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Last Updated: March 11, 2025

AZITHROMYCIN Drug Patent Profile


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When do Azithromycin patents expire, and what generic alternatives are available?

Azithromycin is a drug marketed by 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, Alembic, Apotex Corp, Aurobindo Pharma Usa, Bionpharma, Cspc Ouyi, Extrovis, Lupin Ltd, Pharmobedient, Strides Pharma, Sunshine, Teva, Yung Shin Pharm, and Zydus Pharms. and is included in sixty-three NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Azithromycin

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

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Drug patent expirations by year for AZITHROMYCIN
Drug Prices for AZITHROMYCIN

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Drug Sales Revenue Trends for AZITHROMYCIN

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Recent Clinical Trials for AZITHROMYCIN

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SponsorPhase
Mahidol Oxford Tropical Medicine Research UnitPhase 2/Phase 3
Lao-Oxford-Mahosot Hospital Wellcome Trust Research UnitPhase 2/Phase 3
Medical University of ViennaN/A

See all AZITHROMYCIN clinical trials

Pharmacology for AZITHROMYCIN
Medical Subject Heading (MeSH) Categories for AZITHROMYCIN
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
Zydus Pharms AZITHROMYCIN azithromycin TABLET;ORAL 213275-001 Apr 11, 2023 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bionpharma AZITHROMYCIN azithromycin TABLET;ORAL 210000-001 Feb 26, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Alembic AZITHROMYCIN azithromycin TABLET;ORAL 211791-001 Jan 28, 2020 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Cspc Ouyi AZITHROMYCIN azithromycin TABLET;ORAL 207566-001 Sep 24, 2018 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sandoz AZITHROMYCIN azithromycin TABLET;ORAL 065212-001 Nov 14, 2005 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Chartwell Rx AZITHROMYCIN azithromycin TABLET;ORAL 065405-001 Feb 11, 2008 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Extrovis AZITHROMYCIN azithromycin TABLET;ORAL 065366-001 May 30, 2007 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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