LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Levofloxacin In Dextrose 5% In Plastic Container, and when can generic versions of Levofloxacin In Dextrose 5% In Plastic Container launch?

Levofloxacin In Dextrose 5% In Plastic Container is a drug marketed by Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Inforlife, and Knack. and is included in eight NDAs.

The generic ingredient in LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER 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 Levofloxacin In Dextrose 5% In Plastic Container

A generic version of LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER was approved as levofloxacin by RISING on December 20^th, 2010.

Summary for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	8
Clinical Trials:	282
DailyMed Link:	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

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 IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare Corp	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	091397-001	Aug 8, 2013		DISCN	No	No
Hospira	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	078579-003	Sep 3, 2015	AP	RX	No	No
Knack	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	216164-003	Jan 29, 2024		DISCN	No	No
Fresenius Kabi Usa	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	200674-001	Jun 19, 2013	AP	RX	No	No
Eugia Pharma	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	206919-001	Feb 10, 2016		DISCN	No	No
Gland Pharma Ltd	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	206908-003	Dec 30, 2020	AP	RX	No	No
Inforlife	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	090343-002	Jul 7, 2011	AP	RX	No	Yes

EU/EMA Drug Approvals for LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

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

Market Dynamics and Financial Trajectory for Levofloxacin in Dextrose 5% in Plastic Container

Market Overview

Levofloxacin, a broad-spectrum antibiotic, is widely used in the treatment of various bacterial infections, including pneumonia, skin infections, kidney infections, and urinary tract infections. The market for levofloxacin, particularly in the form of a 5% dextrose solution in plastic containers, is experiencing significant growth driven by several key factors.

Market Size and Growth

The global levofloxacin market is projected to grow substantially in the coming years. As of 2024, the market size is estimated to be around $1.77 billion, with a forecasted growth to $2.17 billion by 2033, at a Compound Annual Growth Rate (CAGR) of 5.3%[1][5].

Segmentation

By Type

The levofloxacin market is segmented by type into 250 mg tablets, 500 mg tablets, and 750 mg tablets. Additionally, the intravenous solution form, such as levofloxacin in 5% dextrose, is a crucial segment, especially for severe infections requiring immediate antibiotic action[1].

By Distribution Channel

The distribution channels for levofloxacin include hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are a significant segment due to the frequent use of levofloxacin in hospital settings for treating severe infections[1].

By Application

Levofloxacin is used to treat a variety of infections, including pneumonia, skin infections, kidney infections, bladder infections, and other applications. The rising incidence of these infections is a major driver for the market growth[1].

Market Drivers

Growing Incidences of Bacterial Infections

The increasing number of bacterial infections, particularly respiratory tract infections and urinary tract infections, is a primary driver for the levofloxacin market. The emergence of multidrug-resistant strains further amplifies the demand for effective antibiotics like levofloxacin[1][4].

Aging Population and Global Health Preparedness

The aging population and the increasing need for global health preparedness against infectious diseases are also significant drivers. As the population ages, the susceptibility to infections increases, leading to higher demand for antibiotics[1].

Adoption in Urinary Tract Infections (UTIs) Treatment

The adoption of levofloxacin in treating urinary tract infections is another trend that is expected to drive market growth. UTIs are common and often require effective antibiotic treatment, making levofloxacin a preferred choice[1].

Exploration of Combination Therapies

The exploration of combination therapies involving levofloxacin is gaining traction. For instance, the launch of Ducressa, a fixed-dose combination of levofloxacin and dexamethasone eye drops, highlights the innovative approaches in the market[1].

Challenges and Shortages

Despite the growth, the levofloxacin market faces challenges such as drug shortages. For example, Pfizer has levofloxacin premixed bags on back order, with estimated release dates extending into 2027. Similar shortages are reported by other manufacturers like Hikma and Sagent, primarily due to manufacturing delays and inventory depletion[2].

Regional Analysis

Asia-Pacific

The Asia-Pacific region is expected to record the fastest growth rate during the forecast period. This is attributed to the expansion of manufacturing pharmacies and increasing government initiatives to improve awareness about the diagnosis and treatment of infections[1][4].

North America

North America accounts for a significant share of the levofloxacin market, driven by high healthcare spending and a well-established pharmaceutical industry. The region is projected to maintain its position over the forecast period[4].

Competitive Landscape

The levofloxacin market is competitive, with several major companies involved. These include Janssen Pharmaceuticals, Santen Pharmaceutical, Pfizer, Hikma, and Sagent, among others. These companies are focused on innovating new products and improving their market position through advanced and targeted therapies[1][5].

Recent Developments and Clinical Trials

Recent clinical trials, such as those conducted by Beijing Chest Hospital and the National Medical Center for Infectious Diseases, are ongoing to further establish the efficacy and safety profile of levofloxacin. These trials are crucial for potential brand extensions and new market entrants[5].

Financial Trajectory

The financial trajectory of the levofloxacin market is positive, with a steady growth rate anticipated over the next decade. Here are some key financial highlights:

• Market Size in 2024: $1.77 billion[1].
• Forecasted Market Size in 2033: $2.17 billion[1].
• CAGR from 2024 to 2033: 5.3%[1].

The growth is driven by increasing demand, innovative product launches, and expanding distribution channels.

Key Takeaways

• The levofloxacin market is expected to grow significantly, driven by the increasing incidence of bacterial infections and the aging population.
• The Asia-Pacific region is anticipated to record the highest growth rate.
• Drug shortages, particularly for intravenous solutions, are a current challenge but are expected to be resolved with new product releases.
• Major companies are innovating new products and combination therapies to sustain their market position.
• Government initiatives and global health preparedness are also driving market growth.

FAQs

What is the current market size of the levofloxacin market?

The current market size of the levofloxacin market is estimated to be around $1.77 billion as of 2024[1].

What is the forecasted growth rate of the levofloxacin market?

The levofloxacin market is expected to grow at a CAGR of 5.3% from 2024 to 2033[1].

What are the main drivers of the levofloxacin market?

The main drivers include the growing incidence of bacterial infections, the aging population, and increasing global health preparedness against infectious diseases[1][4].

Which region is expected to record the fastest growth rate in the levofloxacin market?

The Asia-Pacific region is expected to record the fastest growth rate during the forecast period[1][4].

What are some of the challenges facing the levofloxacin market?

Current challenges include drug shortages due to manufacturing delays and inventory depletion[2].

Sources

1. The Business Research Company, "Global Levofloxacin Market Report 2024".
2. American Society of Health-System Pharmacists, "Drug Shortage Detail: Levofloxacin Injection in 5% Dextrose".
3. PharmaCompass, "LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER".
4. IndustryARC, "Levofloxacin Market Share, Size and Industry Growth Analysis 2020".
5. Drug Patent Watch, "Generic LEVOFLOXACIN INN entry, drug patent and freedom to operate".