Levofloxacin - Generic Drug Details

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

Levofloxacin is the generic ingredient in six branded drugs marketed by Janssen Pharms, Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Gland Pharma Ltd, Hospira, Norvium Bioscience, Rising, Zydus Pharms, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, Knack, Santen, Micro Labs Ltd India, Rubicon, Sciegen Pharms Inc, Watson Labs Teva, Lannett Co Inc, Novitium Pharma, Anda Repository, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Molecular, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Hec Pharm, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Natco Pharma, Orbion Pharms, Sandoz, Teva, Torrent Pharms, Watson Labs Inc, and Zydus Lifesciences, and is included in forty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-one drug master file entries for levofloxacin. Forty-six suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for levofloxacin

US Patents:	0
Tradenames:	6
Applicants:	38
NDAs:	48
Drug Master File Entries:	31
Finished Product Suppliers / Packagers:	46
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	282
Patent Applications:	7,712
Drug Prices:	Drug price trends for levofloxacin
Drug Sales Revenues:	Drug sales revenues for levofloxacin
What excipients (inactive ingredients) are in levofloxacin?	levofloxacin excipients list
DailyMed Link:	levofloxacin at DailyMed

See drug prices for levofloxacin

See drug sales revenues for levofloxacin

Recent Clinical Trials for levofloxacin

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

Sponsor	Phase
National Medical Center for Infectious Diseases	Phase 3
Beijing Chest Hospital	Phase 3
Elisabeth-TweeSteden Ziekenhuis	Phase 4

See all levofloxacin clinical trials

Generic filers with tentative approvals for LEVOFLOXACIN

Applicant	Application No.	Strength	Dosage Form
		5MG/ML	INJECTABLE; INJECTION
		750MG	TABLET; ORAL
		500MG	TABLET; ORAL

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

Medical Subject Heading (MeSH) Categories for levofloxacin

Anti-Bacterial Agents

Anti-Infective Agents, Urinary

Cytochrome P-450 CYP1A2 Inhibitors

Topoisomerase II Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for levofloxacin

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for LEVOFLOXACIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LEVAQUIN	Oral Solution	levofloxacin	25 mg/mL	021721	1	2009-07-30

US Patents and Regulatory Information for levofloxacin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	LEVOFLOXACIN	levofloxacin	INJECTABLE;INJECTION	200560-001	Jun 20, 2011		DISCN	No	No
Teva	LEVOFLOXACIN	levofloxacin	TABLET;ORAL	076361-003	Jun 20, 2011	AB	RX	No	No
Natco Pharma	LEVOFLOXACIN	levofloxacin	TABLET;ORAL	076276-001	Jun 20, 2011		DISCN	No	No
Dr Reddys Labs Inc	LEVOFLOXACIN	levofloxacin	TABLET;ORAL	076710-001	Jun 20, 2011	AB	RX	No	No
Aurobindo Pharma Ltd	LEVOFLOXACIN	levofloxacin	TABLET;ORAL	201043-001	Jun 20, 2011	AB	RX	No	No

Expired US Patents for levofloxacin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000	4,382,892
Janssen Pharms	LEVAQUIN	levofloxacin	TABLET;ORAL	020634-001	Dec 20, 1996	5,053,407*PED
Janssen Pharms	LEVAQUIN	levofloxacin	SOLUTION;ORAL	021721-001	Oct 21, 2004	5,053,407*PED
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-002	Dec 20, 1996	5,053,407*PED
Santen	IQUIX	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021571-001	Mar 1, 2004	5,053,407

EU/EMA Drug Approvals for levofloxacin

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Chiesi Farmaceutici S.p.A	Quinsair	levofloxacin	EMEA/H/C/002789 Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2015-03-25

Levofloxacin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Levofloxacin

Introduction to Levofloxacin

Levofloxacin, marketed under the brand name Levaquin, is a fluoroquinolone antibiotic used to treat a variety of bacterial infections, including pneumonia, urinary tract infections, and sinusitis. It works by inhibiting bacterial topoisomerase IV and DNA gyrase, essential enzymes for bacterial DNA replication and transcription[4].

Global Market Size and Growth

The levofloxacin market is projected to experience significant growth over the coming years. According to market forecasts, the global levofloxacin market is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.1% to 5.3% from 2023 to 2028. This growth is anticipated to increase the market valuation from approximately $1.67 billion in 2023 to around $2.17 billion by 2028[1][3].

Market Drivers

Several factors are driving the growth of the levofloxacin market:

Increasing Prevalence of Bacterial Infections

The rising incidence of bacterial diseases such as pneumonia, tuberculosis, and urinary tract infections is a key driver. For instance, the World Health Organization (WHO) reports that tuberculosis cases are prevalent in regions like South-East Asia, Africa, and the Western Pacific, which is expected to drive the demand for levofloxacin[1].

Aging Population

The growing geriatric demographic is another significant factor. Older populations are more susceptible to infections, leading to an increased demand for antibiotics like levofloxacin[3].

Antibiotic Resistance

The ongoing challenge of antibiotic resistance globally also contributes to the market growth, as there is a continuous need for effective antibiotics like levofloxacin[3].

Regional Analysis

North America

North America currently holds the largest market share due to the presence of major market players and a high incidence of chronic and infectious diseases such as pneumonia and urinary tract infections. Government initiatives aimed at improving diagnosis and treatment of these conditions also support market growth in this region[1][4].

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing market, driven by the expansion of manufacturing pharmacies and increasing awareness about bacterial infections. This region is particularly significant due to its large population and the high burden of diseases like pneumonia and tuberculosis[1][4].

Market Segmentation

The levofloxacin market is segmented based on dosage forms, including 250 mg, 500 mg, and 750 mg tablets, and distribution channels such as hospital and retail pharmacies, as well as online pharmacies. The market also covers various conditions treated with levofloxacin, including pneumonia, acute bacterial sinusitis, chronic prostatitis, and urinary tract infections[3].

Cost-Effectiveness and Economic Impact

Studies have shown that oral levofloxacin is as effective as sequential antibiotic treatment for community-acquired pneumonia (CAP) but does not necessarily lead to significant cost savings for the healthcare system. However, it does reduce drug acquisition costs and nurses' work time with drug administration. The total hospital and rehabilitation costs can be lower in the levofloxacin group, especially when excluding outliers with extended hospital stays[2][5].

Competitive Landscape

The levofloxacin market is highly competitive, with major players such as Zydus Cadila, Dr. Reddy's Laboratories Ltd., LUPIN LIMITED, PAX HEALTHCARE, and Allenge India Pharma. These companies are involved in strategic collaborations and mergers to drive innovation and introduce new therapies, further energizing the market[1][3].

Strategic Collaborations and Innovations

The market is witnessing significant corporate activities, such as Innoviva Inc.'s acquisition of Entasis Therapeutics Holdings Inc., which highlights the industry's pursuit of innovation. These strategic moves are expected to shape market dynamics and introduce new targeted therapies, contributing to the market's growth[3].

Challenges and Limitations

Despite the growth prospects, the market faces challenges such as limited public awareness about infectious diseases and the potential side effects associated with fluoroquinolone antibiotics. These factors can slow down market growth and necessitate ongoing educational and awareness campaigns[1].

Key Takeaways

• The levofloxacin market is expected to grow at a CAGR of 5.1% to 5.3% from 2023 to 2028.
• The market is driven by the increasing prevalence of bacterial infections, an aging population, and the challenge of antibiotic resistance.
• North America holds the largest market share, while the Asia-Pacific region is the fastest-growing.
• Oral levofloxacin is cost-effective in terms of drug acquisition costs but may not lead to overall cost savings for the healthcare system.
• Major players are engaged in strategic collaborations to drive innovation and market growth.

FAQs

What is the current global market size of levofloxacin?

The global levofloxacin market is projected to be around $1.67 billion in 2023 and is expected to grow to $2.17 billion by 2028[3].

Who are the major players in the global levofloxacin market?

Major players include Zydus Cadila, Dr. Reddy's Laboratories Ltd., LUPIN LIMITED, PAX HEALTHCARE, and Allenge India Pharma[1].

Which region is expected to grow the fastest in the levofloxacin market?

The Asia-Pacific region is expected to grow at the highest CAGR over the forecast period[1][4].

What are the primary drivers of the levofloxacin market?

The primary drivers include the increasing prevalence of bacterial infections, an aging population, and the challenge of antibiotic resistance[1][3].

Is oral levofloxacin cost-effective compared to other treatments?

Oral levofloxacin is cost-effective in terms of drug acquisition costs but does not necessarily lead to overall cost savings for the healthcare system[2][5].

Cited Sources:

1. Mordor Intelligence - Levofloxacin Market Size & Share Analysis
2. European Respiratory Journal - Cost-effectiveness of full-course oral levofloxacin in severe CAP
3. GlobeNewswire - Levofloxacin Market Forecast Reveals Rapid Growth in Asia-Pacific Region and Advancements in Targeted Therapies
4. IndustryARC - Levofloxacin Market Share, Size and Industry Growth Analysis 2020
5. PubMed - Cost-effectiveness of full-course oral levofloxacin in community-acquired pneumonia