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. Seven 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:	71
Clinical Trials:	5
Patent Applications:	7,475
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 Pharma Metric Labs	N/A
PT Bernofarm	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
Lederle	SUPRAX	cefixime	FOR SUSPENSION;ORAL	050622-001	Apr 28, 1989		DISCN	Yes	No
Lupin Ltd	SUPRAX	cefixime	FOR SUSPENSION;ORAL	202091-001	Feb 20, 2013	AB	RX	Yes	Yes			Y

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 (Cefixime)

Introduction to Suprax

Suprax, also known as cefixime, is a broad-spectrum cephalosporin antibiotic widely used to treat various bacterial infections, including urinary tract infections, respiratory tract infections, and sexually transmitted infections. Here, we will delve into the market dynamics and financial trajectory of Suprax.

Market Size and Growth

The cefixime market, which includes Suprax, has been experiencing steady growth. As of 2023, the cefixime market size was valued at USD 1,200 million and is projected to reach USD 1,850 million by 2031, growing at a CAGR of 4.9% during the forecast period 2024-2031[4].

Drivers of Market Growth

Several factors are driving the growth of the Suprax market:

Increasing Prevalence of Bacterial Infections

The rising incidence of bacterial infections globally, particularly in urban and developing regions, is a key driver. Factors such as urbanization, antibiotic resistance, and poor healthcare facilities contribute to this increase[4].

Growing Awareness and Healthcare Infrastructure

Increasing awareness among healthcare providers and patients about the importance of effective treatment options for bacterial infections further propels market growth. Emerging economies, especially in Asia-Pacific, Latin America, and Africa, are enhancing their healthcare infrastructure, which expands the market for Suprax[4].

Research and Development

Pharmaceutical companies are investing heavily in R&D to develop innovative formulations and delivery mechanisms for cefixime, which helps in differentiating their products in a competitive market[4].

Regional Insights

The market for Suprax is segmented across various regions, each with its unique characteristics:

North America

North America, including the U.S. and Canada, is a significant market due to the high prevalence of bacterial infections and advanced healthcare facilities. Robust regulatory frameworks ensure high-quality standards in pharmaceuticals, leading to higher consumption of Suprax[4].

Europe

Countries like Germany, France, and the UK contribute significantly to the market due to high healthcare expenditure and stringent antimicrobial stewardship programs aimed at reducing antibiotic resistance[4].

Asia-Pacific

This region represents a high-growth market driven by rising population density, escalating healthcare needs, and improving access to medicines. Countries like India and China are witnessing an upsurge in Suprax prescriptions[4].

Middle East and Africa, Latin America

These regions face unique challenges but are gradually increasing their share in the market, propelled by initiatives aimed at enhancing healthcare accessibility and an upsurge in infectious diseases[4].

Competitive Landscape

The market for Suprax is highly competitive, with several key players:

Generic Versions

Numerous manufacturers offer generic versions of cefixime, leading to price wars and reduced profit margins. Companies like Lupin Pharmaceuticals have launched generic versions of Suprax, which has impacted the market dynamics[3].

Lupin Pharmaceuticals

Lupin, for instance, has been a significant player in the U.S. generics market, including the launch of generic versions of Suprax. In 2012, Lupin's US Formulations revenues, including IP income, grew by 22%, with the generics business contributing 72% of total U.S. sales[2].

Financial Performance

The financial performance of companies involved in the Suprax market is influenced by several factors:

Revenue Growth

Lupin, a major player, has shown strong revenue growth. For example, in FY 2012, Lupin's net sales grew by 22% to approximately USD 1.4 billion, with EBITDA margins increasing by 22%[2].

R&D Investments

Significant investments in R&D are crucial for maintaining market share. For instance, Lupin's R&D expenses have been substantial, with the company focusing on filing ANDAs, DMFs, and conducting clinical trials to stay competitive[3].

Challenges and Restraints

Despite the growth, the Suprax market faces several challenges:

Antimicrobial Resistance

The rising issue of antimicrobial resistance (AMR) poses a significant restraint. As bacterial strains evolve and develop resistance to common antibiotics, including cefixime, healthcare professionals may hesitate to prescribe it, leading to reduced demand[4].

Regulatory and Quality Issues

Drug recalls due to regulatory issues can hamper market growth. For example, recalls of cephalosporin drugs due to CGMP deviations have been reported in the past[1].

Key Takeaways

• The cefixime market, including Suprax, is expected to grow at a CAGR of 4.9% from 2024 to 2031.
• Increasing prevalence of bacterial infections and growing healthcare infrastructure in emerging economies drive market growth.
• North America and Europe are significant markets due to advanced healthcare facilities and stringent regulatory frameworks.
• Asia-Pacific represents a high-growth region driven by rising population density and improving healthcare access.
• The market is highly competitive, with numerous generic versions available, leading to price wars and reduced profit margins.
• Significant R&D investments are necessary to differentiate products and maintain market share.

FAQs

Q1: What is the projected market size of cefixime by 2031? The cefixime market is projected to reach USD 1,850 million by 2031[4].

Q2: Which regions are driving the growth of the cefixime market? Emerging economies in Asia-Pacific, Latin America, and Africa, along with established markets in North America and Europe, are driving the growth[4].

Q3: What are the main drivers of the cefixime market? The main drivers include the increasing prevalence of bacterial infections, growing awareness and healthcare infrastructure, and significant R&D investments[4].

Q4: How does antimicrobial resistance impact the cefixime market? Antimicrobial resistance can lead to reduced demand for cefixime as healthcare professionals may hesitate to prescribe it for infections that were previously treatable[4].

Q5: Which companies are significant players in the cefixime market? Companies like Lupin Pharmaceuticals, which have launched generic versions of Suprax, are significant players in the market[2][3].

Cited Sources:

1. Coherent Market Insights Analysis (2019) - Cephalosporin Drugs Market - Share, Size and Industry Analysis.
2. Lupin - BSE - Annual Report 2012.
3. Lupin - BSE - Investing for Growth, Annual Report 2005.
4. Verified Market Research - Cefixime Market Size, Scope, Growth, Trends and Forecast.