LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile

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

Levaquin In Dextrose 5% In Plastic Container is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in LEVAQUIN 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 Levaquin In Dextrose 5% In Plastic Container

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

Summary for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	24
DailyMed Link:	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER at DailyMed

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

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

Sponsor	Phase
Indonesia University	Phase 1/Phase 2
Otsuka Pharmaceutical Co., Ltd.	Phase 2
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2

See all LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for LEVAQUIN 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
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-002	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 IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-005	Dec 20, 1996		DISCN	Yes	No

Expired US Patents for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-002	Dec 20, 1996
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-005	Dec 20, 1996
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-002	Dec 20, 1996
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-003	Dec 20, 1996
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-003	Dec 20, 1996

EU/EMA Drug Approvals for LEVAQUIN 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

International Patents for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

See the table below for patents covering LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	63613	DIHYDROHALO OXO-PYRIDO(1,2,3-DE)(1,4)BENZOXAZINE CARBOXYLIC ACID DERIVATIVES,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Japan	H0720946
Slovenia	8811867	OPTICALLY ACTIVE DERIVATIVE OF BENZOXAZINE
Slovenia	8912098	PROCESS FOR OBTAINING A DERIVAT OF S(-) PYRIDOBENZ-OXAZIN
South Africa	8604518
Spain	505116

Supplementary Protection Certificates for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for LEVAQUIN in 5% Dextrose in Plastic Containers

Introduction

LEVAQUIN, a synthetic broad-spectrum antibacterial agent, is widely used in the treatment of various bacterial infections. When administered intravenously, it is often formulated in 5% dextrose solutions packaged in plastic containers. This article delves into the market dynamics and financial trajectory of LEVAQUIN in 5% dextrose in plastic containers, highlighting key factors influencing its market presence.

Market Demand and Usage

LEVAQUIN is a critical component in the arsenal against bacterial infections, particularly in hospital settings. The demand for intravenous formulations of LEVAQUIN is driven by its efficacy in treating severe infections where oral administration is not feasible or effective. The convenience and ready-to-use nature of premixed solutions in 5% dextrose have made these formulations popular among healthcare providers[3].

Product Availability and Manufacturers

Several pharmaceutical companies, including Pfizer, Hikma, Sagent, and WG Critical Care, manufacture and distribute LEVAQUIN in 5% dextrose intravenous solutions. These products are available in various concentrations, such as 250 mg/50 mL, 500 mg/100 mL, and 750 mg/150 mL, catering to different clinical needs[4].

Supply Chain and Shortages

The market for LEVAQUIN in 5% dextrose has faced challenges due to supply chain disruptions and manufacturing delays. For instance, Baxter has discontinued the production of levofloxacin premixed bags, and other manufacturers like Hikma and Pfizer have experienced backorders due to manufacturing delays. These shortages have impacted the availability of the drug, particularly the 750 mg/150 mL premixed bags, which are currently depleted[4].

Financial Impact of Shortages

Shortages and supply chain issues have significant financial implications for both manufacturers and healthcare providers. The inability to meet demand can lead to lost revenue for manufacturers and increased costs for healthcare providers who may need to source alternative treatments or manage inventory more tightly. For example, Pfizer estimates that the shortage of their premixed bags will continue until December 2027, which could result in substantial financial losses over the extended period[4].

Pricing and Cost Considerations

The pricing of LEVAQUIN in 5% dextrose solutions is influenced by several factors, including production costs, market demand, and competition. The cost of these solutions can vary depending on the manufacturer and the specific formulation. For instance, the National Drug Code (NDC) listings indicate different pricing tiers for products from various manufacturers, reflecting variations in production and distribution costs[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of LEVAQUIN. The FDA regulates the manufacturing, labeling, and distribution of these products, ensuring compliance with safety and efficacy standards. Any changes in regulatory requirements or guidelines can impact the production and availability of LEVAQUIN in 5% dextrose solutions[1][5].

Clinical Pharmacology and Efficacy

The clinical efficacy of LEVAQUIN is a key driver of its market demand. Levofloxacin is rapidly absorbed and excreted, with a mean terminal plasma elimination half-life of approximately 6 to 8 hours. Its broad-spectrum antibacterial activity and favorable pharmacokinetic profile make it a preferred choice for treating various infections. The stability of levofloxacin in different infusion fluids, except for a few specific diluents like 20% mannitol, further supports its widespread use[2][5].

Market Competition

The market for intravenous antibacterial agents is competitive, with several other drugs available for similar indications. However, LEVAQUIN's established reputation, broad-spectrum activity, and convenient premixed formulations contribute to its strong market position. Manufacturers continually invest in research and development to improve formulations and address any emerging resistance issues, which helps maintain market share[3].

Future Outlook

The future outlook for LEVAQUIN in 5% dextrose solutions is influenced by several factors, including the resolution of current supply chain issues, advancements in manufacturing technology, and the emergence of new bacterial resistance patterns. As manufacturers work to restore full production capacity and address backorders, the market is expected to stabilize. Additionally, ongoing research into new formulations and delivery systems could further enhance the product's market position.

Key Takeaways

• Market Demand: Driven by the need for effective intravenous antibacterial treatments.
• Supply Chain: Currently impacted by shortages and manufacturing delays.
• Financial Impact: Shortages result in lost revenue and increased costs.
• Pricing: Influenced by production costs, demand, and competition.
• Regulatory Environment: FDA regulations are crucial for compliance and market presence.
• Clinical Efficacy: Broad-spectrum activity and favorable pharmacokinetics drive demand.
• Market Competition: LEVAQUIN maintains a strong position due to its established reputation and convenient formulations.
• Future Outlook: Expected stabilization as supply chain issues are resolved and new research emerges.

FAQs

What are the common concentrations of LEVAQUIN in 5% dextrose solutions?

LEVAQUIN in 5% dextrose solutions is available in concentrations of 250 mg/50 mL, 500 mg/100 mL, and 750 mg/150 mL[3].

Why are there shortages of LEVAQUIN in 5% dextrose solutions?

Shortages are due to manufacturing delays and the discontinuation of production by some manufacturers, such as Baxter[4].

How does the regulatory environment impact LEVAQUIN in 5% dextrose solutions?

The FDA regulates the manufacturing, labeling, and distribution of these products, ensuring compliance with safety and efficacy standards[1][5].

What are the key factors influencing the pricing of LEVAQUIN in 5% dextrose solutions?

Pricing is influenced by production costs, market demand, and competition among manufacturers[4].

What is the future outlook for LEVAQUIN in 5% dextrose solutions?

The market is expected to stabilize as supply chain issues are resolved, and ongoing research into new formulations and delivery systems could further enhance the product's market position.

Sources

1. LEVAQUIN Tablets/Injection - FDA Label[1]
2. Stability of levofloxacin in intravenous solutions in polyvinyl chloride - PubMed[2]
3. Levofloxacin in 5% Dextrose Injection, USP - Pfizer Medical Information[3]
4. Drug Shortage Detail: Levofloxacin Injection in 5% Dextrose - ASHP[4]
5. LEVAQUIN Injection in Premix Flexible Containers - FDA Label[5]