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-five 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	5,849,752
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	5,607,942

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
Germany	59609501
Hungary	213099	PROCESS FOR PRODUCING 2,8-DIAZABICYCLO[4.3.0]NONAN
European Patent Office	0350733	Dérivés d'acides 7-(1-pyrrolidinyl)-3-quinolone et -naphtyridone carboxyliques, procédé pour leur préparation (7-(1-Pyrrolidinyl)-3-quinolone- and -naphthyridone-carboxylic-acid derivatives, method for their preparation and for substituted mono- and bi-cyclic pyrrolidine intermediates, and their antibacterial and feed additive compositions)
Russian Federation	2260429	СОСТАВЫ МОКСИФЛОКСАЦИНА, СОДЕРЖАЩИЕ ПОВАРЕННУЮ СОЛЬ (SODIUM CHLORIDE-CONTAINING MOXIFLOXACIN COMPOSITIONS)

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0780390	PA2004012	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-CHINOLINKARBOKSIRûGðTIES HIDROCHLORIDAS)
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	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

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER Market Analysis and Financial Projection

Last updated: February 8, 2026

What Are the Market Dynamics for Avelox in Sodium Chloride 0.8%?

Avelox (moxifloxacin) in sodium chloride 0.8% in plastic container is a formulation designed for intravenous administration. It targets hospital settings primarily for treatment of bacterial infections. The overall market involves several components:

• Regulatory Approvals: Currently approved by FDA for certain indications, including bacterial conjunctivitis and adult community-acquired pneumonia. Approval status influences market penetration.

• Competitor Landscape: Competes with other IV antibiotics such as levofloxacin, ciprofloxacin, and newer agents like delafloxacin. The prevalence of resistant bacteria influences demand for moxifloxacin-based therapies.

• Market Drivers:

  • Rising incidence of bacterial infections, especially in hospitalized and immunocompromised patients.
  • Growing preference for broad-spectrum antibiotics with once-daily dosing.
  • Expansion into emerging markets with increasing healthcare infrastructure.

• Market Limitations:

  • Stringent regulatory pathways for IV formulations.
  • Concerns over antibiotic resistance impacting prescription practices.
  • Cost and reimbursement issues in various regions.

• Impact of COVID-19: Increased focus on bacterial co-infections generated initial demand; however, overall hospital stay reductions could limit sputum infusion utilization.

How Does the Financial Trajectory Look for Avelox in this Formulation?

Financial performance depends on sales volume, pricing strategies, and market penetration:

• Sales Performance:

  • Estimated global sales for Avelox’s IV formulations were approximately $600 million in FY 2021 [1].
  • IV segment accounts for roughly 35-40% of total Avelox sales, indicating a niche but significant contribution to the revenue stream.

• Pricing Trends:

  • Average wholesale prices (AWP) in the U.S. hover around $45–$65 per 250 mg vial.
  • Price reductions are common due to biosimilar entries and generic competition in certain markets.

• Market Penetration & Usage Trends:

  • In the US, IV antibiotic use is gradually shifting towards outpatient settings, impacting volume.
  • Hospitals in Europe and Asia are expanding use, but price sensitivity affects margins.

• Forecasted Growth:

  • Projected compound annual growth rate (CAGR) for IV antibiotics including moxifloxacin is roughly 3-4% over the next five years [2].
  • Avelox’s IV sales are expected to grow modestly as new indications are explored, such as bacterial conjunctivitis, which is still early in commercial adoption.

• Patent and Generic Status:

  • Avelox’s primary patents expired in the U.S. in 2012 [3], which introduces generic competition, pressuring prices and margins.
  • Recent patents for specific formulations, including IV, may afford temporary exclusivity.

• Pipeline & Future Opportunities:

  • Limited evidence suggests marketing efforts towards combination therapies or new indications could bolster sales.
  • The increased focus on combatting antimicrobial resistance (AMR) could favor the adoption of moxifloxacin in some settings.

How Do Regulatory and Policy Factors Influence the Market?

• FDA and EMA Approvals: Confirmed indications expand the potential patient pool but may be limited for IV formulations due to administration challenges.
• Reimbursement Landscape: Coverage policies vary, affecting hospital procurement. In the U.S., Medicare and private insurers' policies determine utilization.
• Antibiotic Stewardship: Policies aimed at reducing antibiotic overuse may constrain growth, favoring narrow-spectrum agents over broad-spectrum moxifloxacin.

Summary of Business and Market Assumptions

Aspect	Status/Trend	Impact
Regulatory approvals	Approved for specific indications; expanding	Supports expansion into new indications and markets
Competitive landscape	High competition, biosimilar entry ongoing	Pressures pricing and margins
Market size and growth	Estimated $40 billion global antibiotics market with moderate growth	Limited upside with current indications
Patent status	Expired for most formulations; some exclusivity for specific formulations	Marginally supports pricing power
Pricing and reimbursement	Static or declining in some regions	Limits revenue growth

Key Takeaways

• The market for Avelox IV in sodium chloride 0.8% is shaped by its broad-spectrum activity, resistance patterns, and regulatory factors.
• Revenue prospects are modest, constrained by generic competition and shifting prescribing practices.
• Growth relies on new indications and markets, with a focus on antimicrobial stewardship policies.
• Price pressures and reimbursement policies significantly influence financial trajectory.
• The drug's future depends on its positioning within evolving antimicrobial strategies and resistance management.

FAQs

1. What are primary competitors to Avelox IV in the hospital setting?
Levofloxacin, ciprofloxacin, and newer agents like delafloxacin dominate the broad-spectrum IV antibiotic market.

2. How does antibiotic resistance impact Avelox's sales?
Resistance reduces efficacy, leading clinicians to prefer alternative therapies, which can limit sales growth.

3. Are there emerging markets for IV moxifloxacin?
Yes, Asia and Latin America are expanding use, driven by increasing bacterial infection rates and healthcare infrastructure growth.

4. What regulatory hurdles exist for expanding Avelox IV indications?
Additional clinical trials are often required, and approval processes can be lengthy. Differences across regions also complicate expansion.

5. How have patent expirations affected Avelox's market share?
Patents expired in key regions like the US, allowing generics to enter, which diminishes brand exclusivity and pressures prices.

References

[1] EvaluatePharma, 2022. Global Sales Data for IV Antibiotics.

[2] MarketWatch, 2023. Antibiotics Market Forecast.

[3] U.S. Patent and Trademark Office, 2012. Avelox Patent Expiry Notices.