Azithromycin - Generic Drug Details

What are the generic drug sources for azithromycin and what is the scope of freedom to operate?

Azithromycin is the generic ingredient in five branded drugs marketed by Pfizer, Pf Prism Cv, Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma Llc, Hainan Poly, Pliva, Sandoz, Taro, Teva Pharms, Zydus Lifesciences, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Norvium Bioscience, Rising, Slate Run Pharma, Sun Pharm Inds Ltd, Teva Parenteral, Thea Pharma, Alembic, Apotex Corp, Aurobindo Pharma Usa, Bionpharma, Cspc Ouyi, Lupin Ltd, Pharmobedient, Strides Pharma, Sunshine, Teva, Yung Shin Pharm, and Zydus Pharms, and is included in seventy-three NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Azithromycin has fifty-one patent family members in forty-three countries.

There are thirty-two drug master file entries for azithromycin. Sixty-seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for azithromycin

International Patents:	51
US Patents:	2
Tradenames:	5
Applicants:	35
NDAs:	73
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	67
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	570
Patent Applications:	6,913
Drug Prices:	Drug price trends for azithromycin
Drug Sales Revenues:	Drug sales revenues for azithromycin
What excipients (inactive ingredients) are in azithromycin?	azithromycin excipients list
DailyMed Link:	azithromycin at DailyMed

See drug prices for azithromycin

See drug sales revenues for azithromycin

Recent Clinical Trials for azithromycin

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

Sponsor	Phase
Mahidol Oxford Tropical Medicine Research Unit	Phase 2/Phase 3
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit	Phase 2/Phase 3
Medical University of Vienna	N/A

See all azithromycin clinical trials

Generic filers with tentative approvals for AZITHROMYCIN

Applicant	Application No.	Strength	Dosage Form
		1%	SOLUTION; OPHTHALMIC
		EQ 200MG BASE/5ML	FOR SUSPENSION;ORAL
		EQ 100MG BASE/5ML	FOR SUSPENSION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for azithromycin

Drug Class

Macrolide Antimicrobial

Medical Subject Heading (MeSH) Categories for azithromycin

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for azithromycin

J01FA	Macrolides
J01F	MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for AZITHROMYCIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AZASITE	Ophthalmic Solution	azithromycin	1%	050810	1	2011-03-03

US Patents and Regulatory Information for azithromycin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pliva	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	065246-001	Jul 5, 2006	AB	RX	No	No
Strides Pharma	AZITHROMYCIN	azithromycin	TABLET;ORAL	215773-001	Jul 12, 2022	AB	RX	No	No
Pliva	AZITHROMYCIN	azithromycin	TABLET;ORAL	065218-001	Nov 14, 2005	AB	RX	No	Yes
Sandoz	AZITHROMYCIN	azithromycin	TABLET;ORAL	065209-001	Nov 14, 2005	AB	RX	No	No
Pliva	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	065246-002	Jul 5, 2006	AB	RX	No	No
Amneal	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	205666-001	Jul 19, 2018	AB	RX	No	No

Expired US Patents for azithromycin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZITHROMAX	azithromycin	FOR SUSPENSION;ORAL	050710-001	Oct 19, 1995	6,268,489
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	6,861,411
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	6,159,458
Pfizer	ZITHROMAX	azithromycin	FOR SUSPENSION;ORAL	050693-001	Sep 28, 1994	6,268,489
Pf Prism Cv	ZMAX	azithromycin	FOR SUSPENSION, EXTENDED RELEASE;ORAL	050797-001	Jun 10, 2005	6,068,859
Pfizer	ZITHROMAX	azithromycin	TABLET;ORAL	050711-001	Jul 18, 1996	6,268,489

International Patents for azithromycin

Country	Patent Number	Title	Estimated Expiration
Cyprus	1108486
Costa Rica	7500	FORMAS DE DOSIFICACION DE AZITROMICIDA CON EFECTOS SECUNDARIOS REDUCIDOS
Australia	2004216676	Azithromycin dosage forms with reduced side effects
Ecuador	SP045351	FORMAS DE DOSIFICACIÓN DE AZITROMICINA CON EFECTOS SECUNDARIOS REDUCIDOS
Georgia, Republic of	P20074056	AZITHROMYCIN DOSAGE FORMS WITH REDUCED SIDE EFFECTS
Poland	379984	Postacie dawkowane azytromycyny o zmniejszonym działaniu ubocznym (AZITHROMYCIN DOSAGE FORMS WITH REDUCED SIDE EFFECTS)

Azithromycin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Azithromycin

Market Size and Growth Projections

The global azithromycin market is poised for significant growth, driven by several key factors. As of 2022, the market was valued at USD 6,976.17 million and is projected to reach USD 10,706.23 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5.5% during the forecast period[1].

Drivers of Market Growth

Increasing Prevalence of Respiratory Tract Infections

The high incidence of respiratory tract infections, estimated at around 5 billion cases per year, is a major driver for the azithromycin market. Azithromycin's effectiveness in treating these infections makes it a preferred choice, contributing to its market growth[1].

Rising Awareness About Azithromycin

Increased awareness about the benefits of azithromycin, thanks to marketing campaigns and recommendations from healthcare professionals, has led to a rise in its use. This heightened awareness is driving both prescription and over-the-counter sales, further boosting market growth[1].

Growing Demand from Emerging Markets

Emerging markets such as China, India, Brazil, and Mexico are experiencing a surge in demand for azithromycin due to the increasing incidence of infectious diseases and expanding healthcare infrastructure. This presents a significant opportunity for drug manufacturers[1].

Challenges and Restraints

High Cost and Regulatory Hurdles

The high cost of azithromycin and stringent government standards for approval, particularly due to severe side effects, can hamper market growth. Additionally, the expiration of patent protection in major geographies could lead to increased competition from generic players, although this also presents opportunities for market expansion[1].

Supply Chain Disruptions

Global supply chain issues, exacerbated by factors such as the Golden Week holiday in China and labor strikes at U.S. ports, can lead to delays in distribution and a temporary decline in azithromycin availability. These disruptions are likely to drive prices higher and create supply-demand imbalances[2].

Geopolitical Tensions and Economic Factors

Geopolitical tensions, such as the ongoing conflict in the Middle East, can impact India’s pharmaceutical sector, a critical supplier of Active Pharmaceutical Ingredients (APIs) to the U.S. and European markets. Rising oil prices and trade disruptions can increase manufacturing and transportation costs, further straining supply chains and driving up prices[2].

Regional Market Analysis

Asia Pacific

The Asia Pacific region is anticipated to witness lucrative growth due to rising disposable income and improving healthcare infrastructure, especially in developing countries like India. The availability of azithromycin as both generic and branded drugs, along with favorable government policies, is expected to drive market expansion in this region[1][4].

North America

North America is expected to account for the largest revenue share, driven by the rising incidence of bacterial infections, increasing number of product approvals, and significant investments in pharmaceutical and biotechnology research and development. Azithromycin is one of the most commonly prescribed medications in the United States, contributing to the region's market dominance[4].

Price Trends and Forecast

Current Price Dynamics

Azithromycin prices are forecasted to rise globally in October 2024, driven by a surge in demand from end-user industries, persistent supply chain issues, and limited availability. Market participants are restocking inventories ahead of the new quarter, which could further influence the price trajectory[2].

Future Price Projections

The pricing trajectory of azithromycin is anticipated to exhibit fluctuations in the forthcoming months, influenced by economic conditions, supply chain dynamics, and regulatory interventions. Despite these challenges, the market is expected to sustain a stable growth trajectory due to azithromycin's proven efficacy, convenience, and cost-effectiveness[3].

Economic Impact and Cost-Effectiveness

Cost of Care

Studies have shown that azithromycin is associated with lower costs compared to other antibiotics. For instance, a 3- or 5-day course of azithromycin was found to be more cost-effective than a 10-day course of roxithromycin, with lower total costs of care and reduced time absent from work[5].

Compliance and Symptom Resolution

Azithromycin also offers better compliance and faster resolution of symptoms. Patients prescribed azithromycin for 3 or 5 days showed significantly better compliance and a longer symptom-free period compared to those treated with roxithromycin[5].

Industry and Market Players

Major Players

The azithromycin market includes major players such as Pfizer, Sanofi, and Takeda. These companies have announced plans to increase prices on several drugs, including azithromycin, in response to regulatory initiatives and market dynamics[3].

Generic and Branded Drugs

The availability of azithromycin as both generic and branded drugs is a significant factor in its market growth. Generic alternatives are expected to increase competition, but the brand-name drugs continue to hold a strong market position due to their proven efficacy and trust among healthcare professionals[1][4].

Key Takeaways

• The global azithromycin market is expected to grow from USD 6,976.17 million in 2022 to USD 10,706.23 million by 2030, with a CAGR of 5.5%.
• Key drivers include the increasing prevalence of respiratory tract infections, rising awareness about azithromycin, and growing demand from emerging markets.
• Challenges such as high costs, regulatory hurdles, and supply chain disruptions are expected to impact market growth.
• The Asia Pacific and North America regions are anticipated to be major contributors to the market growth.
• Azithromycin is cost-effective and offers better compliance and faster symptom resolution compared to other antibiotics.

Frequently Asked Questions (FAQs)

Q: What is the projected market size of azithromycin by 2030? A: The global azithromycin market is expected to reach USD 10,706.23 million by 2030[1].

Q: What are the main drivers of the azithromycin market growth? A: The main drivers include the increasing prevalence of respiratory tract infections, rising awareness about azithromycin, and growing demand from emerging markets[1].

Q: How do supply chain disruptions affect azithromycin prices? A: Supply chain disruptions, such as those caused by the Golden Week holiday in China and labor strikes at U.S. ports, can lead to delays in distribution, temporary declines in availability, and higher prices[2].

Q: Which regions are expected to contribute significantly to the azithromycin market growth? A: The Asia Pacific and North America regions are anticipated to be major contributors to the market growth due to factors such as rising disposable income, improving healthcare infrastructure, and high incidence of bacterial infections[1][4].

Q: Is azithromycin cost-effective compared to other antibiotics? A: Yes, azithromycin is associated with lower costs of care, better compliance, and faster resolution of symptoms compared to other antibiotics like roxithromycin[5].

Cited Sources:

1. Data Bridge Market Research - Global Azithromycin Market – Industry Trends and Forecast to 2030
2. ChemAnalyst - Global Azithromycin Prices Set to Climb in October Amid Rising Demand and Supply Chain Challenges
3. ChemAnalyst - Global Azithromycin Market Showed Diverse Trends in 2023 with a Positive Outlook Ahead
4. Reports and Data - Azithromycin Market Size, Share & Scope
5. PubMed - A prospective comparison of azithromycin versus roxithromycin