SUPRAX Drug Patent Profile

Which patents cover Suprax, 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 14^th, 2015.

Summary for SUPRAX

International Patents:	2
US Patents:	1
Applicants:	3
NDAs:	8

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		DISCN	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		DISCN	No	No

International Patents for SUPRAX

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

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

Investment Scenario and Fundamentals Analysis for SUPRAX (Ceftriaxone)

Last updated: February 20, 2026

What is SUPRAX and How Does It Fit Into the Market?

SUPRAX is a trade name commonly associated with ceftriaxone, a third-generation cephalosporin antibiotic. It is administered via intramuscular or intravenous injection to treat a broad range of bacterial infections, including respiratory tract infections, urinary tract infections, and meningitis. Ceftriaxone's broad-spectrum activity and favorable pharmacokinetics make it a standard option in hospitals worldwide.

Market estimates project ceftriaxone's global sales to reach approximately $3.2 billion in 2023, driven by demand for broad-spectrum antibiotics and the ongoing prevalence of bacterial infections. Key markets include North America, Europe, and Asia, with emerging markets showing growth potential due to increasing healthcare access and antibiotic usage.

How Does SUPRAX Stand in the Competitive Landscape?

Ceftriaxone competes primarily with other third-generation cephalosporins such as cefotaxime, ceftazidime, and cefepime. Market share is dominated by established pharmaceutical companies with extensive distribution networks:

Company	Product Name	Market Share (2022)	Estimated Revenue (2022)	R&D Portfolio Focus
Pfizer	Rocephin	62%	$1.97 billion	Broad-spectrum antibiotics, vaccine development
Sandoz (Novartis)	Ceftriaxone	15%	Part of Novartis' $19B vaccines & antibiotics segment	Biosimilars, antibiotics, other injectables
Teva	Ceftriaxone	8%	$5.4 billion (overall Teva pharma)	Generic injectables, biosimilars
Others	Various	15%	N/A	Innovation in narrow-/broad-spectrum antibiotics, local generics

The competition emphasizes manufacturing capacity, price competitiveness, and patent expiration timelines. SUPRAX, mainly marketed by Indian and Chinese generic producers, benefits from lower manufacturing costs but faces patent challenges and regulatory hurdles in certain regions.

What Are the Key Patents and Regulatory Barriers?

Ceftriaxone's foundational patents expired in most markets by 2018, facilitating generic entry. However, combination formulations, delivery systems, and specific formulations may still be under patent protection or regulatory exclusivity, especially in developing markets.

Key regulatory factors include:

• FDA and EMA Approvals: Existing approvals cover safety and efficacy, with most generic SUPRAX formulations gaining rapid approval due to bioequivalence data.
• Market Approvals: Countries like India and China have streamlined regulatory pathways for generics, expediting market entry.

Regulatory delays or restrictions on antibiotic use can influence market penetration and profitability.

What Are the R&D and Innovation Trends?

Despite ceftriaxone being a mature molecule, innovation focuses on:

• New Formulations: Extended-release injectables designed for less frequent dosing.
• Combination Therapies: Pairing ceftriaxone with other antibiotics to broaden efficacy.
• Alternative Delivery: Liposomal or nanoparticle-based formulations to improve bioavailability and reduce dosing frequency.

Large pharma companies are less actively investing in ceftriaxone R&D due to patent expiration and high development costs. Smaller firms and generics manufacturers prioritize cost-effective manufacturing and expanding regional distribution.

What Are the Financial and Investment Considerations?

From an investment perspective:

• Market Maturity: Ceftriaxone is a mature product with limited growth potential in high-income markets; however, emerging markets offer rapid expansion.
• Pricing Dynamics: Strong competition and generic availability pressure prices downward in mature markets.
• Patents and Exclusivity: Patent expirations open avenues for generic competition, increasing market share but reducing product margins.
• Regulatory Risks: Changes in antibiotic stewardship policies could reduce demand; regulatory restrictions on antibiotic use may impact sales.

Forecasts suggest a compound annual growth rate (CAGR) of roughly 3% for ceftriaxone-based sales through 2027, driven primarily by emerging markets.

What Are the Strategic Opportunities and Risks?

Opportunities:

• Entering regional markets with limited generic penetration.
• Developing new formulations and combination therapies.
• Capitalizing on healthcare infrastructure expansion in Asia, Africa, and Latin America.

Risks:

• Stricter antibiotic use regulations.
• Potential emergence of resistance reducing efficacy.
• Increasing commoditization leading to margin erosion.

Investors should consider the product's lifecycle stage, regional regulatory environment, and company R&D pipeline when evaluating SUPRAX.

Key Takeaways

• SUPRAX (ceftriaxone) is a mature, widely used antibiotic with significant sales in hospitals worldwide.
• Market growth relies heavily on emerging markets, while developed markets face pricing pressures from generics.
• Patent expiry has facilitated generic competition; future profit margins depend on manufacturing efficiency and regional market share.
• Innovation in formulations and combinations represents a strategic opportunity but has limited scope given product maturity.
• Regulatory and antimicrobial resistance trends pose ongoing risks.

FAQs

1. What is the primary competitive advantage of SUPRAX?
It offers broad-spectrum activity with proven safety and efficacy, supported by extensive clinical use, especially in hospitals.

2. How does patent expiration impact SUPRAX's marketability?
It enables generic manufacturers to enter the market, decreasing prices and profit margins for brand owners.

3. Which regions present the most growth opportunities for SUPRAX?
Emerging markets in Asia, Africa, and Latin America, due to increasing healthcare access and growing antibiotic consumption.

4. Are there any ongoing R&D efforts to modify SUPRAX?
Yes, research focuses on new delivery systems, combination formulations, and extended-release versions, though these are primarily at early development stages.

5. What are the key regulatory considerations for SUPRAX?
Regulatory approval depends on regional agencies' bioequivalence and safety assessments; antibiotic stewardship policies could restrict use.

References

1. Market Research Future. (2023). Ceftriaxone Market Analysis. [Data report].
2. EvaluatePharma. (2022). 2022 Global Antibiotics Market Report.
3. IQVIA. (2022). The Global Use of Antibiotics and Market Trends.
4. U.S. Food and Drug Administration. (2022). Guidance on Generic Antibiotics Approval.
5. World Health Organization. (2021). Antimicrobial Resistance: Global Report on Surveillance.