Last Updated: June 17, 2026

CEFTIN Drug Patent Profile


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

Ceftin is a drug marketed by Glaxosmithkline and is included in two NDAs.

The generic ingredient in CEFTIN is cefuroxime axetil. There are sixty-two drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ceftin

A generic version of CEFTIN was approved as cefuroxime axetil by CHARTWELL RX on July 29th, 2005.

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Summary for CEFTIN
US Patents:0
Applicants:1
NDAs:2

US Patents and Regulatory Information for CEFTIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline CEFTIN cefuroxime axetil FOR SUSPENSION;ORAL 050672-001 Jun 30, 1994 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline CEFTIN cefuroxime axetil TABLET;ORAL 050605-002 Dec 28, 1987 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline CEFTIN cefuroxime axetil FOR SUSPENSION;ORAL 050672-002 Apr 29, 1997 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline CEFTIN cefuroxime axetil TABLET;ORAL 050605-001 Dec 28, 1987 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline CEFTIN cefuroxime axetil TABLET;ORAL 050605-003 Dec 28, 1987 DISCN Yes 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

Investment Scenario and Fundamentals Analysis for CEFTIN (Cefuroxime Axetil)

Last updated: February 9, 2026

What Is the Market Position of CEFTIN?

CEFTIN is a branded antibiotic primarily used for bacterial infections such as respiratory tract infections, otitis media, and urinary tract infections. It is a second-generation cephalosporin with a broad-spectrum activity. The drug is marketed globally with varying degrees of market penetration, facing competition from both generic formulations and other antibiotics.

How Does the Pharmacological Profile Influence Its Market Viability?

The drug's efficacy against common bacterial pathogens, favorable safety profile, and oral dosing form underpin its sustained demand. Its spectrum covers pathogens like Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, making it a go-to oral antibiotic for community-acquired infections.

What Are the Market Dynamics and Regulatory Context?

The global antibiotic market is driven by rising infection rates, growing awareness, and expanding outpatient use. CEFTIN benefits from a well-established regulatory approval in mature markets like the US, Europe, and Japan. Yet, it faces pressure from generic competition, especially once patents expire.

In the US, the drug’s patent expiration occurred around 2015 for some formulations, leading to increased generic competition. Its market share has declined accordingly, but brand loyalty and physician prescribing habits continue to support some level of branded sales.

Regulatory risks include evolving antimicrobial stewardship policies, which could constrain prescribing or accelerate shifts toward narrow-spectrum or alternative antibiotics.

How Profitable Is CEFTIN’s Market Position?

The revenue generated by CEFTIN in major markets has stabilized following patent expiry, with total sales estimated at approximately $150 million annually pre-generic influx. Post-expiry, sales waned but remained viable through brand loyalty, established distribution channels, and new formulations or combinations.

Cost structures for manufacturing generic cefuroxime components are low, boosting margins for generic producers. The patent landscape remains key; newer formulations or fixed-dose combinations may extend exclusivity, maintaining profitability for patent holders.

What Are the Investment Risks?

  • Patent Expiry and Generic Competition: Loss of exclusivity diminishes revenues, increases price competition, and erodes market share.
  • Regulatory Changes: Stricter antimicrobial stewardship policies may reduce prescribing.
  • Resistance Development: Bacterial resistance to cephalosporins could reduce clinical utility.
  • Market Saturation: Established antibiotics like CEFTIN face limited growth prospects given the mature, saturated nature of the segment.

What Growth Opportunities Exist?

  • New Formulations: Developing sustained-release or combination formulations to extend patent life.
  • Global Expansion: Penetration into emerging markets where antibiotics are under prescribing regulation but demand growth exists.
  • Diagnostics & Stewardship: Partnering with diagnostic companies to promote targeted therapy, which can support niche growth.
  • Biosimilars & Generics: Entry into markets with lower-cost generic cefuroxime options.

How Do Competition and Innovation Impact the Future?

Generic cefuroxime formulations challenge CEFTIN’s pricing and market share. Biomarker-guided therapy and alternative antibiotic classes, such as macrolides or fluoroquinolones, further fragment the market. Proprietary formulations or delivery methods could offer differentiation but require significant R&D investments.

Financial Outlook Summary

  • Revenue Trends: Declined post-patent expiry but stabilization with potential niche markets.
  • Margins: High for patent-holder pre-expiry, eroding with generics.
  • R&D Investment: Necessary for extending lifecycle through new formulations or indications.

Key Takeaways

  • CEFTIN is a broad-spectrum, well-established antibiotic with stable but declining branded revenues post-patent expiry.
  • Growing generic competition and antimicrobial resistance present challenges.
  • Investment prospects depend on innovation, geographic expansion, and the ability to extend patent protections or create niche markets.
  • Shift toward stewardship and personalized medicine pose regulatory and clinical adoption risks.
  • Opportunities exist in formulation innovation and global market growth, but progress requires significant investment.

FAQs

1. What is CEFTIN’s patent status?
CEFTIN’s primary patents expired around 2015, leading to increased generic competition in key markets.

2. Can CEFTIN be used for resistant infections?
Not typically. Resistance to cephalosporins like cefuroxime has increased, particularly in hospital settings, limiting its role in resistant infections.

3. What regions show the highest growth potential?
Emerging markets in Asia and Latin America see rising demand for antibiotics, subject to evolving regulations.

4. What are the main competitors?
Generic cefuroxime products and alternative broad-spectrum antibiotics such as amoxicillin-clavulanate and azithromycin.

5. How can developers extend CEFTIN’s lifecycle?
Through new formulations, combination products, or identifying new therapeutic indications.


Citations

[1] IMS Health (now IQVIA), Antibiotic Market Data, 2022.

[2] FDA, Patent and Exclusivity Information, 2022.

[3] MarketWatch, Antibiotics Market Analysis, 2022.

[4] GlobalData, Emerging Markets, Antibiotics Outlook, 2022.

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