Azithromycin Patent Expiration

Azithromycin was first introduced by Pfizer Chemicals Div Pfizer Inc in its drug Zithromax on Nov 1, 1991. Other drugs containing Azithromycin are Azithromycin, Azasite, Zmax. 35 different companies have introduced drugs containing Azithromycin.


Azithromycin Patents

Given below is the list of patents protecting Azithromycin, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Zmax US6984403 Azithromycin dosage forms with reduced side effects Feb 14, 2024

(Expired)

Pf Prism Cv
Zmax US7887844 Multiparticulate crystalline drug compositions having controlled release profiles Feb 14, 2024

(Expired)

Pf Prism Cv
Azasite US6239113 Topical treatment or prevention of ocular infections Mar 31, 2019

(Expired)

Thea Pharma
Azasite US6569443 Topical treatment or prevention of ocular infections Mar 31, 2019

(Expired)

Thea Pharma
Azasite US7056893 Topical treatment for prevention of ocular infections Mar 31, 2019

(Expired)

Thea Pharma
Azasite US6861411 Method of treating eye infections with azithromycin Nov 25, 2018

(Expired)

Thea Pharma
Zithromax US6268489 Azithromycin dihydrate Jul 31, 2018

(Expired)

Pfizer
Zithromax US6268489 Azithromycin dihydrate Jul 31, 2018

(Expired)

Pfizer
Zithromax US6268489 Azithromycin dihydrate Jul 31, 2018

(Expired)

Pfizer
Zmax US6268489 Azithromycin dihydrate Jul 31, 2018

(Expired)

Pf Prism Cv
Azasite US6159458 Sustained release ophthalmic compositions containing water soluble medicaments Nov 04, 2017

(Expired)

Thea Pharma
Zmax US6068859 Controlled-release dosage forms of Azithromycin May 30, 2017

(Expired)

Pf Prism Cv



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Azithromycin's patents.

Given below is the list recent legal activities going on the following patents of Azithromycin.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 13 Jul, 2022 US7887844
Payment of Maintenance Fee, 8th Year, Large Entity 16 Jul, 2018 US7887844
Patent Issue Date Used in PTA Calculation 15 Feb, 2011 US7887844
Recordation of Patent Grant Mailed 15 Feb, 2011 US7887844
Email Notification 27 Jan, 2011 US7887844
Issue Notification Mailed 26 Jan, 2011 US7887844
Dispatch to FDC 10 Jan, 2011 US7887844
Application Is Considered Ready for Issue 07 Jan, 2011 US7887844
Issue Fee Payment Verified 05 Jan, 2011 US7887844
Issue Fee Payment Received 05 Jan, 2011 US7887844


Azithromycin's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Azithromycin:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction Sanofi NA RECRUITING
(Sep 1, 2026)
PHASE3
Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants Assistance Publique - Hôpitaux de Paris NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
Roflumilast or Azithromycin to Prevent COPD Exacerbations Trial Johns Hopkins University NA COMPLETED
(Aug 1, 2026)
PHASE3
Single Dose Azithromycin to Prevent Cholera in Children Massachusetts General Hospital NA COMPLETED
(Aug 1, 2026)
PHASE2
An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM Queen Mary University of London NA COMPLETED
(Aug 1, 2026)
PHASE3
Azithromycin for Critical Asthma - Pediatrics Johns Hopkins All Children's Hospital NA RECRUITING
(Aug 1, 2026)
PHASE2, PHASE3
Effectiveness of Epigallocatechin-3-Gallate (Green Tea Extract) as Adjunctive Locally Delivered Nanotherapeutic in the Treatment of Stage II Periodontitis Mansoura University NA RECRUITING
(Aug 1, 2026)
PHASE1
Pre-treatment With Azithromycin to Reduce Immunogenicity to to Anti-TNF Agents in Patients With Crohn's Disease Rambam Health Care Campus NA RECRUITING
(Jul 1, 2026)
PHASE2
Repurposing Clinically Approved Drugs for Yaws With an Insight Into the Cutaneous Ulcer Disease Syndrome (Trep-AByaws) Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia NA COMPLETED
(Jul 1, 2026)
PHASE3
AUTOP 2: Screen-and-treat Strategy for Vaginal Flora Abnormalities by Molecular Biology in Pregnant Women at High Risk of Preterm Birth Assistance Publique Hopitaux De Marseille NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE3
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jun 4, 2026)
PHASE1, PHASE2
Sanitation, Water, and Instruction in Face-washing for Trachoma I/II University of California, San Francisco NA COMPLETED
(Jun 1, 2026)
PHASE3
Azithromycin for Meningococcal Carriage Emory University NA COMPLETED
(Jun 1, 2026)
PHASE2
A Study of Standard Drugs for Mycobacterium Avium Complex Johns Hopkins University NA COMPLETED
(May 1, 2026)
PHASE2
Finding the Optimal Regimen for Mycobacterium Abscessus Treatment The University of Queensland NA RECRUITING
(May 1, 2026)
PHASE2, PHASE3
Assessing the Impact of Unnecessary Antibiotic Treatment on the Development of Appropriate Adaptive Immune Responses in Malnourished Bangladeshi Infants University of Virginia NA NOT YET RECRUITING
(May 1, 2026)
PHASE1
Tocilizumab Treatment in Patients With COVID-19 Instituto Nacional de Cancerologia de Mexico NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial The George Washington University Biostatistics Center NA RECRUITING
(Apr 1, 2026)
PHASE3
Antibiotic Treatment of Recurrent Episodes of Asthma in Children Copenhagen Studies on Asthma in Childhood NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
Extracorporeal Photopheresis for Medicare Recipients of Lung Allografts Washington University School of Medicine NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE3
Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis University Hospital, Toulouse NA COMPLETED
(Mar 1, 2026)
PHASE3
Improving Care Through Azithromycin Research for Infants in Africa Barcelona Institute for Global Health NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE3
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0 University of Oklahoma NA RECRUITING
(Mar 1, 2026)
PHASE2
The Impact of Shigellosis and Recommended Treatment in Children Johns Hopkins Bloomberg School of Public Health NA RECRUITING
(Mar 1, 2026)
PHASE2


Azithromycin Generic API Manufacturers

Several generic applications have been filed for Azithromycin. The first generic version for Azithromycin was by Sandoz Inc and was approved on Nov 14, 2005. And the latest generic version is by Zhejiang Poly Pharm Co Ltd and was approved on Jul 27, 2023.

Given below is the list of companies who have filed for Azithromycin generic, along with the locations of their manufacturing plants worldwide.