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Last Updated: March 19, 2026

cefadroxil/cefadroxil hemihydrate - Profile


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What are the generic sources for cefadroxil/cefadroxil hemihydrate and what is the scope of freedom to operate?

Cefadroxil/cefadroxil hemihydrate is the generic ingredient in three branded drugs marketed by Aurobindo Pharma, Chartwell Rx, Cspc Ouyi, Hikma, Ivax Sub Teva Pharms, Lupin, Purepac Pharm, Ranbaxy Labs Ltd, Sandoz, Teva, Teva Pharms, Warner Chilcott, Bristol, Ani Pharms, Apothecon, Aurobindo, Hikma Pharms, Sun Pharm Inds Ltd, and Ranbaxy, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.

Summary for cefadroxil/cefadroxil hemihydrate
US Patents:0
Tradenames:3
Applicants:19
NDAs:30

US Patents and Regulatory Information for cefadroxil/cefadroxil hemihydrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma CEFADROXIL cefadroxil/cefadroxil hemihydrate CAPSULE;ORAL 065352-001 Jan 25, 2007 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Chartwell Rx CEFADROXIL cefadroxil/cefadroxil hemihydrate CAPSULE;ORAL 065309-001 Sep 18, 2006 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Cspc Ouyi CEFADROXIL cefadroxil/cefadroxil hemihydrate CAPSULE;ORAL 205072-001 Jul 28, 2017 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hikma CEFADROXIL cefadroxil/cefadroxil hemihydrate CAPSULE;ORAL 065311-001 Feb 7, 2006 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ivax Sub Teva Pharms CEFADROXIL cefadroxil/cefadroxil hemihydrate CAPSULE;ORAL 062766-001 Mar 3, 1987 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Lupin CEFADROXIL cefadroxil/cefadroxil hemihydrate CAPSULE;ORAL 065392-001 May 29, 2007 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Purepac Pharm CEFADROXIL cefadroxil/cefadroxil hemihydrate CAPSULE;ORAL 063017-001 Jan 5, 1989 DISCN No 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

Cefadroxil/cefadroxil hemihydrate Market Analysis and Financial Projection

Last updated: February 4, 2026

What Is the Market and Investment Outlook for Cefadroxil?

Cefadroxil, a cephalosporin antibiotic, has been used for bacterial infections including skin, urinary tract, and respiratory infections. Cefadroxil hemihydrate, the salt form, enhances solubility and stability. Its mature patent status, generic competition, and off-patent status influence investment viability. The drug’s patent expiration occurred over a decade ago, leading to widespread generic availability. This status results in low pricing pressure but limits high-margin opportunities.

The global antibiotic market valuation stood at approximately $50 billion in 2022. Cefadroxil accounts for a small segment within this market, with sales predominantly in Europe, Asia, and Latin America. Growth vectors include rising bacterial resistance, increasing infection rates, and expanding healthcare access in emerging markets.

How Do the Drug’s Fundamentals Affect Investment Potential?

Patent and Regulatory Status

Cefadroxil has been off patent since the early 2010s. Regulatory filings are well-established, with approvals in multiple jurisdictions. Generic manufacturers dominate distribution; no recent major regulatory hurdles impede market access.

Market Size and Competition

Despite a mature market, cefadroxil faces stiff competition from other antibiotics such as cephalexin, cefadroxil’s close analogue, and newer broad-spectrum agents. The drug generates modest revenue—estimated at around $200–300 million annually globally for generic manufacturers.

Pricing and Margins

Pricing in the generic segment averages between $0.10 and $0.50 per pill, depending on geographic region. Gross margins are limited, with price pressure due to competition. Investment payback relies on high-volume sales, cost-effective manufacturing, and market expansion.

Manufacturing and Supply Chain

The drug's manufacturing process relies on established synthesis routes, with key raw materials readily available. Supply chain stability for cefadroxil is high, reducing procurement risk. Manufacturing costs are low relative to revenue potential, providing some buffer for margins.

Emerging Market Dynamics

Growth is driven by rising infection incidences and limited antibiotic options in emerging economies. Local manufacturers frequently produce cefadroxil generics, further increasing competition but also expanding potential volume markets.

Regulatory Risks and Opportunities

While regulatory pathways are clear, antimicrobial stewardship policies in developed markets could reduce prescription volumes over time. Conversely, new diagnostic tools and rising resistant strains could sustain demand.

Investment Risks and Opportunities

Risks

  • Market saturation due to generic competition.
  • Price erosion driven by high-volume, low-margin dynamics.
  • Regulatory policies promoting antibiotic stewardship.
  • Potential development of resistance reducing efficacy.

Opportunities

  • Growth in emerging markets due to expanding healthcare infrastructure.
  • Potential partnerships or licensing for formulation enhancements.
  • Product line expansion incorporating cefadroxil in combination therapies.

Financial and Strategic Considerations

Investors should evaluate companies with established manufacturing capacity and distribution channels for cephalosporins. M&A activity may target mid-sized generic firms with high-volume sales in emerging markets.

Key Takeaways

  • Cefadroxil has a mature, highly competitive global market with limited near-term revenue growth.
  • Its patent expiry leads to widespread generic availability, reducing pricing power.
  • Investment should prioritize manufacturers with low-cost production, broad distribution, and exposure to emerging markets.
  • Growth prospects hinge on market expansion rather than pharmaceutical innovation.
  • Risks include regulatory changes and antimicrobial stewardship policies that could constrain volume.

Frequently Asked Questions

  1. What is the current patent status of cefadroxil?
    It expired in most regions over a decade ago, leading to multiple generic manufacturers.

  2. What markets show the highest demand for cefadroxil?
    Emerging markets in Asia, Latin America, and parts of Africa have higher demand due to limited alternative antibiotics.

  3. Are there any new formulations or combination therapies involving cefadroxil?
    No significant recent innovation; most use remains with traditional formulations.

  4. What are key regulatory considerations for investing in cefadroxil?
    Regulatory approvals are well-established; however, local antimicrobial policies vary and influence sales.

  5. How does antibiotic resistance affect cefadroxil’s future?
    Rising resistance could limit efficacy; stewardship policies may curtail sales, especially in developed markets.


References

[1] MarketWatch, "Global Antibiotic Market Size, Share & Trends," 2022.
[2] EvaluatePharma, "Top Line Data," 2022.
[3] FDA, "Approved Drugs Database," 2023.
[4] World Health Organization, "Antimicrobial Resistance," 2021.

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