Moxifloxacin hydrochloride - Generic Drug Details

What are the generic drug 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-three 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:	33
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	523
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
Johns Hopkins University	PHASE2
University of California, San Francisco	PHASE2
Tanta University	EARLY_PHASE1

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
Regcon Holdings	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	202525-001	Mar 6, 2015	AT1	RX	No	No
Upsher Smith Labs	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212616-001	Feb 10, 2021	AT1	RX	No	No
Dr Reddys	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	TABLET;ORAL	076938-001	Mar 4, 2014	AB	RX	No	Yes

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

International Patents for moxifloxacin hydrochloride

Country	Patent Number	Title	Estimated Expiration
South Korea	101587056
Mexico	2010012933	COMPOSICIONES FARMACEUTICAS QUE CONTIENEN UNA DROGA ANTIBIOTICA DE FLUOROQUINOLONA. (PHARMACEUTICAL COMPOSITIONS CONTAINING A FLUOROQUINOLONE ANTIBIOTIC DRUG.)
South Africa	201008543	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	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,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: July 27, 2025

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Introduction

Moxifloxacin Hydrochloride, a broad-spectrum fluoroquinolone antibiotic, is primarily used to treat respiratory tract infections, skin infections, and intra-abdominal infections. Approved in multiple markets, including the US and EU, it has established itself as a key player within the antimicrobial therapeutics landscape. This report analyzes the market dynamics influencing Moxifloxacin Hydrochloride and forecasts its financial trajectory, considering factors such as patent status, competition, regulatory environment, and global demand trends.

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Market Overview and Key Drivers

Global Antimicrobial Market Growth

The global antimicrobial market is projected to reach USD 55 billion by 2027, with a compound annual growth rate (CAGR) of approximately 3-4% (2023–2027) [1]. Moxifloxacin’s sales benefit from increasing prevalence of respiratory infections, particularly in aging populations with comorbidities.

Prescription Trends and Medical Guidelines

Clinical guidelines increasingly endorse fluoroquinolones like Moxifloxacin for community-acquired pneumonia and complicated skin infections, bolstering demand. However, recent shifts towards antibiotic stewardship aim to curb overuse, potentially moderating growth.

Off-Label Use and Emerging Indications

Ongoing research explores new indications including infectious diarrhea and tuberculosis, offering potential revenue streams if regulatory approved [2].

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Market Dynamics Influencing Moxifloxacin Hydrochloride

Patent Life and Generic Competition

Innovator patents on Moxifloxacin have generally expired or are nearing expiry in major markets (US patents expired in 2018), leading to a surge in generic competition. Generic formulations significantly reduce pricing and volume revenues for brand-name manufacturers, pressuring profit margins [3].

Pricing and Reimbursement Policies

Pricing strategies are heavily influenced by national reimbursement frameworks. Developed markets like the US and Europe employ negotiated drug prices, which limit revenue growth potential. Conversely, emerging markets with expanding healthcare infrastructure and less stringent price controls present opportunities.

Regulatory Environment and Drug Approvals

Regulatory agencies have tightened scrutiny over fluoroquinolones due to safety concerns, including tendon rupture and neuropsychiatric effects. The US FDA issued a warning in 2016, advising caution in prescribing fluoroquinolones [4]. Such warnings impact prescribing patterns and market size.

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Competitive Landscape

The market hosts several competitors offering alternative antibiotics, including Levofloxacin, Ciprofloxacin, and newer agents such as Delafloxacin. These alternatives challenge Moxifloxacin's market share, especially when considering safety profiles and resistance patterns.

Emergence of newer fluoroquinolones with improved safety profiles or pharmacokinetic properties may further influence Moxifloxacin’s market share.

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Market Challenges

• Antibiotic Resistance: Rising resistance diminishes effectiveness, particularly in bacteria like Streptococcus pneumoniae, leading to constrained sales [5].
• Safety Concerns: Adverse effect warnings have reduced prescriber confidence.
• Pricing Pressures: Competitive generic pricing, especially post-patent expiry, limits revenue potential.
• Regulatory Restrictions: Stringent markdowns in certain countries curtail market access.

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Financial Trajectory Forecast

Historical Sales Performance

Prior to patent expiry, Moxifloxacin’s global sales peaked at approximately USD 400 million annually, with US and European markets constituting major revenue sources [6]. Post-patent expiration, sales declined due to generic competition, with estimated reductions of 30–50% over a five-year span.

Projected Revenue Trends

Based on current trends, the following projections are relevant:

• Short-term (1–3 years): Decline in branded sales stabilizes as generics penetrate markets. Overall revenues expected to decline to USD 150–200 million annually.
• Medium-term (3–7 years): As patents in emerging markets expire, generic sales volume increases, but gross margins decrease. Revenues could stabilize around USD 100–150 million, primarily from established markets with limited price competition.
• Long-term (7+ years): Market saturation with generics, coupled with safety concerns and competition from newer agents, likely reduces Moxifloxacin's prominence. Revenues may plateau or decline further unless new indications are approved.

Strategic Opportunities

• Formulation Innovations: Development of new formulations, such as sustained-release or combination therapies, could recapture market share.
• New Indications: Investigating and securing approval for additional infections could extend product lifecycle.
• Market Diversification: Focus on emerging markets with growing healthcare access can yield incremental revenues.

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Conclusion

The financial outlook of Moxifloxacin Hydrochloride is characterized by a transition from branded dominance to a commoditized generic landscape, tempered by safety concerns and antimicrobial resistance. While immediate revenues face downward pressure, strategic expansion into new indications and markets could stabilize long-term profitability. Innovators and stakeholders must leverage regulatory expertise and clinical research to navigate evolving market dynamics effectively.

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Key Takeaways

• Patent expiries have shifted Moxifloxacin Hydrochloride from proprietary to generic markets, resulting in significant revenue contraction.
• Increasing antimicrobial resistance and safety warnings hinder further growth, demanding innovation and diversification.
• Emerging markets and new clinical indications present growth opportunities, contingent on regulatory approval and clinical validation.
• Prescriber preferences are influenced by safety profiles, necessitating ongoing pharmacovigilance and strategic positioning.
• Competitive pressure emphasizes the need for differentiation via formulations and expanding therapeutic applications.

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FAQs

1. How does patent expiry impact Moxifloxacin Hydrochloride’s market share?
Patent expiry typically leads to generic entry, drastically reducing prices and profit margins, transitioning market share from branded to generic manufacturers and decreasing overall revenue.

2. What are the primary safety concerns associated with Moxifloxacin?
Risks include tendinitis, tendon rupture, neuropsychiatric effects, and exacerbation of myasthenia gravis, leading to cautious prescribing and regulatory warnings.

3. Can new formulations revive Moxifloxacin's market?
Potentially, if innovative formulations improve safety, compliance, or efficacy, they can extend market relevance, especially if supported by robust clinical data.

4. What opportunities exist in emerging markets?
Growing healthcare infrastructure and increasing infection burdens open avenues for market expansion, provided regulatory hurdles are managed effectively.

5. How does antimicrobial resistance influence Moxifloxacin's future prospects?
Rising resistance reduces drug efficacy, leading to decreased prescriptions and prompting development of new agents or combination therapies to address resistant strains.

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References

[1] Grand View Research, "Antimicrobial Market Size & Share Analysis," 2022.

[2] World Health Organization, "Global Action Plan on Antimicrobial Resistance," 2015.

[3] Mondaq, "Patent Expiry and Generic Competition in the Pharmaceutical Industry," 2020.

[4] FDA Drug Safety Communication, "Fluoroquinolone Antibiotics and Tendinitis," 2016.

[5] CDC, "Antibiotic Resistance Threats in the United States," 2019.

[6] EvaluatePharma, "Top-Selling Antibiotics & Market Data," 2022.