Linezolid Patent Expiration

Linezolid is used for treating microbial infections. It was first introduced by Pfizer Inc in its drug Zyvox on Apr 18, 2000. Another drug containing Linezolid is Linezolid In Sodium Chloride 0.9% In Plastic Container. 25 different companies have introduced drugs containing Linezolid.


Linezolid Patents

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

Filter patents by

NEW
Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Zyvox US6514529

(Pediatric)

Oxazolidinone tablet formulation Sep 15, 2021

(Expired)

Pfizer
Zyvox US6559305

(Pediatric)

Linezolid—crystal form II Jul 29, 2021

(Expired)

Pfizer
Zyvox US6514529 Oxazolidinone tablet formulation Mar 15, 2021

(Expired)

Pfizer
Zyvox US6559305 Linezolid—crystal form II Jan 29, 2021

(Expired)

Pfizer
Zyvox US6559305 Linezolid—crystal form II Jan 29, 2021

(Expired)

Pfizer
Zyvox US5688792

(Pediatric)

Substituted oxazine and thiazine oxazolidinone antimicrobials May 18, 2015

(Expired)

Pfizer
Zyvox US5688792 Substituted oxazine and thiazine oxazolidinone antimicrobials Nov 18, 2014

(Expired)

Pfizer



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 Linezolid's patents.

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

Activity Date Patent Number
Patent litigations
Correspondence Address Change 29 Aug, 2014 US6559305(Litigated)
Correspondence Address Change 28 Aug, 2014 US6514529
Patent Issue Date Used in PTA Calculation 06 May, 2003 US6559305(Litigated)
Recordation of Patent Grant Mailed 06 May, 2003 US6559305(Litigated)
Issue Notification Mailed 17 Apr, 2003 US6559305(Litigated)
Receipt into Pubs 07 Apr, 2003 US6559305(Litigated)
Application Is Considered Ready for Issue 03 Apr, 2003 US6559305(Litigated)
Receipt into Pubs 02 Apr, 2003 US6559305(Litigated)
Receipt into Pubs 03 Mar, 2003 US6559305(Litigated)
Workflow - File Sent to Contractor 03 Mar, 2003 US6559305(Litigated)


Linezolid's Family Patents

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List



Clinical Trials

Recent Clinical Trials on Linezolid:

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
Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus Debiopharm International SA NA TERMINATED
(Sep 1, 2026)
PHASE2
Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis University of California, San Francisco NA RECRUITING
(Aug 1, 2026)
PHASE2, PHASE3
Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis Gates Medical Research Institute NA SUSPENDED
(Aug 1, 2026)
PHASE2
Alternative Antibiotics for Syphilis 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
Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis Gates Medical Research Institute NA RECRUITING
(Jul 1, 2026)
PHASE2
Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB Global Alliance for TB Drug Development NA RECRUITING
(Jul 1, 2026)
PHASE2
TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB Centers for Disease Control and Prevention NA COMPLETED
(Jun 1, 2026)
PHASE1, PHASE2
Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis GlaxoSmithKline NA COMPLETED
(May 1, 2026)
PHASE2
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis Otsuka Pharmaceutical Development & Commercialization, Inc. NA RECRUITING
(May 1, 2026)
PHASE3
Phase IIb and III Safety and Efficacy Study Chlorin E6 Gel Photodynamic Therapy for Diabetic Foot Ulcers: United Medical and Dental College NA RECRUITING
(Apr 1, 2026)
PHASE3


Linezolid Generic API Manufacturers

Several generic applications have been filed for Linezolid. The first generic version for Linezolid was by Teva Pharmaceuticals Usa and was approved on Jun 27, 2012. And the latest generic version is by Caplin Steriles Ltd and was approved on Dec 8, 2025.

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


Linezolid News

Novo's CEO is departing, while hospitals are producing medications - STAT News

16 May, 2025

See More