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-four 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
Bayer Hlthcare	AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	moxifloxacin hydrochloride	SOLUTION;INTRAVENOUS	021277-001	Nov 30, 2001
Bayer Hlthcare	AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	moxifloxacin hydrochloride	SOLUTION;INTRAVENOUS	021277-001	Nov 30, 2001
Bayer Hlthcare	AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	moxifloxacin hydrochloride	SOLUTION;INTRAVENOUS	021277-001	Nov 30, 2001

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
Brazil	9605968
China	1061348
European Patent Office	0780390	Modification cristalline du CDCH, procédé pour sa préparation et compositions pharmaceutiques la contenant (Crystalline modification of CDCH, process for its preparation and pharmaceutical compositions containing it)
Malaysia	117492	NEW CRYSTAL MODIFICATION OF CDCH, A PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL FORMULATIONS COMPRISING THIS MODIFICATION
Norway	306725
Taiwan	270119
Yugoslavia	49485

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	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
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	C300111	Netherlands		PRODUCT NAME: MOXIFLOXACINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER MOXIFLOXACINEHYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 28118 RVG 28119 20021017; 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)
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

Moxifloxacin HCL Market Dynamics and Financial Trajectory: AVELOX in Sodium Chloride 0.8% in Plastic Container

Introduction to Moxifloxacin HCL

Moxifloxacin HCL, marketed under the brand name AVELOX among others, is a fourth-generation fluoroquinolone antibiotic developed by Bayer AG. It is used to treat a variety of bacterial infections, including respiratory infections, urinary tract infections, and skin infections.

Market Segmentation

The Moxifloxacin HCL market is segmented based on several key factors:

By Product

• Qualified grade
• First grade
• Excellence grade[1][4].

By Dosage Form

• Oral tablets
• Parenteral (intravenous) formulations
• Ophthalmic drugs (eye drops)[1][4].

By Application

• Bronchitis
• Pneumonia
• Sinusitis
• Pelvic inflammatory disease
• Other bacterial infections[1].

Market Dynamics

Drivers

• The rising prevalence of bacterial infections such as respiratory infections, urinary tract infections, and pneumonia is a significant driver for the Moxifloxacin HCL market. These infections are increasingly common and require effective antibiotic treatments[1].
• The relatively low cost of Moxifloxacin HCL compared to other antibiotics is another factor fueling market growth. This makes it an attractive option for both patients and healthcare providers[1].

Restraints

• Side effects associated with antibiotics, including abdominal discomfort, diarrhea, vomiting, nausea, and mouth sores, can negatively impact the market. These adverse effects can lead to reduced patient compliance and decreased prescription rates[1].
• The high cost of treatment for certain conditions, such as Small Bowel Syndrome (SBS), can also restrain market growth. Despite the overall lower cost of Moxifloxacin HCL, the comprehensive treatment costs can be prohibitive for some patients[1].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the Moxifloxacin HCL market:

• Supply Chain Disruptions: Lockdowns, travel bans, and business shutdowns have affected global supply chains, leading to delays in product deliveries and potential slumps in future sales[1].
• Increased Demand: On the other hand, the pandemic has led to an increased incidence of secondary bacterial infections, which can drive up the demand for antibiotics like Moxifloxacin HCL[1].

Financial Trajectory

Market Size and Growth

• The global Moxifloxacin HCL market is forecasted to grow at a compound annual growth rate (CAGR) of XX% from 2024 to 2031. The market size in 2023 was estimated to be US$ XX Million and is expected to reach US$ XX Million by 2031[1][4].

Revenue Forecast

• The revenue forecast for Moxifloxacin HCL includes significant growth driven by increasing demand for effective antibiotic treatments. The market is expected to see substantial revenue growth across all major regions, including North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America[1][4].

Competitive Landscape

• Key players in the Moxifloxacin HCL market include Bayer, Rivopharm, Actavis UK, Merck, Cayman, Allergan, Tecoland, BOC Sciences, Aurobindo, and NIVIKA Chemo Pharma. These companies are focusing on expanding their product portfolios and improving their market presence through strategic partnerships and innovations[1][4].

Regional Analysis

The Moxifloxacin HCL market is analyzed across five major regions:

North America

• This region is expected to contribute significantly to the global market due to high healthcare spending and a well-established pharmaceutical industry[1][4].

Europe

• Europe is another key market, driven by a large patient population and stringent regulatory frameworks that ensure the quality and safety of pharmaceutical products[1][4].

Asia-Pacific

• The Asia-Pacific region is anticipated to experience rapid growth due to increasing healthcare infrastructure and a large population base with growing healthcare needs[1][4].

Middle East & Africa and Latin America

• These regions are also expected to contribute to the market growth, driven by improving healthcare systems and increasing awareness of antibiotic treatments[1][4].

Pharmacological and Clinical Aspects

Mechanism of Action

• Moxifloxacin HCL works by inhibiting DNA gyrase and topoisomerase IV, which are essential enzymes for bacterial DNA replication and transcription[3].

Safety Profile

• The safety profile of Moxifloxacin HCL is well-documented. It is generally well-tolerated, with rare adverse events reported. Topical ocular administration shows low systemic exposure, ensuring a substantial margin of safety[3].

Pharmacokinetics

• Clinical pharmacokinetic studies have been conducted for oral and intravenous administrations. Topical ocular administration studies have also been performed to assess systemic exposure and drug levels in the tear film[3].

Key Takeaways

• The Moxifloxacin HCL market is driven by the rising prevalence of bacterial infections and the relatively low cost of the medication.
• The market faces restraints due to side effects and high treatment costs for certain conditions.
• The COVID-19 pandemic has had mixed effects on the market, with supply chain disruptions and increased demand for antibiotics.
• The market is expected to grow significantly across all major regions.
• Key players are focusing on expanding their product portfolios and improving market presence.

FAQs

What are the primary drivers of the Moxifloxacin HCL market?

The primary drivers include the rising prevalence of bacterial infections and the relatively low cost of Moxifloxacin HCL compared to other antibiotics.

How has the COVID-19 pandemic impacted the Moxifloxacin HCL market?

The pandemic has caused supply chain disruptions but has also increased the demand for antibiotics due to secondary bacterial infections.

What are the common dosage forms of Moxifloxacin HCL?

Moxifloxacin HCL is available in oral tablets, parenteral (intravenous) formulations, and ophthalmic drugs (eye drops).

Which regions are expected to dominate the Moxifloxacin HCL market?

North America, Europe, and the Asia-Pacific region are expected to be the dominant markets due to their large patient populations and well-established pharmaceutical industries.

What is the mechanism of action of Moxifloxacin HCL?

Moxifloxacin HCL works by inhibiting DNA gyrase and topoisomerase IV, essential enzymes for bacterial DNA replication and transcription.

Cited Sources

1. The Insight Partners: Moxifloxacin HCL Market Key Players Analysis 2031
2. Avalo Therapeutics: Avalo Reports Second Quarter 2024 Financial Results and Provides Business Updates
3. Decentralised Procedure RMS Public Assessment Report: Scientific Assessment of Moxifloxacin Hydrochloride
4. Cognitive Market Research: Moxifloxacin HCl Market Report 2024 (Global Edition)