Linezolid - Generic Drug Details

What are the generic drug sources for linezolid and what is the scope of patent protection?

Linezolid is the generic ingredient in three branded drugs marketed by Hetero Labs, Hikma, Pfizer, Eugia Pharma, Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms Inc, Sandoz, Teva Pharms, Alembic, Alkem Labs Ltd, Amneal Pharms, Chartwell Rx, Gate Pharms, Glenmark Speclt, Hetero Labs Ltd V, Macleods Pharms Ltd, Novel Labs Inc, Rising, Teva Pharms Usa, and Zydus Pharms, and is included in twenty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for linezolid. Twenty-five suppliers are listed for this compound.

Summary for linezolid

US Patents:	0
Tradenames:	3
Applicants:	24
NDAs:	28
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	146
Patent Applications:	5,575
Drug Prices:	Drug price trends for linezolid
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for linezolid
What excipients (inactive ingredients) are in linezolid?	linezolid excipients list
DailyMed Link:	linezolid at DailyMed

See drug prices for linezolid

Recent Clinical Trials for linezolid

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

Sponsor	Phase
Helmholtz Zentrum Munchen	Phase 2
Otsuka Pharmaceutical Development & Commercialization, Inc.	Phase 2
University of Liverpool	Phase 2

See all linezolid clinical trials

Pharmacology for linezolid

Drug Class

Oxazolidinone Antibacterial

Medical Subject Heading (MeSH) Categories for linezolid

Anti-Bacterial Agents

Protein Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for linezolid

J01XX	Other antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for LINEZOLID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZYVOX	Injection	linezolid	2 mg/mL, 100 mL bag	021131	1	2009-12-29
ZYVOX	Injection	linezolid	2 mg/mL, 300 mL bag	021131	1	2009-09-01
ZYVOX	Oral Suspension	linezolid	100 mg/5 mL	021132	1	2009-08-03
ZYVOX	Tablets	linezolid	600 mg	021130	1	2005-12-21

US Patents and Regulatory Information for linezolid

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sagent Pharms Inc	LINEZOLID	linezolid	SOLUTION;INTRAVENOUS	204696-002	Mar 2, 2017	AP	RX	No	No
Sagent Pharms Inc	LINEZOLID	linezolid	SOLUTION;INTRAVENOUS	204696-001	Mar 2, 2017	AP	RX	No	No
Eugia Pharma	LINEZOLID	linezolid	SOLUTION;INTRAVENOUS	206917-001	Aug 4, 2016	AP	RX	No	No
Pfizer	ZYVOX	linezolid	SOLUTION;INTRAVENOUS	021131-002	Apr 18, 2000		DISCN	Yes	No
Nang Kuang Pharm Co	LINEZOLID	linezolid	SOLUTION;INTRAVENOUS	207354-002	Dec 20, 2016	AP	RX	No	No
Chartwell Rx	LINEZOLID	linezolid	TABLET;ORAL	210702-001	Apr 25, 2019	AB	RX	No	No
Teva Pharms	LINEZOLID	linezolid	SOLUTION;INTRAVENOUS	200222-001	Jun 27, 2012		DISCN	No	No

Expired US Patents for linezolid

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-002	Apr 18, 2000
Pfizer	ZYVOX	linezolid	SOLUTION;INTRAVENOUS	021131-002	Apr 18, 2000
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-001	Apr 18, 2000
Pfizer	ZYVOX	linezolid	FOR SUSPENSION;ORAL	021132-001	Apr 18, 2000
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-001	Apr 18, 2000
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-002	Apr 18, 2000
Pfizer	ZYVOX	linezolid	SOLUTION;INTRAVENOUS	021131-003	Apr 18, 2000

Linezolid Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Linezolid

Introduction

Linezolid, an antibiotic effective against Gram-positive bacterial infections, including those resistant to other antibiotics, is a crucial component in the fight against antibiotic-resistant bacteria. Here, we delve into the market dynamics and financial trajectory of linezolid, highlighting key drivers, restraints, opportunities, and challenges.

Market Drivers

Increasing Incidences of Multi-Drug-Resistant Bacterial Infections

The rising prevalence of multi-drug-resistant bacterial infections is a significant driver for the linezolid market. As bacteria become increasingly resistant to traditional antibiotics, the demand for effective alternatives like linezolid surges[1][3].

Growing Elderly Population

The elderly population is more susceptible to infections, which increases the demand for linezolid. This demographic shift contributes to the market's growth as healthcare providers seek effective treatments for this vulnerable group[1][3].

Government Initiatives and Healthcare Spending

Government initiatives to combat antibiotic resistance and increased healthcare spending also drive the market. These initiatives often include programs to promote the use of effective antimicrobial therapies, which can include linezolid[1][3].

Advancements in Drug Delivery Systems

The introduction of sophisticated drug delivery systems that improve patient compliance is another key driver. These systems make linezolid more accessible and easier to administer, particularly in home care settings[1].

Market Restraints

High Costs and Adverse Reactions

Despite its efficacy, linezolid is associated with high costs compared to other antibiotics, which can be a significant barrier. Additionally, potential adverse reactions and the need for careful patient monitoring can limit its adoption[1][2].

Stringent Regulatory Environments

Stringent regulatory environments can hamper the approval and market entry of linezolid, particularly in regions with strict pharmaceutical regulations. This can slow down market expansion and limit access to this critical antibiotic[1].

Market Opportunities

Emerging Markets and Strategic Partnerships

There are significant opportunities in emerging markets where healthcare access is increasing. Strategic partnerships with healthcare providers can help expand the reach of linezolid in these regions[1][3].

Research and Development

Ongoing research into combination therapies and innovative formulations can present additional avenues for market expansion. Improving linezolid formulations and developing generic versions without compromising efficacy can enhance market competitiveness[1][3].

Feedback from Healthcare Professionals

Incorporating feedback from healthcare professionals to refine and innovate linezolid formulations is crucial. This can lead to better patient outcomes and increased adoption of the drug[1].

Market Challenges

Generic Competition

The impact of generic competition on the market dynamics of linezolid is a significant challenge. Generic versions can reduce the market share of branded linezolid, necessitating continuous innovation and strategic marketing[1].

Member Cost Share and Utilization Management

High member cost shares can result in treatment delays and hospital readmissions. Utilization management programs, such as prior authorization, can affect the economic outcomes and patient access to linezolid[2].

Financial Trajectory

Market Size and Growth

The linezolid market was valued at USD 1.2 billion in 2023 and is expected to reach USD 1.8 billion by 2031, growing at a CAGR of 5.3% from 2024 to 2031. This growth is driven by the increasing prevalence of bacterial illnesses resistant to drugs and the efficacy of linezolid against Gram-positive infections[3].

Revenue and Cost Analysis

Studies have shown that linezolid can result in higher overall success rates and be less costly than other antibiotics in certain scenarios. For instance, initiating treatment with linezolid can be less costly than vancomycin when the likelihood of a patient being infected by a resistant pathogen is high[5].

Economic Outcomes of Utilization Management

Prior authorization programs for linezolid have been shown to result in cost savings without negatively impacting medical outcomes. These programs can help manage the high costs associated with linezolid and ensure its appropriate use[2].

Geographical and Segment Analysis

Geographical Segments

The linezolid market is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Emerging markets in these regions offer significant growth opportunities due to increasing healthcare access and infrastructure[1][3].

Product Segments

Linezolid is available in various forms, including tablets, injection vials, oral suspension, and extended-release tablets. Each form has its own market dynamics, with oral suspension being particularly important for patient compliance in home care settings[1][3].

Competitive Landscape

Key Players

The market is dominated by key players such as Pfizer, Merck, Novartis, Johnson & Johnson, Teva Pharmaceuticals, Mylan, Sandoz, Aurobindo Pharma, Glenmark Pharmaceuticals, and Sun Pharmaceutical. These companies are involved in continuous R&D and strategic alliances to maintain their market share[1][3][4].

Key Takeaways

• The linezolid market is driven by increasing incidences of multi-drug-resistant bacterial infections and a growing elderly population.
• Government initiatives and advancements in drug delivery systems also contribute to market growth.
• High costs, adverse reactions, and stringent regulatory environments are significant restraints.
• Opportunities exist in emerging markets and through continuous R&D and strategic partnerships.
• The market is expected to grow at a CAGR of 5.3% from 2024 to 2031.

FAQs

1. What are the primary drivers of the linezolid market?

The primary drivers include increasing incidences of multi-drug-resistant bacterial infections, a growing elderly population, government initiatives, and advancements in drug delivery systems.

2. What are the main challenges facing the linezolid market?

High costs, potential adverse reactions, stringent regulatory environments, and generic competition are the main challenges.

3. How does linezolid compare to other antibiotics in terms of cost and efficacy?

Linezolid can result in higher overall success rates and be less costly than other antibiotics in certain scenarios, particularly when the likelihood of a patient being infected by a resistant pathogen is high.

4. What role do utilization management programs play in the linezolid market?

Utilization management programs, such as prior authorization, can help manage costs and ensure appropriate use of linezolid without negatively impacting medical outcomes.

5. Which regions offer the most significant growth opportunities for the linezolid market?

Emerging markets in regions such as Asia-Pacific, South America, and the Middle East and Africa offer significant growth opportunities due to increasing healthcare access and infrastructure.

Cited Sources:

1. 360iResearch: Linezolid for Oral Suspension Market Size & Share 2025-2030.
2. Pharmacy Times: A Linezolid Prior Authorization Program: Clinical and Economic Outcomes.
3. Market Research Intellect: Linezolid Market Size and Projections.
4. Valuates Reports: Global Linezolid Tablets Market Research Report 2024.
5. PubMed: Economic evaluation of linezolid, flucloxacillin and vancomycin in the treatment of complicated skin and skin structure infections.