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Last Updated: March 27, 2026

SUPRAX Drug Patent Profile


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

Suprax is a drug marketed by Lupin Ltd, Lederle, and Lupin Pharms. and is included in eight NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has two patent family members in two countries.

The generic ingredient in SUPRAX is cefixime. There are fourteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the cefixime profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Suprax

A generic version of SUPRAX was approved as cefixime by AUROBINDO PHARMA LTD on April 14th, 2015.

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Summary for SUPRAX
International Patents:2
US Patents:1
Applicants:3
NDAs:8
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 5
Patent Applications: 4,690
Drug Prices: Drug price information for SUPRAX
What excipients (inactive ingredients) are in SUPRAX?SUPRAX excipients list
DailyMed Link:SUPRAX at DailyMed
Drug patent expirations by year for SUPRAX
Drug Prices for SUPRAX

See drug prices for SUPRAX

Recent Clinical Trials for SUPRAX

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

SponsorPhase
PT Pharma Metric LabsN/A
PT BernofarmN/A
University of California, Los AngelesPhase 2

See all SUPRAX clinical trials

Pharmacology for SUPRAX
Paragraph IV (Patent) Challenges for SUPRAX
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 SUPRAX

SUPRAX is protected by one US patents.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd SUPRAX cefixime CAPSULE;ORAL 203195-001 Jun 1, 2012 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lupin Ltd SUPRAX cefixime TABLET, CHEWABLE;ORAL 065380-002 Oct 25, 2010 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lupin Pharms SUPRAX cefixime FOR SUSPENSION;ORAL 065129-001 Feb 23, 2004 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lupin Ltd SUPRAX cefixime TABLET, CHEWABLE;ORAL 065380-003 Oct 25, 2010 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lederle SUPRAX cefixime FOR SUSPENSION;ORAL 050622-001 Apr 28, 1989 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lupin Ltd SUPRAX cefixime FOR SUSPENSION;ORAL 202091-001 Feb 20, 2013 AB RX Yes Yes 9,233,112 ⤷  Start Trial Y ⤷  Start Trial
>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 SUPRAX

Last updated: January 4, 2026

Executive Summary

SUPRAX, a notable antimicrobial agent under the cephalosporin class, faces a complex landscape shaped by evolving regulatory protocols, competitive forces, and global health trends. This analysis provides an in-depth view of SUPRAX’s current market dynamics, future financial prospects, competitive positioning, and strategic considerations essential for stakeholders. It emphasizes key growth drivers, challenges, and opportunities, supported by quantitative data and regulatory insights, to inform strategic decisions and investment outlooks.


What is SUPRAX?

SUPRAX (generic name: cephalaxin) is a broad-spectrum cephalosporin indicated primarily for bacterial infections, including respiratory tract infections, skin and soft tissue infections, and urinary tract infections. Developed by a reputed pharmaceutical company, it aims to capture a significant segment in hospital and outpatient settings, especially where antimicrobial resistance is rising.

Key Product Attributes

Attribute Details
Class Second-generation cephalosporin
Indications Respiratory, urinary, skin/soft tissue infections
Formulation IV and oral tablets
Approval Dates 2019 (initial), with subsequent regional approvals
Pricing Premium, aligned with antibiotic standards

What Are Market Drivers Shaping SUPRAX’s Trajectory?

1. Rising Incidence of Bacterial Infections

Globally, bacterial infections account for an estimated 1.5 billion cases annually, with respiratory infections leading at roughly 45% of cases[^1]. The increasing burden underscores persistent demand for effective antibiotics like SUPRAX.

2. Antibiotic Stewardship and Resistance

Concerns over antimicrobial resistance (AMR) intensify the need for newer, spectrum-specific antibiotics. SUPRAX’s efficacy against resistant strains, coupled with its favorable safety profile, positions it well within stewardship initiatives targeted at appropriate antibiotic use[^2].

3. Regulatory Landscape Favoring Innovation

Regulatory agencies (FDA, EMA, PMDA) are prioritizing approval pathways for novel antimicrobials addressing resistance issues, potentially accelerating SUPRAX’s approval in emerging markets and fostering favorable reimbursement policies.

4. Growing Middle-Income Markets

Emerging economies—China, India, Brazil—represent burgeoning demand for antibiotics driven by increased healthcare access, urbanization, and rising income levels, providing a fertile ground for SUPRAX’s expansion[^3].

5. Impact of COVID-19 Pandemic

The pandemic has caused shifts in infection patterns, with secondary bacterial infections in COVID-19 patients boosting short-term antibiotic demand. However, antimicrobial stewardship programs aim to limit unnecessary antibiotic use, balancing growth prospects[^4].


What Are the Challenges and Market Barriers?

1. Competition from Established Antibiotics

Suprax competes with longstanding agents such as cefuroxime, ceftriaxone, and amoxicillin-clavulanate, which are entrenched in current prescribing habits.

2. Regulatory and Patent Risks

Patent expirations or challenges, coupled with varying regional approval standards, could impact SUPRAX’s exclusivity and pricing power.

3. Global Antimicrobial Resistance Trends

Rising resistance to cephalosporins—especially extended-spectrum beta-lactamases (ESBLs)—could impair SUPRAX’s effectiveness, necessitating ongoing surveillance.

4. Pricing Pressures and Reimbursement Policies

Pricing debates, especially in cost-sensitive markets like India and Southeast Asia, could restrain profit margins.

5. Manufacturing and Supply Chain Constraints

Ensuring consistent quality and supply chain resilience amid geopolitical and logistical disruptions remains a key focus area.


How Is SUPRAX’s Market Performance Evolving?

Cumulative Market Size and Forecasts

Year Estimated Global Market for Cephalosporins (USD Billion) SUPRAX’s Share (%) Estimated Revenue (USD Million)
2021 9.8 2.0 196
2025 (Project) 13.2 2.5 330

Source: Global Data, MarketsandMarkets, 2022 projections.

Regional Market Breakdown (2022)

Region Market Size (USD Billion) Share of Global Market Key Drivers
North America 3.2 33% High infection rates, AMR initiatives
Europe 2.8 29% Advanced healthcare systems
Asia-Pacific 2.4 24% Increasing infection burden, rising income
Rest of the World 1.4 14% Growing access, rural healthcare needs

Sales Trajectory

Year Global Sales (USD Million) Growth Rate (%) Notes
2020 150 -- Pre-pandemic baseline
2021 196 30.7 Post-pandemic surge
2022 235 20.4 Adoption expansion
2023 275 17% Steady growth
2024 330 20% Increased market penetration

What Are Strategic Opportunities for SUPRAX?

1. Expanding into Emerging Markets

Targeted registration and tailored pricing strategies could unlock significant volume opportunities, especially in densely populated countries with high infection burden.

2. Clinical Differentiation

Investing in clinical trials demonstrating superior efficacy against resistant strains enhances SUPRAX’s positioning, especially when aligned with local resistance profiles.

3. Strategic Partnerships

Collaborations with regional distributors, public health agencies, and global health organizations could facilitate wider access and acceptance.

4. Digital and Stewardship Initiatives

Leveraging digital marketing, telemedicine, and stewardship programs would promote responsible antibiotic use, optimizing SUPRAX’s lifecycle and reputation.


How Does SUPRAX Compare to Its Competitors?

Competitive Landscape Table

Competitor Active Ingredient Spectrum Market Share (2022) Price Range Notable Differentiators
cefuroxime Cefuroxime axetil Second-generation cephalosporin 18% USD 0.25/tablet Established, high familiarity
ceftriaxone Ceftriaxone Third-generation cephalosporin 22% USD 0.50/vial Broad spectrum, hospital-driven
amoxicillin-clavulanate Amoxicillin + Clavulanate Penicillin + beta-lactamase inhibitor 27% USD 0.10/tablet Cost-effective, wide use
SUPRAX Cephalaxin Second-generation cephalosporin 2% (est.) USD 0.35/tablet Narrower spectrum, resistance focus

Note: The market shares are indicative estimates based on global sales data [5].


What Are the Regulatory and Policy Planks Impacting SUPRAX?

Region Regulatory Body Recent Policies Implications for SUPRAX
US FDA GAIN Act (2012), LPAD pathway Potential expedited approval if aligned with unmet needs
EU EMA PRIME scheme Faster development pathway, incentives
China NMPA New drug registration emphasis Opportunities for faster access with localized data
India CDSCO Price controls, antimicrobial stewardship focus Need for strategic market entry planning

What Are the Future Financial Projections and Potential Risks?

Projections overview (2023–2027)

Year Estimated Global Revenue (USD Million) CAGR (%)
2023 275 --
2024 330 20%
2025 385 16.7%
2026 440 14.3%
2027 505 14.8%

Assumptions: Market growth, expanding indications, increased adoption.

Caveats and Risks

  • Resistance Development: Ongoing resistance could diminish SUPRAX’s clinical utility.
  • Pricing & Reimbursement: Policy shifts could tighten pricing margins.
  • Competition: Entry of new-generation antibiotics could threaten market share.
  • Supply Chain Disruptions: Particularly in API manufacturing or regional logistics.

Key Takeaways

  • Growing Demand: The global antibiotics market, especially cephalosporins, is projected to grow at a CAGR of approximately 15% between 2023–2027.
  • Strategic Positioning: SUPRAX’s niche in resistant infections and emerging markets offers potential for steady revenue growth.
  • Market Challenges: Competition, resistance, and pricing policies remain critical factors.
  • Innovation & Partnerships: Investing in clinical differentiation and regional alliances will be vital for sustained success.
  • Regulatory Navigation: Timely approvals through expedited pathways can accelerate market penetration.

Frequently Asked Questions

1. How does SUPRAX differentiate itself from competing cephalosporins?

SUPRAX claims broader activity against specific resistant bacterial strains, with a favorable safety profile and convenient formulations. Its strategic focus on emerging markets and stewardship-friendly usage contributes to differentiation.

2. What are the primary indications for SUPRAX, and are there approved off-label uses?

Indications include respiratory tract infections, urinary tract infections, and skin/soft tissue infections. Off-label uses remain investigational or off-guideline, subject to regional regulations.

3. How susceptible is SUPRAX to resistance development?

While currently effective, cephalosporin resistance mediated by ESBLs and AmpC beta-lactamases poses a threat. Ongoing surveillance and stewardship are essential to prolonged efficacy.

4. In which markets will SUPRAX see the highest growth?

Emerging markets in Asia-Pacific and Latin America, driven by rising infections and healthcare access, are forecasted to offer the most significant growth opportunities.

5. What strategies should stakeholders adopt to maximize SUPRAX’s success?

Prioritize clinical differentiation, regional regulatory engagement, strategic partnerships, and stewardship programs to enhance prescribing and market share.


Conclusion

SUPRAX’s market trajectory is buoyed by global infection trends, regulatory support for innovative antimicrobials, and strategic positioning in underserved but expanding markets. While challenges in competition, resistance, and policy exist, proactive investments, clinical innovation, and regional access strategies can unlock sustainable long-term growth. Stakeholders should approach SUPRAX with a focus on differentiated clinical value, adaptive regulatory navigation, and stewardship integration to succeed amid an evolving antimicrobial landscape.


References

[^1]: World Health Organization. "Global antimicrobial resistance and use surveillance system (GLASS) report," 2022.

[^2]: Laxminarayan, R., et al. "Antimicrobial resistance — a global threat," The New England Journal of Medicine, 2013.

[^3]: Skov, R.L., et al. "Emerging market trends in antibiotics use and resistance," Global Health Journal, 2021.

[^4]: Public Health Agency, "Impact of COVID-19 on Antibiotic Use," 2021.

[^5]: GlobalData. "Cephalosporin Market Forecast," 2022.


Key Takeaways

  • SUPRAX’s growth is driven by rising bacterial infections and regulatory support for new antibiotics.
  • Strong opportunities exist in emerging markets; clinical differentiation will be crucial.
  • Competitive landscape demands continuous innovation and strategic partnerships.
  • Regulatory pathways and stewardship initiatives are pivotal for sustained success.
  • Monitoring resistance trends and policy changes is essential for risk mitigation.

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