MOXIFLOXACIN HYDROCHLORIDE - Generic Drug Details

What are the generic sources for moxifloxacin hydrochloride and what is the scope of freedom to operate?

Moxifloxacin hydrochloride is the generic ingredient in six branded drugs marketed by Harrow Eye, Adaptis, Alembic, Apotex, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Lupin Ltd, Mylan, Upsher Smith Labs, Bayer Hlthcare, Fresenius Kabi Usa, Mylan Labs Ltd, Aurobindo Pharma Ltd, Chartwell Rx, Crossmedika Sa, Dr Reddys, Hetero Labs Ltd V, MSN, Natco, Sunshine, Teva Pharms Usa, and Torrent, and is included in twenty-six NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Moxifloxacin hydrochloride has twenty-three patent family members in fifteen countries.

There are seventeen drug master file entries for moxifloxacin hydrochloride. Thirty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for MOXIFLOXACIN HYDROCHLORIDE

International Patents:	23
US Patents:	2
Tradenames:	6
Applicants:	23
NDAs:	26
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	486
Patent Applications:	2,539
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOXIFLOXACIN HYDROCHLORIDE
What excipients (inactive ingredients) are in MOXIFLOXACIN HYDROCHLORIDE?	MOXIFLOXACIN HYDROCHLORIDE excipients list
DailyMed Link:	MOXIFLOXACIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for MOXIFLOXACIN HYDROCHLORIDE

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

Sponsor	Phase
North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences	Phase 3
Christian Medical College, Vellore, India	Phase 3
Indian Council of Medical Research	Phase 3

See all MOXIFLOXACIN HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for MOXIFLOXACIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		0.5%	SOLUTION; OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for MOXIFLOXACIN HYDROCHLORIDE

Drug Class

Fluoroquinolone Antibacterial Quinolone Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for MOXIFLOXACIN HYDROCHLORIDE

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for MOXIFLOXACIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MOXEZA	Ophthalmic Solution	moxifloxacin hydrochloride	0.5%	022428	1	2012-02-29
VIGAMOX	Ophthalmic Solution/Drops	moxifloxacin hydrochloride	0.5%	021598	1	2005-12-22

US Patents and Regulatory Information for MOXIFLOXACIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	SOLUTION;INTRAVENOUS	205572-001	Apr 3, 2015		RX	Yes	Yes
Bayer Hlthcare	AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	moxifloxacin hydrochloride	SOLUTION;INTRAVENOUS	021277-001	Nov 30, 2001		DISCN	Yes	No
Alembic	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	209469-001	Feb 13, 2019	AT1	RX	No	No
Dr Reddys	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	TABLET;ORAL	076938-001	Mar 4, 2014	AB	RX	No	Yes
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003	AT1	RX	Yes	Yes
Teva Pharms Usa	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	TABLET;ORAL	077437-001	Feb 18, 2014	AB	RX	No	No

Expired US Patents for MOXIFLOXACIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003	5,607,942*PED
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	4,990,517
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003	4,990,517*PED
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010	4,990,517*PED
Bayer Hlthcare	AVELOX	moxifloxacin hydrochloride	TABLET;ORAL	021085-001	Dec 10, 1999	5,607,942

International Patents for MOXIFLOXACIN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Mexico	2010012933	COMPOSICIONES FARMACEUTICAS QUE CONTIENEN UNA DROGA ANTIBIOTICA DE FLUOROQUINOLONA. (PHARMACEUTICAL COMPOSITIONS CONTAINING A FLUOROQUINOLONE ANTIBIOTIC DRUG.)
South Korea	20110039219	PHARMACEUTICAL COMPOSITIOS CONTAINING A FLUOROQUINOLONE ANTIBIOTIC DRUG
Brazil	PI0914971	composições farmacêuticas que contêm fármaco antibiótico de fluoroquinolonas
Taiwan	I544934
South Korea	101587056
Taiwan	201000102	Improved pharmaceutical compositions containing a fluoroquinolone antibiotic drug

Supplementary Protection Certificates for MOXIFLOXACIN HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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,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	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
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	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

MOXIFLOXACIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Moxifloxacin Hydrochloride

Introduction to Moxifloxacin Hydrochloride

Moxifloxacin hydrochloride is a broad-spectrum antibiotic belonging to the fluoroquinolone class, widely used in the treatment of various bacterial infections. Here, we will delve into the market dynamics, financial trajectory, and key factors influencing the moxifloxacin hydrochloride market.

Market Size and Growth

The global moxifloxacin hydrochloride market is anticipated to experience a mixed growth trajectory over the forecast period. As of 2024, the market size is estimated to be around $117 million[3].

• Forecast Period: The market is projected to grow from 2024 to 2030, although at a relatively slow Compound Annual Growth Rate (CAGR) of -0.8% due to various market dynamics[3].
• Historical Data: The historical period from 2019 to 2023 has shown significant fluctuations, with the market size varying based on regional demand and competitive landscape[1][2].

Market Segmentation

The moxifloxacin hydrochloride market is segmented based on several key factors:

By Type

• The market is categorized into different purity grades: 98.0%-99.5%, 99.5%-99.9%, and above 99.9%[4].
• These segments are crucial as they determine the quality and application of the drug.

By Dosage Type

• The drug is available in various dosage forms including oral tablets, injections, and ophthalmic drugs[3][4].
• Each dosage type has its own market share and growth prospects, with ophthalmic drugs being a significant segment due to the treatment of bacterial conjunctivitis and prevention of post-operative endophthalmitis[2].

By Application

• The primary applications include the treatment of bacterial conjunctivitis and the prevention of post-operative endophthalmitis, among other bacterial infections[2].
• The demand for moxifloxacin hydrochloride eye drops is particularly high due to its efficacy in ophthalmic treatments.

By Geography

• The market is segmented into major regions such as North America, Europe, Asia-Pacific, South America, and the Middle East & Africa[1][2][4].
• Regional analysis reveals varying growth rates and market sizes, with Asia-Pacific often showing significant potential due to a large patient population and increasing healthcare expenditure.

Market Drivers

Several factors drive the growth of the moxifloxacin hydrochloride market:

Increasing Prevalence of Bacterial Infections

• The rising incidence of bacterial infections, particularly in developing countries, drives the demand for effective antibiotics like moxifloxacin hydrochloride[2].

Advancements in Healthcare Infrastructure

• Improvements in healthcare infrastructure and access to medical facilities in emerging markets contribute to the increased use of moxifloxacin hydrochloride[1].

Regulatory Approvals

• Regulatory approvals and compliance with international standards enhance the market credibility and acceptance of moxifloxacin hydrochloride products[4].

Market Restraints

Despite the drivers, there are several restraints affecting the market:

Antibiotic Resistance

• The growing concern of antibiotic resistance is a significant restraint, as it reduces the efficacy of moxifloxacin hydrochloride over time[5].

Side Effects and Safety Concerns

• Side effects and safety concerns associated with fluoroquinolones, including moxifloxacin hydrochloride, can limit market growth[5].

Competitive Landscape

• The presence of generic alternatives and other antibiotics in the market can reduce the market share of moxifloxacin hydrochloride[3].

Competitive Landscape

The competitive landscape of the moxifloxacin hydrochloride market is characterized by:

Key Players

• Major players include Actavis UK, MERCK, Cayman, Allergan, Tecoland, BOC Sciences, Aurobindo, and NIVIKA Chemo Pharma, among others[3][4].
• These companies engage in strategies such as new product launches, expansions, mergers & acquisitions, and partnerships to maintain their market position.

Market Share

• The top five players hold approximately 60% of the market share, indicating a somewhat concentrated market[3].

Financial Analysis

The financial performance of the moxifloxacin hydrochloride market can be summarized as follows:

Revenue Forecast

• The market is expected to decline slightly from $117 million in 2024 to $111.5 million by 2030, reflecting a CAGR of -0.8%[3].

Regional Revenue

• Regional markets such as North America, Europe, and Asia-Pacific contribute significantly to the overall revenue, with each region showing different growth trajectories[1][4].

Company Financials

• Key players' financials, including revenue, gross margin, and market share, are crucial indicators of the market's financial health. These metrics are often analyzed to understand the competitive positioning and growth strategies of the companies involved[1].

Regional Analysis

The regional analysis provides insights into the market's performance across different geographies:

North America

• This region is a significant market due to advanced healthcare infrastructure and high awareness of antibiotic treatments[1][4].

Europe

• Europe also holds a substantial share, driven by stringent regulatory standards and a well-established healthcare system[1][4].

Asia-Pacific

• The Asia-Pacific region is expected to show robust growth due to a large population, increasing healthcare expenditure, and improving healthcare infrastructure[1][4].

Future Prospects

The future prospects of the moxifloxacin hydrochloride market are influenced by several factors:

Technological Advancements

• Continuous research and development in pharmaceuticals could lead to more efficient and safer antibiotics, potentially impacting the market for moxifloxacin hydrochloride[5].

Regulatory Environment

• Changes in regulatory policies and guidelines can significantly affect the market dynamics and the approval process for new products[4].

Market Opportunities

• Emerging markets and untapped regions offer opportunities for growth, especially with the increasing demand for quality healthcare services[1].

Key Takeaways

• Market Size and Growth: The global moxifloxacin hydrochloride market is projected to decline slightly from 2024 to 2030.
• Segmentation: The market is segmented by type, dosage type, application, and geography.
• Drivers and Restraints: Increasing bacterial infections and healthcare infrastructure advancements drive the market, while antibiotic resistance and side effects are significant restraints.
• Competitive Landscape: Key players dominate the market, with strategies focused on new product launches and partnerships.
• Financial Analysis: The market is expected to decline at a CAGR of -0.8% from 2024 to 2030.
• Regional Analysis: North America, Europe, and Asia-Pacific are key regions, each with different growth prospects.

FAQs

Q: What is the projected market size of moxifloxacin hydrochloride by 2030?

• The market is projected to be around $111.5 million by 2030[3].

Q: What are the main types of moxifloxacin hydrochloride?

• The main types are categorized into purity grades: 98.0%-99.5%, 99.5%-99.9%, and above 99.9%[4].

Q: Which dosage forms are most common for moxifloxacin hydrochloride?

• The drug is available in oral tablets, injections, and ophthalmic drugs, with ophthalmic drugs being a significant segment[2][3].

Q: What are the primary applications of moxifloxacin hydrochloride?

• The primary applications include the treatment of bacterial conjunctivitis and the prevention of post-operative endophthalmitis[2].

Q: Who are the key players in the moxifloxacin hydrochloride market?

• Key players include Actavis UK, MERCK, Cayman, Allergan, Tecoland, BOC Sciences, Aurobindo, and NIVIKA Chemo Pharma, among others[3][4].

Sources

1. Cognitive Market Research: Moxifloxacin HCl Market Report 2024 (Global Edition)[1].
2. Market Research Intellect: Global Moxifloxacin Hydrochloride Eye Drops Market Size, Scope[2].
3. Valuates Reports: Global Moxifloxacin HCl Market Insights, Forecast to 2030[3].
4. IndustryARC: Moxifloxacin HCl Market - Forecast(2024 - 2030)[4].
5. ResearchGate: Moxifloxacin Hydrochloride[5].