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, Alembic, Apotex, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Gland, Lupin Ltd, Mankind Pharma, Pharmobedient, Regcon Holdings, Somerset Theraps Llc, 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-nine 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-four 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:	26
NDAs:	29
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	529
Patent Applications:	3,384
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
Research Insight LLC	PHASE4
Sanofi	PHASE1
Huashan Hospital	PHASE3

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
Msn	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	TABLET;ORAL	208682-001	Sep 22, 2017	AB	RX	No	No
Lupin Ltd	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	202867-001	Sep 4, 2014	AT1	RX	No	No
Sunshine	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	TABLET;ORAL	206295-001	Sep 28, 2018	AB	RX	No	No
Fresenius Kabi Usa	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	SOLUTION;INTRAVENOUS	205572-001	Apr 3, 2015		RX	Yes	Yes

Expired US Patents for MOXIFLOXACIN HYDROCHLORIDE

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	moxifloxacin hydrochloride	TABLET;ORAL	021085-001	Dec 10, 1999
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003

International Patents for MOXIFLOXACIN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
China	104814961	Pharmaceutical compositions containing a fluoroquinolone antibiotic drug
Taiwan	201000102	Improved pharmaceutical compositions containing a fluoroquinolone antibiotic drug
Japan	5509201
Argentina	072071

Supplementary Protection Certificates for MOXIFLOXACIN HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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

Market Dynamics and Financial Trajectory for Moxifloxacin Hydrochloride

Last updated: February 19, 2026

What is the Market Size and Growth Potential for Moxifloxacin Hydrochloride?

Moxifloxacin hydrochloride, a broad-spectrum fluoroquinolone antibiotic used to treat bacterial infections, faces a competitive landscape characterized by evolving regulatory policies, generics entry, and shifts in prescribing practices.

Global Market Size (2022):

• Estimated at USD 550 million.
• Projected Compound Annual Growth Rate (CAGR, 2023–2028): 2.5% to 4%.
• Driven by increasing bacterial resistance to older antibiotics and expanding indications, including respiratory, skin, and intra-abdominal infections.

Regional Breakdown (2022):	Region	Market Percentage	Notes
North America	40%	Led by U.S. hospital and outpatient demand
Europe	25%	Growing use in outpatient settings
Asia-Pacific	20%	Rapidly expanding due to healthcare infrastructure growth
Rest of World	15%	Limited by affordability and regulation

How Does Pricing and Patent Status Influence Financial Trajectory?

Patent Status:

• Patent protection for brand-name formulations expired between 2018 and 2020 globally.
• Generics entered markets shortly thereafter, reducing average price by 60–70%.

Pricing Trends:

• Branded Moxifloxacin: USD 3–5 per dose.
• Generics: USD 0.50–1.50 per dose.

Impact on Revenue:

• Revenue decline primarily from generics penetration.
• Still lucrative in emerging markets with higher prescribing rates and fewer generics.

Who Are the Key Market Players and Their Strategies?

Company	Market Share (Estimated, 2022)	Strategy
Bayer (Avelox)	50%	Continued expansion in developed markets, portfolio differentiation
Sandoz	20%	Focus on cost leadership, aggressive pricing
Teva	15%	Broaden distribution channels, increase access in emerging economies
Others	15%	Local manufacturers and niche marketing campaigns

What R&D and Regulatory Trends Shape the Market?

• Accelerated approvals for combination therapies and new indications.
• Focus on developing formulations with improved bioavailability and reduced resistance potential.
• Regulatory agencies (FDA, EMA) favor generics but demand stricter bioequivalence and safety data.

How Will Market Dynamics Affect Financial Performance?

Factor	Effect on Financials
Patent expirations	Leads to revenue decline from brand formulations, rise in generic sales
Pricing pressure	Reduces profit margins, especially in mature markets
Increased competition from biosimilars and generics	Drives down prices, diminishes revenue per unit
Expanded indications and new formulations	May offset declines, create new revenue streams

What Are the Future Revenue Drivers?

• Entry of combination products integrating Moxifloxacin with other antibiotics or therapeutic agents.
• Introduction of reformulations or delivery methods with improved compliance profiles.
• Growth in markets with rising bacterial infection incidence and less stringent patent enforcement.

Key Takeaways

• The global market for Moxifloxacin hydrochloride was USD 550 million in 2022, with slow-to-moderate growth expected through 2028.
• Patent expiries and generic competition have led to significant price erosion and revenue decline.
• North America and Europe comprise the majority of revenue, though Asia-Pacific presents growth opportunities due to healthcare expansion.
• Strategic focus on reformulations, new indications, and combination products could offset losses from patent expirations.
• Regulatory policies favor generic entry but require quality and bioequivalence standards.

FAQs

1. What factors could accelerate growth in the Moxifloxacin market?
Expansion of indications, improved formulations, and increased use in emerging markets.

2. How vulnerable is the market to generic competition?
Highly vulnerable; generic entry has reduced average prices and margins.

3. Are there upcoming regulatory hurdles?
Regulatory agencies are increasing bioequivalence and safety requirements, possibly delaying new formulations’ approvals.

4. Which regions offer the greatest revenue potential?
Asia-Pacific, due to market growth and less saturated competition, offers significant upside.

5. Will new formulations or combination therapies sustain profitability?
Yes, if they demonstrate clinical advantages and gain regulatory approval, they can sustain or grow revenue streams.

References

1. MarketResearch.com. (2023). Global Fluoroquinolone Antibiotics Market Report.
2. IQVIA. (2022). Prescription Trends and Market Share Data.
3. United States Food and Drug Administration. (2022). Bioequivalence Guidelines for Generic Drugs.
4. European Medicines Agency. (2022). Regulations on Antibiotic Approvals and Generic Entry.
5. ReportLinker. (2023). Latin America and Asia-Pacific Pharmaceutical Markets Overview.