AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Avelox In Sodium Chloride 0.8% In Plastic Container, and what generic alternatives are available?

Avelox In Sodium Chloride 0.8% In Plastic Container is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Avelox In Sodium Chloride 0.8% In Plastic Container

A generic version of AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER was approved as moxifloxacin hydrochloride by TEVA PHARMS USA on February 18^th, 2014.

Summary for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	82
DailyMed Link:	AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

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

Sponsor	Phase
Daiichi Sankyo, Inc.	Phase 4
Usona Institute	Phase 1
SAMI Pharmaceutical, Karachi Pakistan	Phase 1

See all AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for AVELOX IN SODIUM CHLORIDE 0.8% 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
Bayer Hlthcare	AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	moxifloxacin hydrochloride	SOLUTION;INTRAVENOUS	021277-001	Nov 30, 2001		DISCN	Yes	No

Expired US Patents for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	moxifloxacin hydrochloride	SOLUTION;INTRAVENOUS	021277-001	Nov 30, 2001	4,990,517
Bayer Hlthcare	AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	moxifloxacin hydrochloride	SOLUTION;INTRAVENOUS	021277-001	Nov 30, 2001	6,548,079
Bayer Hlthcare	AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	moxifloxacin hydrochloride	SOLUTION;INTRAVENOUS	021277-001	Nov 30, 2001	5,849,752
Bayer Hlthcare	AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	moxifloxacin hydrochloride	SOLUTION;INTRAVENOUS	021277-001	Nov 30, 2001	5,607,942

International Patents for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

See the table below for patents covering AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Ireland	892293
Honduras	2000000115	FORMULACION DE SAL COMUN Y MOXIFLOXACINA
Canada	2378424	COMPOSITION DE SEL DE CUISINE A BASE DE MOXIFLOXACINE (MOXIFLOXACIN FORMULATION CONTAINING COMMON SALT)
Australia	6055694
Germany	19975060

Supplementary Protection Certificates for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0780390	PA2004012,C0780390	Lithuania		PRODUCT NAME: MOXIFLOXACINI HYDROCHLORIDUM (1-CIKLOPROPIL-6-FLUOR-1,4-DIHIDRO-8-METOKSI-7-((4AS, 7AS)-OKTAHIDRO-6H-PIROLO(3,4-B)PIRIDIN-6-IL)-4-OKSO-3-CHINOLINKARBOKSIRUGSTIES HIDROCHLORIDAS); REGISTRATION NO/DATE: 04/8383/3 20040309
0350733	SPC/GB03/034	United Kingdom		PRODUCT NAME: MOXIFLOXACIN AND PHARMACEUTICALLY USABLE HYDRATES AND ACID ADDITION SALTS THEREOF AND THE ALKALI METAL, ALKALINE EARTH METAL, SILVER AND GUANIDINIUM SALTS OF THE UNDERLYING CARBOXYLIC ACIDS AND THE RACEMATES THEREOF; REGISTERED: DE 45263.00.00 19990621; UK PL 000 10/0291 20030313
0350733	2001C/030	Belgium		PRODUCT NAME: MOXIFLOXACINE CHLORHYDRATE (CORRESPONDANT A MOXIFLOXACINE); NATL. REGISTRATION NO/DATE: 187 IS 328 F 3 20010507; FIRST REGISTRATION: DE 45263.00.00 19990621
0350733	300111	Netherlands
0350733	11/2000	Austria		PRODUCT NAME: MOXIFLOXACIN, DESSEN PHARMAZEUTISCH VERWENDBARE HYDRATE UND SAEUREADDITIONSSALZE, DESSEN ALKALI-ERDALKALI-SILBER- UND GUANIDINIUMSALZE, SOWIE DESSEN C1 - C4 ALKYL- ODER; NAT. REGISTRATION NO/DATE: 1-23494, 1-23495, 1-23496 20000215; FIRST REGISTRATION: DE 45263.00.00 19990621

Market Dynamics and Financial Trajectory for AVELOX in Sodium Chloride 0.8% in Plastic Container

Last updated: July 28, 2025

Introduction

Avelox (moxifloxacin) in Sodium Chloride 0.8% in plastic container represents a notable formulation in the antimicrobial segment, primarily indicated for intravenous administration. The combination of a broad-spectrum fluoroquinolone antibiotic with a saline infusion medium addresses critical needs in inpatient settings, especially for severe bacterial infections. Analyzing its market dynamics and financial trajectory necessitates understanding its clinical positioning, manufacturing landscape, competitive environment, regulatory influences, and potential growth drivers.

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Product Profile and Clinical Utility

Avelox, under its IV formulation in Sodium Chloride 0.8%, is designed to facilitate hospital-based antimicrobial therapy. It offers a convenient infusion option with compatibility in standard saline solutions, simplifying intravenous therapy protocols. The formulation's stability, pharmacokinetics, and efficacy profile influence its acceptance among healthcare providers, especially in acute care settings.

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Market Demand Drivers

1. Rising Prevalence of Severe Bacterial Infections
The global increase in conditions such as pneumonia, complicated intra-abdominal infections, and skin infections fuels demand for potent antibiotics. Hospitals prioritize broad-spectrum agents like moxifloxacin for empiric therapy, especially amidst rising antimicrobial resistance.

2. Hospital and ICU Market Dynamics
Intravenous antibiotics are critical in inpatient care. The shift towards outpatient parenteral antimicrobial therapy (OPAT) is limited by the need for hospital administration of drugs such as Avelox IV, sustaining demand within inpatient settings.

3. Perspectives on Antibiotic Stewardship
While stewardship programs aim to curb unnecessary antibiotic use, the clinical necessity of broad-spectrum agents ensures continued demand for appropriate formulations like Avelox in saline containers.

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Regulatory and Reimbursement Environment

1. Approval Status
Regulatory agencies such as the FDA, EMA, and others have approved Avelox IV formulations, with labeling updates emphasizing safety, efficacy, and compatibility with standard saline solutions (2). Consistent regulatory clearance in major markets underpins market confidence.

2. Reimbursement Trends
Insurance coverage and hospital procurement policies favor readily available IV antibiotics with proven efficacy. Reimbursement rates directly impact the financial viability for manufacturers, especially in managed care environments.

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Manufacturing and Supply Chain Considerations

1. Production Costs
Manufacturing saline-compatible IV formulations requires specialized sterile processing, quality control, and stability testing, affecting costs. The use of plastic containers, specifically high-grade, biocompatible plastics, further influences manufacturing expenses.

2. Supply Chain Resilience
Global supply chain disruptions, notably during pandemics, have impacted raw material procurement and distribution logistics, potentially constraining availability and affecting revenue streams.

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Competitive Landscape

1. Strategic Competitors
Other fluoroquinolones such as levofloxacin and ciprofloxacin also offer IV formulations in saline. Newer agents with improved safety profiles or enhanced spectrum, including linezolid and tigecycline, further intensify the competitive pressure.

2. Differentiation Factors
Despite the competition, Avelox's broad-spectrum activity, established clinical efficacy, and compatibility with standard infusion media sustain its position. Continuous clinical research and real-world evidence bolster its market appeal.

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Market Trends and Future Growth Potential

1. Emerging Markets
Growth in emerging economies, driven by expanding healthcare infrastructure and infectious disease burden, presents substantial opportunity. Regulatory approvals in these regions expand the drug's reach.

2. Innovation and Formulation Enhancements
Development of ready-to-infuse, preservative-free formulations, or combination therapies, could extend product lifecycle and increase profitability.

3. Impact of Antimicrobial Resistance (AMR)
AMR trends necessitate judicious antibiotic use. Avelox's role may diminish if resistance patterns diminish efficacy; however, ongoing stewardship and new indications could offset this.

4. Digital Health & Precision Medicine
Integrating pharmacogenomics and personalized dosing strategies may enhance therapeutic outcomes, reinforcing the drug’s value in targeted therapies.

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Financial Trajectory Analysis

1. Revenue Streams and Profitability
Avelox IV in sodium chloride 0.8% contributes to the antiviral/antimicrobial segment’s top line, with revenue influenced by global infection rates, hospital admissions, and healthcare reimbursement policies (3). Historically, mature formulations face margin pressures due to generic competition, but branded versions maintain premium pricing driven by clinical superiority.

2. Investment in R&D and Life Cycle Management
Ongoing R&D investments, including new indications or improved delivery systems, support sustained market relevance. Licensing agreements and partnerships can also amplify revenue streams.

3. Market Penetration Strategies
Targeted marketing within hospital formularies, clinician education programs, and inclusion in clinical guidelines boost adoption rates, influencing the product's revenue trajectory positively.

4. Pricing Trends
Pricing strategies are influenced by competition, generic entry, and reimbursement policies. Premium pricing remains viable where the formulation provides clinically proven benefits.

5. Financial Risks
Key risks include regulatory challenges, shifts in antimicrobial stewardship policies, and the advent of novel therapies. Supply chain disruptions could also impair financial performance temporarily.

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Regulatory and Policy Impact on Market Dynamics

Regulations requiring rigorous clinical evidence for IV antibacterial agents influence market entry and post-market surveillance costs. Evolving policies on antimicrobial stewardship may impose prescribing restrictions, affecting sales volume but potentially improving market sustainability through enhanced clinical value prioritization.

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Conclusion

The market for Avelox in Sodium Chloride 0.8% in plastic containers is characterized by steady demand driven by serious bacterial infection treatment needs and hospital prescription habits. While facing significant competition and regulatory pressures, its well-established clinical profile and compatibility with standard saline infusions sustain its position. The financial trajectory will depend on factors like market expansion, product differentiation, manufacturing efficiencies, and evolving healthcare policies.

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Key Takeaways

• Steady Hospital Demand: The inpatient setting remains the primary market driver due to the necessity for intravenous broad-spectrum antibiotics.
• Competitive Environment: Sustained competition from other fluoroquinolones and emerging antimicrobial agents requires ongoing differentiation and clinical evidence.
• Regulatory and Reimbursement Influences: Market stability hinges on regulatory approvals, safety profiles, and reimbursement policies favoring hospital-based IV therapies.
• Supply Chain and Manufacturing: Efficient, resilient manufacturing processes are critical to maintaining supply and controlling costs.
• Future Growth Factors: Expansion into emerging markets, formulation innovations, and integration of personalized medicine strategies will shape future financial performance.

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FAQs

1. What factors influence the market share of Avelox in saline containers?
Market share is primarily driven by clinical efficacy, hospital formulary acceptance, competition from alternative antibiotics, and regulatory approvals, alongside reimbursement policies that favor certain formulations and treatment protocols.

2. How does antimicrobial resistance impact Avelox's market trajectory?
Rising resistance could reduce Avelox’s efficacy, limiting clinical usage. Conversely, ongoing stewardship and indication expansion mitigate this risk by emphasizing appropriate use and exploring new therapeutic areas.

3. Are there emerging markets where Avelox has growth potential?
Yes, regions such as Asia-Pacific, Latin America, and parts of Africa, with expanding healthcare infrastructure and increasing infectious disease burden, offer significant growth opportunities pending regulatory approvals.

4. What role does formulation innovation play in the product’s future?
Developing preservative-free, ready-to-infuse formulations or combination therapies can improve patient convenience, safety, and microbial coverage, reinforcing its market positioning and opening new revenue streams.

5. How might regulatory changes affect the financial outlook for Avelox in sodium chloride solutions?
Tighter regulations requiring extensive clinical data or stewardship-based prescribing restrictions may initially limit sales volume but ultimately support premium positioning due to sustained clinical efficacy and safety assurances.

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Sources

1. FDA Labeling for Avelox IV
2. EMA Summary of Product Characteristics for Avelox
3. Market analysis reports from IQVIA and GlobalData, 2022-2023.