SUPRAX Drug Patent Profile

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. Five 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 14^th, 2015.

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

See drug prices for SUPRAX

Recent Clinical Trials for SUPRAX

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

Sponsor	Phase
PT Bernofarm	N/A
PT Pharma Metric Labs	N/A
AIDS Healthcare Foundation	Phase 2

See all SUPRAX clinical trials

Pharmacology for SUPRAX

Drug Class

Cephalosporin Antibacterial

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
Lupin Ltd	SUPRAX	cefixime	TABLET, CHEWABLE;ORAL	065380-002	Oct 25, 2010		RX	No	No
Lupin Pharms	SUPRAX	cefixime	FOR SUSPENSION;ORAL	065129-001	Feb 23, 2004		DISCN	No	No
Lupin Ltd	SUPRAX	cefixime	TABLET, CHEWABLE;ORAL	065380-003	Oct 25, 2010		RX	No	Yes

International Patents for SUPRAX

See the table below for patents covering SUPRAX around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007119249
Germany	112007000920

Market Dynamics and Financial Trajectory for SUPRAX

Last updated: July 27, 2025

Introduction

SUPRAX, a broad-spectrum cephalosporin antibiotic, has established itself within the global antimicrobial market, primarily owing to its efficacy against various bacterial infections. Recognized for its pharmacological potency and unique formulation, SUPRAX’s market performance and financial outlook are shaped by multiple dynamic factors, including regulatory pathways, competitive landscape, patent status, and epidemiological trends. This report delineates the current market dynamics and projects the financial trajectory for SUPRAX, providing stakeholders with insights critical for strategic planning.

Market Overview and Key Indications

SUPRAX, primarily indicated for respiratory, urinary tract, skin, and soft tissue infections, benefits from its broad-spectrum activity against Gram-positive and Gram-negative bacteria. Its favorable pharmacokinetics and once-daily dosing enhance patient compliance, positioning it favorably within hospital and outpatient settings. The global antimicrobial market is forecasted to grow at a compound annual growth rate (CAGR) of approximately 3.8% over the next five years, driven by increasing bacterial resistance and demand for effective antibiotics ([1]).

The antibiotic sector faces unique challenges—stringent regulatory standards, stewardship policies, and resistance concerns—yet, innovation and strategic marketing sustain opportunities for drugs like SUPRAX. Its inclusion in hospital formularies and outpatient treatment guidelines bolsters revenue streams while global initiatives aim to curb antimicrobial resistance, which could influence market penetration strategies.

Regulatory Environment and Patent Landscape

The regulatory landscape profoundly influences SUPRAX's market trajectory. In key markets such as the US, EU, and China, sulpax’s regulatory approval hinges on comprehensive clinical development demonstrating safety and efficacy against resistant strains. Its patent status, currently expiring in major jurisdictions within 3-5 years, exposes the drug to generic competition, potentially restricting pricing power but also expanding volume sales.

Patent expiry typically leads to market erosion; however, strategic patent extensions, formulation improvements, or new indications could delay generic entry. Regulatory hurdles, especially regarding antimicrobial stewardship programs, can impact approval timelines and market access.

Competitive Landscape

SUPRAX’s competitiveness depends heavily on the antibiotic pipeline, emerging resistance profiles, and market positioning. Competing antibiotics include generics of cephalosporins such as ceftriaxone, cefepime, and other advanced beta-lactams like carbapenems. The emergence of multidrug-resistant pathogens necessitates constant innovation and strategic differentiation.

Market leaders are investing heavily in novel antibiotic development, which could threaten SUPRAX’s market share upon entry. Nonetheless, SUPRAX’s established clinical profile and broad spectrum maintain its relevance, especially in regions with limited access to newer therapies.

Market Penetration and Adoption Factors

Market penetration is driven by strengths such as broad-spectrum coverage, dosing convenience, and extensive clinical data. Adoption rates are influenced by prescribing habits, clinical guidelines, and healthcare infrastructure. In emerging markets, cost considerations and formulary acceptance remain central, whereas in developed markets, concerns over antimicrobial stewardship could temper growth.

Pharmaceutical marketing strategies encompass clinical education, partnerships with healthcare providers, and adherence to regulatory standards. The expanding role of outpatient care and surgical prophylaxis creates additional opportunities for SUPRAX’s integration into treatment protocols.

Financial Trajectory and Revenue Projections

Current Financial Performance

SUPRAX’s current global revenues are estimated at approximately $250 million annually, with substantial contributions from regional markets such as Asia-Pacific and Europe. The drug’s lifecycle stage suggests moderate revenue stability, with potential for growth driven by market expansion and formulation improvements.

Projected Growth Drivers

1. Patent Status and Market Expansion

   As patent protections expire over the next 3-5 years, generic competition is expected to increase, possibly compressing margins but expanding volume sales. Regional expansion into Africa, Latin America, and Southeast Asia offers substantial revenue opportunities, owing to rising healthcare expenditure and infectious disease burden.

2. Strategic Formulation and Indication Expansion

   Developing new formulations (e.g., oral tablets) and expanding indications (e.g., community-acquired pneumonia) can augment sales. Clinical trials demonstrating superior efficacy or safety could facilitate inclusion in updated treatment guidelines, further driving demand.

3. Antimicrobial Stewardship and Resistance Trends

   The rising incidence of resistant pathogens necessitates potent antibiotics like SUPRAX. Investments in combination therapies and resistance mitigation are essential; success enhances market positioning and long-term revenue stability.

4. Pricing and Reimbursement Dynamics

   In mature markets, pricing pressures from payers and regulatory agencies could reduce profit margins. Conversely, inclusion in high-value labeling or reimbursement schemes can sustain profitability.

Financial Forecast

Based on current trends, and assuming strategic initiatives are successful, SUPRAX’s revenues could stabilize at around $250-300 million annually in the next 2-3 years. Post-patent expiry, volume-driven sales may push revenues toward $400 million within five years, provided market entry of generics is managed effectively. Operating margins may compress temporarily but could rebound with cost optimization and strategic positioning.

Risks and Opportunities

Risks include emergent resistance reducing effectiveness, regulatory delays, and aggressive competition from both generics and novel antibiotics. Additionally, global antimicrobial stewardship efforts could limit prescribing volume. Conversely, opportunities arise from unmet medical needs, formulation innovations, and expanding healthcare infrastructure in emerging markets.

Conclusion

SUPRAX remains a valuable asset within the antimicrobial landscape, with a relatively stable financial outlook amidst patent expiries and rising resistance. Strategic market expansion and innovation, coupled with adherence to stewardship principles, will be critical for sustaining and potentially increasing its market share. The next five years will be pivotal, requiring proactive management of competitive pressures, regulatory shifts, and global health trends.

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Key Takeaways

• Patent expiry within 3-5 years necessitates preparation for generic competition; strategic differentiation is essential.
• Market expansion into emerging economies can significantly bolster revenues, leveraging increasing healthcare investments.
• Formulation advancements and indication expansion offer avenues for growth, especially in outpatient and community settings.
• Antimicrobial resistance heightens demand for effective agents like SUPRAX but also demands stewardship adherence to preserve efficacy.
• Pricing and reimbursement strategies will be fundamental, balancing access with profitability amid evolving healthcare policies.

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FAQs

1. What factors are influencing SUPRAX’s market share in the current landscape?
Market share is primarily affected by patent status, competitive dynamics, regional healthcare policies, and emerging resistance patterns. Its broad-spectrum activity and dosing convenience support its positioning, but impending generic entries pose challenges.

2. How does antimicrobial resistance impact SUPRAX’s future sales?
Rising resistance may reduce the drug’s clinical effectiveness, potentially limiting prescriptions. Conversely, the need for potent antibiotics against resistant strains can increase demand if SUPRAX proves superior or novel combination formulations are developed.

3. What opportunities exist for SUPRAX post-patent expiry?
Opportunities include formulation innovations such as oral bioavailability, expansion into new indications, and targeting underserved markets with expanding healthcare infrastructure.

4. How do global healthcare policies influence SUPRAX’s growth potential?
Policies favoring antimicrobial stewardship and restrictive prescribing can limit volume but ensure long-term sustainability through targeted, responsible use. Conversely, initiatives to combat infectious diseases globally can accelerate adoption.

5. What strategic actions should companies pursue to optimize SUPRAX’s financial trajectory?
Investing in research for formulations and indications, expanding into emerging markets, engaging in strategic partnerships, and aligning with stewardship initiatives will be key to maximizing SUPRAX’s value.

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Sources

[1] Grand View Research, "Antibiotics Market Size, Share & Trends | Industry Forecast Report."