ZITHROMAX Drug Patent Profile

Which patents cover Zithromax, and what generic alternatives are available?

Zithromax is a drug marketed by Pfizer and is included in seven NDAs.

The generic ingredient in ZITHROMAX is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zithromax

A generic version of ZITHROMAX was approved as azithromycin by PLIVA on November 14^th, 2005.

Summary for ZITHROMAX

US Patents:	0
Applicants:	1
NDAs:	7
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	105
Patent Applications:	3,137
Drug Prices:	Drug price information for ZITHROMAX
Drug Sales Revenues:	Drug sales revenues for ZITHROMAX
What excipients (inactive ingredients) are in ZITHROMAX?	ZITHROMAX excipients list
DailyMed Link:	ZITHROMAX at DailyMed

See drug prices for ZITHROMAX

See drug sales revenues for ZITHROMAX

Recent Clinical Trials for ZITHROMAX

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

Sponsor	Phase
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit	Phase 2/Phase 3
Mahidol Oxford Tropical Medicine Research Unit	Phase 2/Phase 3
Brigham and Women's Hospital	Phase 1

See all ZITHROMAX clinical trials

Pharmacology for ZITHROMAX

Drug Class

Macrolide Antimicrobial

US Patents and Regulatory Information for ZITHROMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	ZITHROMAX	azithromycin	CAPSULE;ORAL	050670-001	Nov 1, 1991		DISCN	Yes	No
Pfizer	ZITHROMAX	azithromycin	TABLET;ORAL	050784-001	May 24, 2002	AB	RX	Yes	No
Pfizer	ZITHROMAX	azithromycin	FOR SUSPENSION;ORAL	050710-002	Oct 19, 1995	AB	RX	Yes	Yes
Pfizer	ZITHROMAX	azithromycin	TABLET;ORAL	050730-001	Jun 12, 1996		DISCN	Yes	No

Expired US Patents for ZITHROMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZITHROMAX	azithromycin	TABLET;ORAL	050730-001	Jun 12, 1996
Pfizer	ZITHROMAX	azithromycin	FOR SUSPENSION;ORAL	050710-002	Oct 19, 1995
Pfizer	ZITHROMAX	azithromycin	INJECTABLE;INJECTION	050733-001	Jan 30, 1997
Pfizer	ZITHROMAX	azithromycin	FOR SUSPENSION;ORAL	050693-001	Sep 28, 1994

International Patents for ZITHROMAX

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

Country	Patent Number	Title	Estimated Expiration
Japan	H0631300
Spain	2037833
European Patent Office	0298650	AZITHROMYCIN DIHYDRATE
China	1030422

Market Dynamics and Financial Trajectory of Azithromycin (Zithromax)

Introduction to Azithromycin (Zithromax)

Azithromycin, commonly known by its brand name Zithromax, is a widely used antibiotic effective against a broad spectrum of bacterial infections. Here, we delve into the market dynamics and financial trajectory of azithromycin, highlighting key trends, drivers, and regional performances.

Global Market Size and Growth

The global azithromycin market has demonstrated robust growth and is expected to continue this trend. As of 2024, the market size was valued at USD 7.77 billion and is projected to reach USD 11.92 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 5.50% during the forecast period of 2025 to 2032[1][4].

Key Drivers of Market Growth

Increasing Prevalence of Bacterial Infections

The rising global prevalence of respiratory infections, such as pneumonia and tuberculosis, is a significant driver of the azithromycin market. The COVID-19 pandemic has further amplified the demand for azithromycin, particularly in treating bacterial respiratory infections[1].

Effectiveness and Safety Profile

Azithromycin's effectiveness and safety profile have made it a preferred choice among healthcare professionals. Its use in combination with other drugs for treating severe cases of pneumonia and bronchitis has gained popularity, contributing to market growth[1].

Emergence of Antibiotic-Resistant Bacteria

The increasing emergence of antibiotic-resistant bacteria has pushed the adoption of advanced azithromycin formulations, further boosting the market. This trend is expected to continue as the need for effective antibiotics remains high[1].

Regional Market Analysis

Asia-Pacific

The Asia-Pacific region, particularly China, is expected to dominate the azithromycin market. China's strong healthcare infrastructure, large population, and the presence of major pharmaceutical players contribute to its significant market share. The region's robust biopharmaceutical sector and favorable government policies for drug manufacturing and development also support market growth[1][4].

North America

North America is another key region for the azithromycin market, driven by the rising healthcare infrastructure, increasing demand for advanced medical treatments, and a large population. The United States, in particular, sees azithromycin as one of the most commonly prescribed medications, contributing to the region's significant revenue share[1][4].

Europe

Europe also exhibits a positive market trend for azithromycin. The region's demand is supported by steady pharmaceutical sector demand and improved consumer sentiment. However, factors such as high logistics costs and economic uncertainties can cause price fluctuations[3].

Market Segmentation

By Source

The azithromycin market is segmented into in-house and contract manufacturing organizations. This segmentation highlights the diverse production strategies employed by pharmaceutical companies to meet the growing demand for azithromycin[1].

By Type

Azithromycin is available in various forms, including oral, injection, and ophthalmic. Each type caters to different application needs, contributing to the market's overall growth[1].

By Application

The primary applications of azithromycin include treating bacterial infections, Mycobacterium Avium Complex (MAC) infections, and other bacterial diseases. The expanding application scope of azithromycin for different indications is a key factor driving market revenue growth[1][4].

By Demographic

The market is segmented by demographic into children and adults. The demand for azithromycin is significant across both demographics, driven by the prevalence of bacterial infections in various age groups[1].

By End-Users

The end-users of azithromycin include clinics, hospitals, and other healthcare facilities. The growing need for effective antibiotics in these settings drives the market forward[1].

By Distribution Channel

The distribution channels for azithromycin include hospital pharmacies, retail pharmacies, and online pharmacies. The convenience and accessibility offered by these channels contribute to the market's expansion[1].

Price Trends and Forecast

Global Price Dynamics

Azithromycin prices have exhibited oscillating trends globally. In Europe and North America, prices have been influenced by factors such as steady pharmaceutical demand, logistical challenges, and economic uncertainties. In Asia, particularly in India, the demand has been driven by the disease season and high production costs[3].

Regional Price Variations

• Europe: Prices initially rose due to steady demand and improved consumer sentiment but later declined as demand fundamentals weakened[3].
• North America: The US market saw firm prices initially due to supply chain constraints but later declined due to weakening demand and economic uncertainties[3].
• Asia: Prices rose consistently in India due to high demand and production costs, particularly during the disease season[3].

Analyst Insights

Analysts predict that azithromycin prices will continue to fluctuate in the coming months due to current economic scenarios and pricing fundamentals. The ongoing discussions between the US administration and global pharmaceutical giants are expected to impact global markets significantly[3].

Financial Performance of Key Players

Pfizer

While Pfizer's overall revenue has seen significant fluctuations, particularly due to the decline in revenues from Comirnaty and Paxlovid, the company's biopharmaceutical business segment remains strong. Excluding contributions from Comirnaty and Paxlovid, Pfizer's revenues grew 7% operationally in 2023. This indicates a stable financial foundation for pharmaceuticals like azithromycin, even amidst broader market changes[2].

Regulatory and Research Activities

Regulatory Framework

The market growth of azithromycin is also supported by regulatory approvals and a favorable regulatory framework. Increasing product approvals from regulatory bodies and investments in research activities are expected to contribute to the market's expansion[4].

Research and Development

The pharmaceutical sector's rapid progress and growing investment in drug research and development are crucial for the azithromycin market. These activities help in the development of new formulations and applications, further driving market growth[4].

Conclusion

The azithromycin market is poised for significant growth driven by the increasing prevalence of bacterial infections, its effectiveness and safety profile, and the emergence of antibiotic-resistant bacteria. Regional markets, particularly in Asia-Pacific and North America, are expected to dominate the market. Price trends will continue to fluctuate based on economic and logistical factors, but overall, the market outlook remains positive.

Key Takeaways

• Market Growth: The global azithromycin market is expected to grow from USD 7.77 billion in 2024 to USD 11.92 billion by 2032.
• Key Drivers: Rising prevalence of bacterial infections, effectiveness and safety profile, and emergence of antibiotic-resistant bacteria.
• Regional Performance: Asia-Pacific and North America are key regions driving market growth.
• Price Trends: Prices will continue to fluctuate due to economic and logistical factors.
• Regulatory Support: Favorable regulatory framework and increasing product approvals support market growth.

FAQs

Q: What is the current market size of the global azithromycin market? A: The global azithromycin market size was valued at USD 7.77 billion in 2024[1].

Q: What is the expected CAGR of the azithromycin market from 2025 to 2032? A: The azithromycin market is expected to grow at a CAGR of 5.50% from 2025 to 2032[1].

Q: Which regions are expected to dominate the azithromycin market? A: Asia-Pacific and North America are expected to dominate the azithromycin market[1][4].

Q: What are the primary drivers of the azithromycin market growth? A: The primary drivers include the rising prevalence of bacterial infections, the effectiveness and safety profile of azithromycin, and the emergence of antibiotic-resistant bacteria[1].

Q: How do economic and logistical factors influence azithromycin prices? A: Economic and logistical factors such as supply chain constraints, demand fundamentals, and production costs can cause fluctuations in azithromycin prices[3].

Sources

1. Data Bridge Market Research - Global Azithromycin Market – Industry Trends and Forecast to 2030
2. Pfizer - Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024
3. Procurement Resource - Azithromycin Price Trend and Forecast
4. Reports and Data - Azithromycin Market Size, Share & Scope