LEVAQUIN Drug Patent Profile

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

Levaquin is a drug marketed by Janssen Pharms and is included in three NDAs.

The generic ingredient in LEVAQUIN is levofloxacin. There are thirty-one drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Levaquin

A generic version of LEVAQUIN was approved as levofloxacin by RISING on December 20^th, 2010.

Summary for LEVAQUIN

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	24
Patent Applications:	5,337
Drug Prices:	Drug price information for LEVAQUIN
What excipients (inactive ingredients) are in LEVAQUIN?	LEVAQUIN excipients list
DailyMed Link:	LEVAQUIN at DailyMed

See drug prices for LEVAQUIN

See drug sales revenues for LEVAQUIN

Recent Clinical Trials for LEVAQUIN

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

Sponsor	Phase
Indonesia University	Phase 1/Phase 2
Pfizer	Phase 2
National Lung Hospital, Vietnam	Phase 2

See all LEVAQUIN clinical trials

Paragraph IV (Patent) Challenges for LEVAQUIN

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 LEVAQUIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	LEVAQUIN	levofloxacin	INJECTABLE;INJECTION	020635-001	Dec 20, 1996		DISCN	Yes	No
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-002	Dec 20, 1996		DISCN	Yes	No
Janssen Pharms	LEVAQUIN	levofloxacin	TABLET;ORAL	020634-001	Dec 20, 1996		DISCN	Yes	No
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-003	Dec 20, 1996		DISCN	Yes	No
Janssen Pharms	LEVAQUIN	levofloxacin	INJECTABLE;INJECTION	020635-004	Dec 20, 1996		DISCN	Yes	No
Janssen Pharms	LEVAQUIN	levofloxacin	SOLUTION;ORAL	021721-001	Oct 21, 2004		DISCN	Yes	No

Expired US Patents for LEVAQUIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	LEVAQUIN	levofloxacin	TABLET;ORAL	020634-003	Sep 8, 2000	5,053,407*PED
Janssen Pharms	LEVAQUIN	levofloxacin	SOLUTION;ORAL	021721-001	Oct 21, 2004	6,806,256*PED
Janssen Pharms	LEVAQUIN	levofloxacin	TABLET;ORAL	020634-002	Dec 20, 1996	5,053,407*PED
Janssen Pharms	LEVAQUIN	levofloxacin	INJECTABLE;INJECTION	020635-001	Dec 20, 1996	4,382,892
Janssen Pharms	LEVAQUIN	levofloxacin	TABLET;ORAL	020634-001	Dec 20, 1996	5,053,407*PED
Janssen Pharms	LEVAQUIN	levofloxacin	TABLET;ORAL	020634-001	Dec 20, 1996	4,382,892

EU/EMA Drug Approvals for LEVAQUIN

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

International Patents for LEVAQUIN

See the table below for patents covering LEVAQUIN around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	8301977
Yugoslavia	45524
Norway	883791
Ireland	930628
Hong Kong	91793	OPTICALLY ACTIVE PYRIDOBENZOXAZINE DERIVATIVES
Yugoslavia	44918

Supplementary Protection Certificates for LEVAQUIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0206283	SPC/GB97/085	United Kingdom		PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606
0206283	98C0041	Belgium		PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606
0206283	C980016	Netherlands		PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606

LEVAQUIN Market Analysis and Financial Projection Experimental

Levofloxacin (Levaquin) Market Dynamics and Financial Trajectory

Introduction to Levofloxacin (Levaquin)

Levofloxacin, commonly known by its brand name Levaquin, is a potent antibiotic used to treat a variety of bacterial infections, including pneumonia, urinary tract infections, and skin infections. The market for levofloxacin is complex and influenced by several key factors.

Market Size and Growth Projections

The global levofloxacin market is anticipated to experience significant growth over the coming years. According to market forecasts, the levofloxacin market is expected to register a compounded annual growth rate (CAGR) of 5.1% to 5.3% from 2024 to 2028[3][4][5].

Current Market Valuation

As of 2023, the levofloxacin market was valued at approximately $1.67 billion. This valuation is projected to increase to $1.77 billion in the subsequent year and reach $2.17 billion by 2028[1].

Market Drivers

Several factors are driving the growth of the levofloxacin market:

Aging Population

The increasing geriatric population is a significant driver, as older individuals are more susceptible to infections that require antibiotic treatment[1][3][4].

Rise in Bacterial Infections

The growing incidence of respiratory and urinary tract infections, as well as other bacterial infections, is another key driver. Conditions such as pneumonia and tuberculosis contribute substantially to the demand for levofloxacin[1][3][4].

Antibiotic Resistance

The global challenge posed by antibiotic resistance continues to drive the need for effective antibiotics like levofloxacin, as healthcare providers seek to combat resistant bacterial strains[1].

Impact of COVID-19

The COVID-19 pandemic had a dual impact on the levofloxacin market. Initially, the demand for levofloxacin decreased due to reduced hospital visits and the prioritization of COVID-19 treatments. However, as the pandemic progressed, there was a surge in the use of antibiotics, including levofloxacin, to manage secondary infections associated with COVID-19. This surge contributed to market growth[3][4].

Regional Analysis

North America

North America holds the largest share of the levofloxacin market, supported by the presence of major market players, high incidence of chronic and infectious diseases, and technological advancements. The United States is expected to maintain a significant share within this region[3][4].

Asia-Pacific

The Asia-Pacific region is the fastest-growing market for levofloxacin, driven by increasing healthcare needs, growing populations, and improving healthcare infrastructure[3][4].

Market Segmentation

The levofloxacin market is segmented based on various factors, including:

Dosage Forms

The market includes various dosage forms such as 250 mg, 500 mg, and 750 mg tablets, as well as other formulations[1].

Distribution Channels

Levofloxacin is distributed through hospital pharmacies, retail pharmacies, and the increasingly popular online pharmacies[1].

Competitive Landscape

The levofloxacin market is characterized by a consolidated environment with key players such as:

• Lupin Limited
• Glenmark Pharmaceuticals
• Dr. Reddy's Laboratories
• Zydus Cadila
• Pax Healthcare[3][4][5]

These companies are actively engaged in product development, mergers, and geographical expansion. Strategic collaborations and acquisitions, such as Innoviva Inc.'s acquisition of Entasis Therapeutics Holdings Inc., are common in this market, indicating a relentless pursuit of innovation and new therapies[1].

Financial Trajectory

Capital and Operational Expenditures

For companies setting up levofloxacin manufacturing plants, the financial trajectory involves significant capital expenditures (CapEx) and operational expenditures (OpEx). Detailed analyses of project economics, including income projections, taxation, depreciation, liquidity analysis, and profitability analysis, are crucial for understanding the financial viability of such ventures[2].

Profitability Analysis

The profitability of levofloxacin manufacturing is influenced by factors such as gross profit margins, net profit, and market share. Companies in this sector must conduct thorough profitability analyses, including payback period, net present value (NPV), and internal rate of return (IRR) to ensure sustainable operations[2].

Market Trends and Analysis

The market is driven by emerging therapy trends and strategic collaborations. Recent developments, such as the launch of new therapies and partnerships, underscore the dynamic nature of the market. Market trends also include the increasing use of online pharmacies and the growing importance of affordability and ease of access to the drug[1][3][4].

Regulatory Landscape

Setting up a levofloxacin manufacturing plant involves navigating a complex regulatory landscape. This includes obtaining necessary certifications, complying with regulatory procedures, and securing financial assistance. A comprehensive understanding of these regulatory requirements is essential for market entry and sustainability[2].

Strategic Recommendations

For companies looking to enter or expand in the levofloxacin market, strategic recommendations include:

• Product Development: Focus on developing new formulations and targeted therapies to address emerging bacterial infections.
• Geographical Expansion: Expand operations into growing regions like Asia-Pacific to capitalize on increasing healthcare needs.
• Strategic Collaborations: Engage in mergers, acquisitions, and partnerships to drive innovation and market presence.
• Regulatory Compliance: Ensure thorough compliance with regulatory requirements to avoid legal and financial repercussions[1][3][4].

Case Study of Successful Ventures

Companies like Lupin Limited and Dr. Reddy's Laboratories have successfully navigated the levofloxacin market through strategic product development, geographical expansion, and innovative marketing strategies. These case studies provide valuable insights into the best practices for succeeding in this market[1][3].

"Levofloxacin is poised for growth over the forecast period, driven by an increasing burden of bacterial infections and the rising prevalence of diseases such as tuberculosis and pneumonia."[3]

Key Takeaways

• The levofloxacin market is expected to grow at a CAGR of 5.1% to 5.3% from 2024 to 2028.
• Key drivers include the aging population, rise in bacterial infections, and the challenge of antibiotic resistance.
• North America holds the largest market share, while the Asia-Pacific region is the fastest-growing.
• The market is characterized by a consolidated environment with major players engaging in product development and strategic collaborations.
• Regulatory compliance and financial analysis are crucial for setting up and sustaining levofloxacin manufacturing operations.

FAQs

What is the projected CAGR for the levofloxacin market from 2024 to 2028?

The levofloxacin market is expected to register a CAGR of 5.1% to 5.3% from 2024 to 2028[1][3][4].

Which region holds the largest share of the levofloxacin market?

North America holds the largest share of the levofloxacin market, supported by the presence of major market players and a high incidence of chronic and infectious diseases[3][4].

What are the key drivers of the levofloxacin market?

Key drivers include the increasing geriatric population, the rise in bacterial infections, and the global challenge posed by antibiotic resistance[1][3][4].

How did the COVID-19 pandemic impact the levofloxacin market?

The COVID-19 pandemic initially led to a decrease in demand due to reduced hospital visits, but later phases saw a surge in antibiotic use, including levofloxacin, contributing to market growth[3][4].

Who are the major players in the levofloxacin market?

Major players include Lupin Limited, Glenmark Pharmaceuticals, Dr. Reddy's Laboratories, Zydus Cadila, and Pax Healthcare[3][4][5].

Sources

1. GlobeNewswire: Levofloxacin Market Forecast Reveals Rapid Growth in Asia-Pacific Region and Advancements in Targeted Therapies.
2. IMARC Group: Levofloxacin (Levaquin) Manufacturing Plant Project Report 2024.
3. Mordor Intelligence: Global Levofloxacin Market Size - Mordor Intelligence.
4. Mordor Intelligence: Levofloxacin Market Size & Share Analysis - Mordor Intelligence.
5. Cognitive Market Research: Levofloxacin Market Report 2024 (Global Edition).