefadroxil is an off-patent drug. The original patents protecting its synthesis and formulation have long expired. Consequently, there is no active patent protection for the core cefadroxil molecule that would grant market exclusivity for manufacturers.

  • Exclusivity Period: N/A (Off-patent)
  • Patent Expiry: The foundational patents for cefadroxil expired in the late 20th century.
  • Innovation Focus: Current intellectual property activity, if any, is likely focused on novel delivery systems, combination therapies, or manufacturing process improvements, none of which grant broad market exclusivity for the drug itself.

The absence of patent protection means that any company can manufacture and sell generic cefadroxil, leading to an intensely competitive market driven by manufacturing costs and market access.

What is the Financial Trajectory and Profitability Outlook for Cefadroxil Manufacturers?

The financial trajectory for cefadroxil manufacturers is characterized by steady but moderate revenue streams and tight profit margins.

  • Revenue Drivers: Revenue is primarily driven by volume sales and established contracts with distributors and healthcare providers. Growth is incremental, tied to overall market expansion and healthcare access.
  • Profit Margins: Profit margins are typically low due to intense generic competition and price erosion. Manufacturers achieve profitability through economies of scale, efficient production processes, and optimized supply chain management.
  • Investment Focus: Investment for manufacturers is directed towards cost optimization, capacity expansion to meet high-volume demand, and maintaining high-quality manufacturing standards to meet regulatory requirements. Research and development expenditure on cefadroxil itself is minimal, given its off-patent status.

The financial outlook remains stable, with growth tied to global healthcare trends rather than novel product launches or market disruptions.

Key Takeaways

  • Cefadroxil is a widely used, first-generation cephalosporin antibiotic with a global market valued at approximately $450 million in 2023.
  • The market is projected to grow at a CAGR of 3.5% between 2024 and 2030, driven by the persistent prevalence of common bacterial infections and its cost-effectiveness.
  • Key drivers include the high incidence of UTIs, SSTIs, and pediatric infections, coupled with its generic availability and inclusion in treatment guidelines.
  • Restraining factors include the increasing threat of antibiotic resistance, limitations in its spectrum of activity, and competition from newer antibiotic classes.
  • The cefadroxil market is highly fragmented and competitive, dominated by generic manufacturers who compete on price and supply chain efficiency.
  • Cefadroxil is an off-patent drug, meaning there is no active patent protection. Intellectual property activity is limited to process improvements or novel formulations rather than the core drug.
  • Financial trajectories for manufacturers show steady but low-margin revenue, emphasizing scale and efficiency for profitability.

Frequently Asked Questions

What are the most common side effects of cefadroxil?

The most common side effects of cefadroxil include nausea, vomiting, diarrhea, and rash. Allergic reactions can also occur [15].

How does cefadroxil compare to other first-generation cephalosporins like cephalexin?

Cefadroxil and cephalexin are both first-generation cephalosporins with similar spectra of activity and common indications. Cefadroxil typically has a longer half-life, allowing for less frequent dosing (once or twice daily) compared to cephalexin (four times daily) [16].

Can cefadroxil be used to treat severe bacterial infections?

Cefadroxil is generally recommended for the treatment of mild to moderate bacterial infections. For severe or systemic infections, broader-spectrum or later-generation antibiotics are often preferred [1].

What is the typical duration of a cefadroxil prescription?

The duration of cefadroxil treatment varies depending on the type and severity of the infection. It typically ranges from 7 to 14 days [17].

Is cefadroxil effective against MRSA (Methicillin-resistant Staphylococcus aureus)?

Cefadroxil is generally not effective against MRSA infections. MRSA strains typically exhibit resistance to beta-lactam antibiotics, including first-generation cephalosporins [18].

Citations

[1] Lexicomp. (n.d.). Cefadroxil. Retrieved from [Lexicomp database access] [2] Grand View Research. (2023). Cefadroxil Market Size, Share & Trends Analysis Report. [3] Fortune Business Insights. (2023). Cefadroxil Market Size, Share & COVID-19 Impact Analysis. [4] National Institute of Diabetes and Digestive and Kidney Diseases. (2022). Urinary Tract Infections in Adults. [5] American Academy of Dermatology Association. (n.d.). Cellulitis. [6] Infectious Diseases Society of America. (2012). Clinical Practice Guidelines for the Diagnosis and Management of Group A Streptococcal Pharyngitis. [7] World Health Organization. (2020). Antibiotic resistance: What can patients do? [8] NICE. (2021). Urinary tract infection (lower): antimicrobial prescribing. [9] American Academy of Pediatrics. (2022). Red Book: Report of the Committee on Infectious Diseases. [10] Centers for Disease Control and Prevention. (2023). Antibiotic Resistance Threats in the United States. [11] Spellberg, B., Blaser, M. J., Guidos, R. J., et al. (2016). Combating antimicrobial resistance: policy recommendations to save lives. Clinical Infectious Diseases, 62(9), 1073-1078. [12] Gilbert, D. N., & Chambers, H. F. (2017). Emerging and re-emerging infectious diseases and antimicrobial resistance. JAMA, 317(19), 1965-1966. [13] U.S. Food & Drug Administration. (n.d.). Drug Development & FDA Approval Processes. [14] Morgan, D. J., et al. (2017). Antibiotic stewardship. Clinical Infectious Diseases, 65(suppl_1), S1-S8. [15] Mayo Clinic. (2022). Cefadroxil (Oral Route). [16] UpToDate. (n.d.). Cephalosporins: Overview of absorption, distribution, metabolism, and excretion. [17] British National Formulary. (2023). Cefadroxil. [18] Centers for Disease Control and Prevention. (2021). Methicillin-Resistant Staphylococcus aureus (MRSA).

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