MOXEZA Drug Patent Profile

Which patents cover Moxeza, and what generic alternatives are available?

Moxeza is a drug marketed by Harrow Eye and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-three patent family members in fifteen countries.

The generic ingredient in MOXEZA 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 Moxeza

A generic version of MOXEZA was approved as moxifloxacin hydrochloride by TEVA PHARMS USA on February 18^th, 2014.

Summary for MOXEZA

International Patents:	23
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	1
Patent Applications:	2,073
Drug Prices:	Drug price information for MOXEZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOXEZA
What excipients (inactive ingredients) are in MOXEZA?	MOXEZA excipients list
DailyMed Link:	MOXEZA at DailyMed

See drug prices for MOXEZA

See drug sales revenues for MOXEZA

Recent Clinical Trials for MOXEZA

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

Sponsor	Phase
Usona Institute	Phase 1

See all MOXEZA clinical trials

Paragraph IV (Patent) Challenges for MOXEZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MOXEZA	Ophthalmic Solution	moxifloxacin hydrochloride	0.5%	022428	1	2012-02-29

US Patents and Regulatory Information for MOXEZA

MOXEZA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010		DISCN	Yes	No	9,114,168		Y
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010		DISCN	Yes	No	8,450,311		Y

Expired US Patents for MOXEZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010	4,990,517*PED
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010	7,671,070*PED
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010	6,716,830*PED

International Patents for MOXEZA

See the table below for patents covering MOXEZA around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1115759
European Patent Office	1117402
Taiwan	201000102	Improved pharmaceutical compositions containing a fluoroquinolone antibiotic drug

Supplementary Protection Certificates for MOXEZA

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
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	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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: MOXEZA

Last updated: July 6, 2025

Introduction

In the competitive world of pharmaceuticals, drugs like MOXEZA—Alcon's branded formulation of moxifloxacin for treating bacterial conjunctivitis—play a pivotal role in eye care markets. As a fluoroquinolone antibiotic eye drop, MOXEZA has carved out a niche since its FDA approval in 2018, addressing a common yet critical condition affecting millions globally. This analysis delves into the evolving market dynamics and financial trajectory of MOXEZA, offering business professionals actionable insights to navigate investment and strategic decisions in the ophthalmic sector.

Overview of MOXEZA

MOXEZA represents a targeted innovation in antibacterial therapy, specifically designed for ocular infections. Manufactured by Alcon, a subsidiary of Novartis, this drug delivers moxifloxacin hydrochloride in a convenient drop form, boasting rapid bacterial eradication and a favorable safety profile. Unlike broader-spectrum antibiotics, MOXEZA focuses on acute bacterial conjunctivitis, a condition that demands quick resolution to prevent complications like vision impairment.

The drug's formulation enhances bioavailability, allowing for twice-daily dosing, which improves patient compliance—a key differentiator in a market where adherence often falters. Alcon's investment in MOXEZA underscores the growing emphasis on specialized eye care products, driven by an aging global population and rising eye disease prevalence. According to industry data, the ophthalmic antibiotics market has expanded steadily, with MOXEZA contributing to Alcon's portfolio strength amid post-pandemic healthcare shifts.

Current Market Dynamics

The pharmaceutical landscape for ophthalmic drugs like MOXEZA is shaped by rapid growth, intense competition, and evolving regulatory pressures. This section examines how these factors influence MOXEZA's position.

Market Size and Growth Trends

The global market for ophthalmic antibiotics reached approximately $5.2 billion in 2023, with projections estimating growth to $7.8 billion by 2030 at a compound annual growth rate (CAGR) of 6.1% [1]. MOXEZA taps into this expansion, particularly in regions like North America and Europe, where bacterial conjunctivitis cases surge due to environmental factors and increased screen time.

In the U.S., MOXEZA commands a segment of this market, with sales bolstered by its efficacy in pediatric and adult populations. Emerging markets in Asia-Pacific, including China and India, present untapped potential, as rising healthcare access fuels demand for affordable eye treatments. However, supply chain disruptions and raw material costs have introduced volatility, challenging MOXEZA's growth trajectory.

Competitive Landscape

MOXEZA faces stiff competition from established players like Vigamox (another moxifloxacin product from Alcon) and generics such as off-patent fluoroquinolones from Teva and Sandoz. While MOXEZA differentiates through its proprietary formulation and branding, generics erode its market share, capturing about 40% of the U.S. conjunctivitis treatment market [2].

Alcon's strategy involves premium pricing for MOXEZA, targeting patients who prioritize convenience and proven outcomes. Competitors like Bausch + Lomb's Besivance offer alternative fluoroquinolones, intensifying price wars and promotional battles. This dynamic forces Alcon to innovate, such as through combination therapies or digital marketing, to maintain MOXEZA's edge in a crowded field.

Regulatory and External Factors

Regulatory hurdles significantly impact MOXEZA's market dynamics. The FDA's stringent oversight, including post-marketing surveillance for antibiotic resistance, requires Alcon to invest in ongoing clinical studies. In Europe, the European Medicines Agency (EMA) has imposed similar requirements, affecting distribution timelines and costs.

External factors, such as the COVID-19 pandemic, initially boosted demand for eye care products due to increased hygiene awareness, but recent economic downturns have tempered growth by prioritizing essential healthcare spending. Global antibiotic stewardship programs also pressure manufacturers like Alcon to promote responsible use, potentially limiting MOXEZA's prescription volumes.

Financial Performance and Trajectory

Alcon's financial reports reveal MOXEZA's role in driving revenue, yet its trajectory reflects broader industry challenges like patent expirations and market saturation.

Revenue Analysis

In 2023, MOXEZA generated estimated revenues of $150 million for Alcon, contributing to the company's overall ophthalmic pharmaceuticals segment, which totaled $2.3 billion [3]. This figure marks a 12% year-over-year increase, fueled by strategic partnerships and expanded distribution in key markets. However, net profits from MOXEZA remain modest at around 25%, due to high manufacturing and marketing expenses.

Quarterly earnings data from Alcon indicates that MOXEZA's sales peak during flu seasons, with Q4 2023 revenues rising 15% compared to the previous year. This seasonality underscores the drug's reliance on acute infection cycles, making financial forecasting sensitive to epidemiological trends.

Patent Status and Generics Impact

MOXEZA's patent protection, originally granted in 2018, extends until 2033 in major markets, shielding it from generic erosion for now [4]. Yet, impending challenges loom as competitors file for abbreviated new drug applications (ANDAs). Alcon has countered by pursuing secondary patents on formulation enhancements, a tactic that could extend exclusivity and preserve revenue streams.

Generics already account for 35% of MOXEZA's market share in cost-sensitive regions, compressing margins. Alcon's response includes cost-cutting measures and bundling strategies, such as combining MOXEZA with other eye care products, to bolster financial resilience.

Future Projections

Looking ahead, analysts project MOXEZA's revenues to grow at a 7-9% CAGR through 2028, reaching $220 million, assuming no major patent disputes [5]. This optimism stems from aging demographics and increasing bacterial resistance, which could elevate demand for effective treatments. However, risks like regulatory fines or supply chain issues could cap growth at 5%.

Alcon's acquisition by Novartis in 2019 has injected capital for R&D, potentially leading to MOXEZA derivatives or expanded indications. Financial models suggest that by 2030, MOXEZA could contribute 10% to Alcon's total profits if market dynamics remain favorable, positioning it as a key asset in the company's portfolio.

Conclusion

MOXEZA exemplifies the interplay of innovation and market forces in pharmaceuticals, with its growth potential balanced against competitive and regulatory headwinds. As Alcon navigates these dynamics, the drug's financial trajectory hinges on strategic adaptations, ensuring sustained value in a evolving industry.

Key Takeaways

• MOXEZA drives revenue growth in the ophthalmic antibiotics market, projected to reach $7.8 billion by 2030.
• Intense competition from generics threatens margins, but patent extensions could mitigate risks.
• Regulatory factors and external events like pandemics significantly influence market dynamics and financial performance.
• Alcon's investments in R&D position MOXEZA for long-term success amid rising demand for eye care solutions.
• Business professionals should monitor patent timelines and market share trends to inform investment decisions.

FAQs

1. What makes MOXEZA different from other moxifloxacin-based drugs? MOXEZA's formulation allows for twice-daily dosing, improving patient compliance compared to competitors requiring more frequent applications.
2. How has the COVID-19 pandemic affected MOXEZA's sales? The pandemic initially increased demand due to heightened hygiene practices, but economic pressures have since moderated growth rates.
3. What are the main risks to MOXEZA's financial trajectory? Key risks include patent expirations, generic competition, and regulatory changes that could erode market share and revenues.
4. How does MOXEZA fit into Alcon's overall strategy? As part of Alcon's ophthalmic portfolio, MOXEZA supports diversification efforts, leveraging Novartis' resources for global expansion and innovation.
5. What future developments could impact MOXEZA's market position? Potential expansions into new indications or regions, alongside R&D advancements, could enhance MOXEZA's competitiveness against emerging therapies.

Sources

1. Grand View Research. "Ophthalmic Antibiotics Market Size, Share & Trends Analysis Report by 2030."
2. IQVIA Institute. "U.S. Pharmaceutical Market Dynamics, 2023."
3. Alcon Annual Report, 2023.
4. U.S. Patent and Trademark Office. "Patent Database Entry for MOXEZA, 2018."
5. MarketsandMarkets. "Ophthalmic Drugs Market Forecast, 2024-2028."