CLINICAL TRIALS PROFILE FOR ZITHROMAX

505(b)(2) Clinical Trials for Zithromax

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00694694 ↗	Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria.	Completed	National Institute for Medical Research, Tanzania	Phase 3	2008-06-01	This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.
New Combination	NCT00694694 ↗	Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria.	Completed	London School of Hygiene and Tropical Medicine	Phase 3	2008-06-01	This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.

All Clinical Trials for Zithromax

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00035347 ↗	Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia	Completed	Pfizer	Phase 4	2001-01-01	A trial in which patients over 18 years of age who are hospitalized with community acquired pneumonia and are otherwise eligible for entry into the study are randomly selected to receive one of two treatment regimens. After written informed consent is obtained, patients will receive one of the following two treatment regimens: 1) intravenous administration of azithromycin and ceftriaxone followed by azithromycin tablets, or 2) intravenous administration of levofloxacin followed by levofloxacin tablets. At least four study visits are normally conducted up to approximately one month after starting therapy. The objective of this study is to compare the safety and efficacy of the two treatment regimens.
NCT00137007 ↗	Zithromax EV in Community-Acquired Pneumonia (CAP)	Completed	Pfizer	Phase 4	2003-11-01	The intravenous (IV) regimen containing azithromycin (Zithromax) plus ampicillin-sulbactam is consistent with current guidelines for the treatment of CAP. In fact the International guidelines for the treatment of CAP in hospitalised patients suggests the use of a combination between a b-lactam and a macrolide. This trial will allow investigators to evaluate the efficacy of azithromycin plus ampicillin-sulbactam in the treatment of hospitalized subjects with community acquired pneumonia. In addition, this trial will allow investigators to evaluate the safety and toleration of combination therapy.
NCT00237445 ↗	Study Comparing the Clinical Efficacy and Health Outcomes of Outpatients With Mild to Moderate Community-Acquired Pneumonia (CAP) Treated With Either Telithromycin Once Daily for 7 Days, or Azithromycin Once Daily for 5 Days	Terminated	Sanofi	Phase 4	2005-11-01	A multinational, multicenter, randomized, double-blind, study in areas of high pneumococcal resistance comparing the clinical efficacy and health outcomes of outpatients with mild to moderate Community-Acquired Pneumonia (CAP) treated with either telithromycin once daily for 7 days, or azithromycin once daily for 5 days
NCT00266851 ↗	AZMATICS: AZithroMycin/Asthma Trial In Community Settings	Completed	American Academy of Family Physicians	Phase 3	2006-01-01	The purpose of this study is to assess the effectiveness of the azalide macrolide azithromycin in adults with persistent asthma. Research Question: Will a 12-week treatment with the antibiotic, azithromycin, result in a statistically significant and clinically meaningful improvement in overall asthma symptoms and other patient-oriented asthma outcomes one year after initiation of treatment of adult primary care patients with asthma? Experimental Design: The investigators propose a one-year randomized, placebo-controlled, blinded (investigator, patient, data collector, data analyst) trial of 12 weekly doses of azithromycin/placebo as adjunctive therapy (in addition to usual care) along with a parallel observational cohort who will participate 'open label' in 100 adult asthma patients recruited from practice-based research networks (e.g., Wisconsin Research and Education Network (WREN) and others). This "practical clinical trial" will (1) enroll a representative sample of asthma patients encountered in the practices of primary care physicians, (2) employ standard clinical trial methodology to ensure internally valid results and (3) measure outcomes important to patients, so that the results will be valid and applicable to the kinds of asthma patients encountered by family physicians and other primary care providers. Active study sites - - Wisconsin: Augusta, Cross Plains, La Crosse, Marshfield, Milwaukee, Madison, - Mauston, Rice Lake, Tomah, Wausau - Colorado: Monument - Illinois: Peoria - Nevada: Reno - North Carolina: Granite Falls - North Dakota: Minot - Ohio: Cleveland, Berea - Oklahoma: Ardmore, Claremore, Edmond, Lawton, Oklahoma City, Stroud, Tulsa, Weatherford - Rhode Island: East Providence
NCT00266851 ↗	AZMATICS: AZithroMycin/Asthma Trial In Community Settings	Completed	Dean Foundation	Phase 3	2006-01-01	The purpose of this study is to assess the effectiveness of the azalide macrolide azithromycin in adults with persistent asthma. Research Question: Will a 12-week treatment with the antibiotic, azithromycin, result in a statistically significant and clinically meaningful improvement in overall asthma symptoms and other patient-oriented asthma outcomes one year after initiation of treatment of adult primary care patients with asthma? Experimental Design: The investigators propose a one-year randomized, placebo-controlled, blinded (investigator, patient, data collector, data analyst) trial of 12 weekly doses of azithromycin/placebo as adjunctive therapy (in addition to usual care) along with a parallel observational cohort who will participate 'open label' in 100 adult asthma patients recruited from practice-based research networks (e.g., Wisconsin Research and Education Network (WREN) and others). This "practical clinical trial" will (1) enroll a representative sample of asthma patients encountered in the practices of primary care physicians, (2) employ standard clinical trial methodology to ensure internally valid results and (3) measure outcomes important to patients, so that the results will be valid and applicable to the kinds of asthma patients encountered by family physicians and other primary care providers. Active study sites - - Wisconsin: Augusta, Cross Plains, La Crosse, Marshfield, Milwaukee, Madison, - Mauston, Rice Lake, Tomah, Wausau - Colorado: Monument - Illinois: Peoria - Nevada: Reno - North Carolina: Granite Falls - North Dakota: Minot - Ohio: Cleveland, Berea - Oklahoma: Ardmore, Claremore, Edmond, Lawton, Oklahoma City, Stroud, Tulsa, Weatherford - Rhode Island: East Providence
NCT00266851 ↗	AZMATICS: AZithroMycin/Asthma Trial In Community Settings	Completed	Pfizer	Phase 3	2006-01-01	The purpose of this study is to assess the effectiveness of the azalide macrolide azithromycin in adults with persistent asthma. Research Question: Will a 12-week treatment with the antibiotic, azithromycin, result in a statistically significant and clinically meaningful improvement in overall asthma symptoms and other patient-oriented asthma outcomes one year after initiation of treatment of adult primary care patients with asthma? Experimental Design: The investigators propose a one-year randomized, placebo-controlled, blinded (investigator, patient, data collector, data analyst) trial of 12 weekly doses of azithromycin/placebo as adjunctive therapy (in addition to usual care) along with a parallel observational cohort who will participate 'open label' in 100 adult asthma patients recruited from practice-based research networks (e.g., Wisconsin Research and Education Network (WREN) and others). This "practical clinical trial" will (1) enroll a representative sample of asthma patients encountered in the practices of primary care physicians, (2) employ standard clinical trial methodology to ensure internally valid results and (3) measure outcomes important to patients, so that the results will be valid and applicable to the kinds of asthma patients encountered by family physicians and other primary care providers. Active study sites - - Wisconsin: Augusta, Cross Plains, La Crosse, Marshfield, Milwaukee, Madison, - Mauston, Rice Lake, Tomah, Wausau - Colorado: Monument - Illinois: Peoria - Nevada: Reno - North Carolina: Granite Falls - North Dakota: Minot - Ohio: Cleveland, Berea - Oklahoma: Ardmore, Claremore, Edmond, Lawton, Oklahoma City, Stroud, Tulsa, Weatherford - Rhode Island: East Providence
NCT00266851 ↗	AZMATICS: AZithroMycin/Asthma Trial In Community Settings	Completed	University of Wisconsin, Madison	Phase 3	2006-01-01	The purpose of this study is to assess the effectiveness of the azalide macrolide azithromycin in adults with persistent asthma. Research Question: Will a 12-week treatment with the antibiotic, azithromycin, result in a statistically significant and clinically meaningful improvement in overall asthma symptoms and other patient-oriented asthma outcomes one year after initiation of treatment of adult primary care patients with asthma? Experimental Design: The investigators propose a one-year randomized, placebo-controlled, blinded (investigator, patient, data collector, data analyst) trial of 12 weekly doses of azithromycin/placebo as adjunctive therapy (in addition to usual care) along with a parallel observational cohort who will participate 'open label' in 100 adult asthma patients recruited from practice-based research networks (e.g., Wisconsin Research and Education Network (WREN) and others). This "practical clinical trial" will (1) enroll a representative sample of asthma patients encountered in the practices of primary care physicians, (2) employ standard clinical trial methodology to ensure internally valid results and (3) measure outcomes important to patients, so that the results will be valid and applicable to the kinds of asthma patients encountered by family physicians and other primary care providers. Active study sites - - Wisconsin: Augusta, Cross Plains, La Crosse, Marshfield, Milwaukee, Madison, - Mauston, Rice Lake, Tomah, Wausau - Colorado: Monument - Illinois: Peoria - Nevada: Reno - North Carolina: Granite Falls - North Dakota: Minot - Ohio: Cleveland, Berea - Oklahoma: Ardmore, Claremore, Edmond, Lawton, Oklahoma City, Stroud, Tulsa, Weatherford - Rhode Island: East Providence

Clinical Trial Conditions for Zithromax

Condition Name

Condition Name for Zithromax
Intervention	Trials
Trachoma	8
Healthy	7
Malaria	6
COVID-19	5

Condition MeSH

Condition MeSH for Zithromax
Intervention	Trials
Infections	13
Infection	11
Communicable Diseases	11
Malaria	8

Clinical Trial Locations for Zithromax

Trials by Country

Trials by Country for Zithromax
Location	Trials
United States	201
Canada	15
France	14
Australia	11
United Kingdom	8

Trials by US State

Trials by US State for Zithromax
Location	Trials
California	20
Maryland	12
Texas	9
Alabama	8
Illinois	8

Clinical Trial Progress for Zithromax

Clinical Trial Phase

Clinical Trial Phase for Zithromax
Clinical Trial Phase	Trials
Phase 4	34
Phase 3	17
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for Zithromax
Clinical Trial Phase	Trials
Completed	62
Recruiting	13
Not yet recruiting	9

Clinical Trial Sponsors for Zithromax

Sponsor Name

Sponsor Name for Zithromax
Sponsor	Trials
University of California, San Francisco	16
Pfizer	15
Bill and Melinda Gates Foundation	10

Sponsor Type

Sponsor Type for Zithromax
Sponsor	Trials
Other	212
Industry	35
NIH	11

ZITHROMAX (AZITHROMYCIN) CLINICAL TRIAL UPDATE AND MARKET ANALYSIS

Last updated: February 19, 2026

ZITHROMAX: CURRENT CLINICAL TRIAL LANDSCAPE

Zithromax, the brand name for azithromycin, is a macrolide antibiotic with a broad spectrum of activity. Its established therapeutic profile has led to its widespread use in treating bacterial infections. Current clinical development focuses on expanding its application into new indications and optimizing existing ones, often in combination therapies.

Ongoing Clinical Trials by Indication:

• Respiratory Tract Infections (RTIs): While Zithromax is a standard treatment for community-acquired pneumonia (CAP) and acute exacerbations of chronic bronchitis (AECS), ongoing trials investigate its efficacy in specific patient populations and against emerging resistant strains. Trials are also examining long-term prophylactic use in individuals with recurrent RTIs.
• Skin and Soft Tissue Infections (SSTIs): Zithromax continues to be evaluated for SSTIs, including impetigo and cellulitis. Research is exploring its role in preventing post-surgical infections in certain dermatological procedures.
• Sexually Transmitted Infections (STIs): Zithromax is a key component in the treatment of gonorrhea and chlamydia. Clinical studies are assessing optimal dosing regimens and its effectiveness in preventing transmission, particularly in high-prevalence settings. Trials are also investigating its role in the management of other STIs like syphilis, often in combination with other agents.
• Otitis Media (Middle Ear Infections): Zithromax is an alternative to first-line treatments for acute otitis media. Ongoing research aims to confirm its efficacy and safety in pediatric populations, especially in cases where amoxicillin resistance is a concern.
• Other Infections: Trials are underway or have recently concluded for less common indications, including Lyme disease (early and late stages), certain gastrointestinal infections (e.g., Helicobacter pylori eradication in combination regimens), and ocular infections like trachoma. The potential for azithromycin to modulate inflammation is also being explored in conditions beyond infectious diseases.

Key Areas of Clinical Investigation:

• Drug Combinations: A significant portion of Zithromax development involves its use in combination therapies. This includes pairing azithromycin with other antibiotics to achieve synergistic effects against resistant pathogens or with non-antibiotic agents to target inflammatory or other disease processes. For example, combinations are being studied for tuberculosis (TB) treatment, where azithromycin may improve treatment outcomes and shorten therapy duration.
• Resistance Patterns: Ongoing surveillance and clinical trials are crucial for monitoring the emergence of azithromycin resistance. Studies are identifying genetic mechanisms of resistance and evaluating the clinical impact of resistance on treatment failures. This informs prescribing guidelines and the development of strategies to preserve azithromycin's effectiveness.
• Novel Formulations and Delivery Systems: While not as prominent as indication expansion, research into novel formulations or delivery systems for azithromycin may emerge to improve patient adherence or target specific anatomical sites of infection more effectively.

ZITHROMAX: MARKET ANALYSIS AND PROJECTION

The market for azithromycin remains robust, driven by its broad-spectrum activity, favorable pharmacokinetic profile, and established safety record. However, increasing antibiotic resistance and the availability of newer therapeutic agents present challenges.

Current Market Position:

• Generics Dominate: The market is largely dominated by generic azithromycin due to the expiration of original patents. This leads to significant price competition and limits the profitability of the branded Zithromax.
• Key Indications: Primary market drivers are infections of the respiratory tract, skin and soft tissues, and sexually transmitted infections. The widespread use in primary care and public health programs, particularly for STIs, sustains high volume demand.
• Geographic Distribution: Demand is global, with significant consumption in North America, Europe, and Asia. Emerging economies represent growth opportunities due to increasing access to healthcare and a higher prevalence of infectious diseases.
• Competitive Landscape: Zithromax competes with other macrolides (e.g., clarithromycin, erythromycin), fluoroquinolones, and beta-lactam antibiotics. The emergence of resistance to macrolides is a growing concern that influences treatment decisions.

Market Size and Growth Projections:

• Estimated Market Size: The global azithromycin market was valued at approximately USD 1.5 billion in 2022. [1]
• Projected Growth: The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.5% to 4.5% over the next five years. This growth is primarily fueled by increasing incidence of bacterial infections, particularly in developing regions, and its continued use as a cost-effective treatment option. [2]
• Factors Influencing Growth:
  • Increasing prevalence of STIs: Public health initiatives and changing sexual behaviors contribute to a sustained demand for effective STI treatments.
  • Rising incidence of respiratory infections: Aging populations and environmental factors can lead to increased occurrences of pneumonia and bronchitis.
  • Cost-effectiveness: As a generic drug, azithromycin offers a compelling economic advantage compared to newer, branded antibiotics, making it a preferred choice for healthcare systems and payers.
  • Limited development of new macrolides: The pipeline for entirely new macrolide antibiotics has been relatively constrained, allowing existing agents like azithromycin to maintain a significant market share.
• Factors Limiting Growth:
  • Antibiotic Resistance: The rise of azithromycin-resistant bacteria is a significant threat, potentially leading to decreased efficacy and a shift towards alternative treatments in certain regions or for specific pathogens.
  • Competition from Newer Antibiotics: The development of novel antibiotics with broader spectrums of activity or improved resistance profiles poses a competitive threat.
  • Stricter Regulatory Scrutiny: Increased emphasis on antimicrobial stewardship may lead to more judicious use of broad-spectrum antibiotics like azithromycin, particularly for less severe infections.
  • Patent Expirations: The generic nature of the drug limits significant revenue growth from the originator brand.

Future Market Trends:

• Specialized Applications: Growth may be seen in niche indications where azithromycin's unique properties are beneficial, such as in combination therapies for complex or resistant infections.
• Global Health Initiatives: Continued investment in global health programs targeting infectious diseases will maintain demand, especially in low- and middle-income countries.
• Antimicrobial Stewardship Impact: The extent to which antimicrobial stewardship programs influence prescribing patterns for azithromycin will be a key determinant of future market dynamics. A balanced approach that preserves its utility while preventing overuse will be critical.
• Emergence of New Resistance Mechanisms: Ongoing monitoring and research into resistance will be vital. Should widespread resistance emerge rapidly, market share could decline faster than projected. Conversely, strategies to mitigate resistance could sustain its position.

ZITHROMAX: KEY STATISTICS

• Primary Active Ingredient: Azithromycin
• Drug Class: Macrolide Antibiotic
• Established Indications:
  • Community-acquired pneumonia (CAP)
  • Acute exacerbations of chronic obstructive pulmonary disease (AECOPD)
  • Acute bacterial sinusitis
  • Pharyngitis/tonsillitis
  • Uncomplicated skin and skin structure infections
  • Urethritis and cervicitis (due to Chlamydia trachomatis)
  • Genital ulcer disease (chancroid)
  • Acute otitis media
• Half-life: Approximately 68 hours in healthy individuals. [3] This long half-life allows for once-daily dosing and shorter treatment courses compared to some other antibiotics.
• Dosing Regimens: Typically administered for 3 or 5 days. For example, common regimens for CAP include 500 mg on day 1, followed by 250 mg on days 2-5. [4]
• Market Share (Azithromycin Segment): While specific market share data for Zithromax (as opposed to generic azithromycin) is proprietary, the azithromycin API market is highly competitive, with multiple global manufacturers. The branded Zithromax holds a diminishing share due to generic erosion.
• Key Competitors (Azithromycin Market): Teva Pharmaceutical Industries, Sandoz International GmbH, Mylan N.V. (now Viatris), and numerous other generic manufacturers.
• Regulatory Status: Approved by the U.S. Food and Drug Administration (FDA) in 1991. [5] Global regulatory approvals are widespread.

ZITHROMAX: PATENT LANDSCAPE

The original patent protection for azithromycin has long expired, leading to a genericized market. Future patent activity primarily revolves around new formulations, combination therapies, or novel uses that could grant additional market exclusivity.

Original Patent Expiration:

• The primary patents covering azithromycin itself have expired. The U.S. compound patent for azithromycin expired in 2007. [6] This opened the door for widespread generic competition.

Current Patent Activity Focus:

• New Indications: Patents are sought for the use of azithromycin in treating specific diseases or conditions not previously covered by existing patents. This often requires new clinical data demonstrating efficacy and safety for the novel indication.
• Combination Therapies: Patents may cover specific formulations or treatment regimens involving azithromycin in combination with other active pharmaceutical ingredients. These patents aim to protect the synergistic or additive benefits of the combined approach.
• Formulation Improvements: Novel drug delivery systems or formulations designed to improve bioavailability, patient compliance, stability, or to achieve targeted drug release can be patented. Examples include extended-release formulations or topical preparations.
• Manufacturing Processes: While less common for widely established drugs, patents can sometimes be granted for novel or significantly improved manufacturing processes that offer cost advantages or higher purity.

Challenges in Securing New Patents:

• "Obviousness" Standard: For azithromycin, demonstrating that a new use, formulation, or combination is non-obvious to a person skilled in the art is a significant hurdle. The extensive existing knowledge base around azithromycin makes this challenging.
• Prior Art: The vast amount of published research and clinical data on azithromycin constitutes significant prior art, which can be used to invalidate or limit the scope of new patent applications.
• Lengthy Development Cycles: Obtaining regulatory approval for new indications or formulations requires extensive clinical trials, which are costly and time-consuming. This investment needs to be weighed against the potential patent life remaining.

Key Takeaways

• Zithromax (azithromycin) is established in treating common bacterial infections, with ongoing research exploring new indications and combination therapies, particularly for complex or resistant infections.
• The azithromycin market is dominated by generics, projected to grow at a CAGR of 3.5-4.5%, driven by cost-effectiveness, global demand for STI and RTI treatments, and increasing healthcare access in emerging economies.
• Antibiotic resistance and competition from newer agents are the primary threats to market growth, necessitating ongoing vigilance and strategic positioning.
• Original patent protection has expired, with new patent opportunities focused on novel indications, combination therapies, and formulation improvements, facing significant challenges due to existing prior art and the "obviousness" standard.

Frequently Asked Questions

1. What are the most promising new indications for azithromycin currently under investigation? Ongoing research is exploring azithromycin's potential in combination therapies for tuberculosis, its role in managing certain inflammatory conditions beyond bacterial infections, and its efficacy in treating specific, less common STIs and dermatological infections.

2. How significantly is antibiotic resistance impacting the use and market trajectory of azithromycin? The emergence of azithromycin-resistant strains, particularly in pathogens like Streptococcus pneumoniae and Neisseria gonorrhoeae, is a critical concern. While azithromycin remains a valuable first-line agent for many conditions, resistance necessitates careful prescribing based on local susceptibility patterns and can lead to treatment failures, potentially influencing market share in highly affected regions.

3. What is the projected impact of antimicrobial stewardship programs on azithromycin sales? Antimicrobial stewardship programs aim to optimize antibiotic use. For azithromycin, this could translate to more targeted prescribing for indicated infections, potentially reducing its use for viral infections or less severe bacterial illnesses where other agents might suffice. The net impact will depend on the balance between appropriate use for necessary indications and avoidance of unnecessary prescriptions.

4. Are there any significant developments in novel formulations or delivery methods for azithromycin that could alter its market position? While the primary focus is on new indications and combinations, research into improved formulations for azithromycin is ongoing. Potential advancements could include enhanced oral bioavailability, sustained-release formulations for extended efficacy, or targeted delivery systems for specific anatomical sites. However, these are not currently major market disruptors.

5. Given the generic nature of azithromycin, what is the primary value proposition for its continued market presence and growth? The primary value proposition lies in its established efficacy, favorable safety profile, long half-life enabling convenient dosing, and crucially, its cost-effectiveness. This makes it an indispensable tool for healthcare systems globally, particularly in resource-limited settings and for high-volume public health initiatives like STI treatment.

Citations

[1] Grand View Research. (2023). Azithromycin Market Size, Share & Trends Analysis Report By Application (Respiratory Tract Infections, Skin and Soft Tissue Infections, STIs, Others), By Region, And Segment Forecasts, 2023-2030. [2] Mordor Intelligence. (2023). Azithromycin Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028). [3] FDA. (n.d.). Zithromax (azithromycin) Prescribing Information. Pfizer Inc. [4] UpToDate. (n.d.). Community-acquired pneumonia in adults: Treatment. [5] U.S. Food and Drug Administration. (n.d.). Drug Approvals Database. [6] U.S. Patent and Trademark Office. (Various Dates). Patent Records for Azithromycin Compound and Formulations.