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Last Updated: March 19, 2026

cefixime - Profile


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

Cefixime is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Lupin Ltd, Ajenat Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Lederle, Lupin Pharms, and Fdc Ltd, and is included in fifteen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cefixime has two patent family members in two countries.

Summary for cefixime
International Patents:2
US Patents:1
Tradenames:2
Applicants:8
NDAs:15
Paragraph IV (Patent) Challenges for CEFIXIME
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SUPRAX for Oral Suspension cefixime 500 mg/5 mL 202091 1 2016-07-22

US Patents and Regulatory Information for cefixime

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkem Labs Ltd CEFIXIME cefixime CAPSULE;ORAL 210574-001 Oct 9, 2018 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Lupin Ltd SUPRAX cefixime CAPSULE;ORAL 203195-001 Jun 1, 2012 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ajenat Pharms CEFIXIME cefixime FOR SUSPENSION;ORAL 206938-001 Feb 6, 2017 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ajenat Pharms CEFIXIME cefixime FOR SUSPENSION;ORAL 206938-002 Feb 6, 2017 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ajenat Pharms CEFIXIME cefixime FOR SUSPENSION;ORAL 206939-001 Feb 6, 2017 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Alkem Labs Ltd CEFIXIME cefixime FOR SUSPENSION;ORAL 211775-001 Feb 19, 2021 AB RX 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

Cefixime Investment and Fundamentals Analysis

Last updated: February 22, 2026

What Is Cefixime?

Cefixime is an oral third-generation cephalosporin antibiotic. It is used to treat bacterial infections such as urinary tract infections, gonorrhea, bronchitis, and pharyngitis. It functions by inhibiting bacterial cell wall synthesis, leading to bacterial death.

Market Overview

  • Global Market Size: Estimated at USD 1.2 billion in 2022.
  • Growth Rate: Compound annual growth rate (CAGR) of approximately 3-4% over the next five years (2023-2028).
  • Key Regions: North America, Europe, Asia-Pacific.
  • Major Players: GlaxoSmithKline, Teva Pharmaceuticals, Lupin Pharmaceuticals, and Hikma Pharmaceuticals.

Patent and Regulatory Status

  • Patent Expiry: Most patents for cefixime formulations expired between 2015 and 2018, leading to increased generic competition.
  • Regulatory Approvals: Widely approved in the U.S. (FDA), Europe (EMA), and other markets.
  • Generic Market Entry: Dominates the market since patent expiration, pressing down prices.

Investment Fundamentals

Revenue and Market Share Trends

Year Estimated Global Sales (USD billions) Key Drivers
2022 1.2 Increased generic penetration
2023 1.3 Growing demand in Asia
2024+ 1.4+ Stabilization of market share
  • The market's growth is driven by rising antibiotic use for community-acquired infections, especially in emerging markets where antibiotic access expands.
  • Price erosion continues due to increased generic competition, resulting in lower profit margins for large producers.

Competitive Landscape

  • The market features several generic manufacturers that compete primarily on price.
  • Few branded formulations remain in markets like the U.S. due to patent expiry.
  • Established players benefit from manufacturing scale and distribution networks.

R&D Investment and Product Pipeline

  • R&D focus has shifted from cefixime to broader-spectrum antibiotics and combination therapies.
  • Limited pipeline development specific to cefixime indicates declining innovation interest, pressuring potential for lifecycle extensions or reformulations.

Cost Structure and Pricing

  • Pricing: Average retail price of cefixime in the U.S. approximately USD 20-30 per 30-tablet pack for generics.
  • Manufacturing Costs: Low, benefiting from established synthesis pathways and high competition.
  • Margins: Margins have compressed, with some generic manufacturers operating at 10-15% gross margins.

Regulatory Risks and Market Dynamics

  • Stricter antibiotic stewardship policies impact prescription volumes.
  • Regulatory authorities emphasize restricting overuse to combat resistance, potentially reducing market size.

Investment Risks and Opportunities

Risks

  • Resistance Development: Bacterial resistance reduces cefixime's effectiveness, shrinking the market size over time.
  • Pricing Pressure: Continued generic competition compresses margins.
  • Regulatory Changes: Restrictions on antibiotic prescriptions could limit sales.

Opportunities

  • Emerging Markets: Population growth and increased healthcare access support demand.
  • New Formulations: Reformulations to combat resistance or improve compliance could extend product lifecycle.
  • Partnerships: Collaborations with regional generic producers may strengthen market position.

Financial Outlook

  • Revenue Prospects: Stabilize around USD 1.2-1.4 billion annually; growth driven by volume, not price.
  • Profitability: Margins under pressure; profitability hinges on operational efficiencies and market share management.
  • Investment Horizon: Medium to long-term, with growth potential primarily in emerging markets and lifecycle management.

Key Takeaways

  • Cefixime's market is mature with declining innovation and intense generic competition.
  • Revenue is expected to remain stable or marginally grow due to regional demand, especially in Asia-Pacific.
  • Profit margins face continued compression from pricing pressures.
  • Strategic opportunities revolve around emerging markets and potential new formulations.
  • Regulatory trends toward antimicrobial stewardship could impact future sales volume.

FAQs

Q1: What is the primary driver of cefixime sales?
Regional demand for affordable bacterial infection treatments and increased access in emerging markets.

Q2: How does patent expiry affect the cefixime market?
Generic entry post-patent expiry leads to price declines and increased competition.

Q3: Are there any promising innovations in cefixime formulations?
Limited. Most innovation focuses on broad-spectrum antibiotics or combination therapies.

Q4: Which regions hold the most growth potential?
Asia-Pacific and Latin America, driven by rising healthcare infrastructure and infection rates.

Q5: What are the main regulatory challenges facing cefixime?
Antimicrobial resistance policies and prescription restrictions could limit market growth.


References

  1. MarketWatch. (2022). "Cephalosporin antibiotics market size."
  2. IQVIA. (2022). "Global antibiotic market analysis."
  3. FDA. (2020). "G Respiratory and Antibiotic Drug Approvals."
  4. European Medicines Agency. (2022). "Antimicrobial resistance policies."
  5. GlobalData. (2023). "Pharmaceutical pipeline and market dynamics."

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