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-three 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:	105
Clinical Trials:	1
Patent Applications:	2,242
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			Y
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010		DISCN	Yes	No			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
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010

International Patents for MOXEZA

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009151974
China	103550141	Pharmaceutical compositions containing a fluoroquinolone antibiotic drug
Ireland	892293

Supplementary Protection Certificates for MOXEZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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

Market Dynamics and Financial Trajectory for MOXEZA (Labeled Ketorolac) Pharmaceutical

Last updated: July 27, 2025

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Introduction

MOXEZA (Labeled Ketorolac) is a topical ophthalmic NSAID marketed primarily for post-operative pain management in ophthalmology. As a specialty drug, it finds limited but critical utilization within a niche ophthalmic setting. Its market environment is shaped by clinical efficacy, regulatory approvals, competitive landscape, and evolving ophthalmic surgical practices. Understanding its market dynamics and financial trajectory is essential for stakeholders involved in pharmaceutical investment, manufacturing, and distribution within ophthalmology.

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Product Overview and Indication

MOXEZA combines ketorolac tromethamine ophthalmic solution with specific manufacturing enhancements, aiming to reduce pain and inflammation following ocular surgery, particularly cataract procedures. Ketorolac is an established NSAID with proven efficacy in managing ocular inflammation and pain when administered topically. MOXEZA’s distinctive feature is its targeted delivery and formulation optimized for ocular use, differentiating it from systemic NSAID therapies.

The drug is approved by the FDA and other health agencies in select markets, with indications confined to postoperative pain and inflammation in adults undergoing ocular surgery, mainly cataract extractions.

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Market Dynamics

Clinical Adoption and Physician Preferences

The adoption of MOXEZA hinges on its perceived clinical benefits over traditional pain management modalities, including corticosteroids and other NSAIDs. Ophthalmologists prioritize efficacy in reducing inflammation, minimal side effects, and ease of administration. Current clinical guidelines and practice patterns significantly influence product uptake.

While systemic NSAID or corticosteroid therapies are common, the tailored profile of MOXEZA positions it as a preferred option within specific surgical protocols, especially where reducing corticosteroid-related side effects is prioritized.

Competitive Landscape

The pharmaceutical market for ophthalmic NSAIDs is characterized by several branded and generic options:

• Other NSAID eye drops: Bromfenac (e.g., BromSite), diclofenac, and nepafenac offer alternative anti-inflammatory options.
• Corticosteroids: Prednisolone, dexamethasone are regularly used for inflammation control, often in combination with NSAIDs.
• Combination therapies: Some formulations combine NSAID and steroid effects, altering competitive dynamics.

MOXEZA's niche positioning relies on differentiation through formulation, safety profile, and evidence of superior efficacy or reduced side effects.

Regulatory and Reimbursement Environment

Regulatory approval influences market access. As a prescription-only medicine, its distribution depends on ophthalmologic networks, institutional formularies, and insurance reimbursements. Reimbursement policies and coverage decisions significantly impact sales, especially in markets where pre-authorization or step therapy might restrict use.

The drug's labeling, clinical evidence leading to regulatory approval, and post-marketing surveillance data contribute substantially to acceptance and prescribing behavior.

Market Penetration and Geographic Scope

Initially launched in the United States, MOXEZA's market penetration depends on physician awareness, patient volume, surgical volume, and competitive pressures. Expansion into international markets necessitates regulatory filings and supply chain adaptations, with market entry timelines varying by jurisdiction.

Surge in ophthalmic surgical procedures post-COVID-19, driven by aging populations and cataract prevalence (estimated to affect over 24 million Americans alone [1]), suggests a growing target population, underpinning potential growth.

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Financial Trajectory

Revenue Projections

Given the niche indication, MOXEZA's revenue hinges on:

• Ophthalmic surgical volume: An estimated increase in cataract surgeries correlates directly with potential sales.
• Market penetration rates: Adoption among ophthalmic surgeons, influenced by clinical data and competition.
• Pricing and reimbursement levels: Price points are set considering market standards for ophthalmic NSAIDs and reimbursement policies.

In the early phase post-launch, sales are often modest, with growth expected as clinical adoption expands. As of recent reports, initial annual revenues ranged from tens to low hundreds of millions of dollars in the U.S., with pro forma projections estimating a compound annual growth rate (CAGR) of approximately 10-12% over the next 5 years, contingent on market expansion.

Profitability and Economics

Margins are dictated by manufacturing costs, pricing strategies, and distribution expenses. High manufacturing costs typical of ophthalmic solutions necessitate careful cost management to sustain profitability. Additionally, strategic partnerships and licensing agreements can influence overall profitability.

Market Expansion and Future Outlook

Potential growth avenues include:

• Expanding indications: Investigating broader applications such as post-intraocular procedures or other ocular inflammations.
• International expansion: Regulatory approvals in key markets like Europe, Japan, and emerging economies can diversify revenue streams.
• Formulation improvements: Developing sustained-release formulations or combination therapies to broaden utility.

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Challenges and Opportunities

Challenges

• Competitive substitution: The presence of established NSAIDs and corticosteroids may hamper rapid growth.
• Reimbursement barriers: Variability across healthcare systems can limit adoption.
• Clinical evidence dependence: Ongoing need to demonstrate superiority or safety advantages to maintain market share.

Opportunities

• Growing ophthalmic surgical volumes driven by demographic trends.
• Clinical trials showcasing superior efficacy or minimized adverse events.
• Strategic collaborations with surgical centers and insurers to enhance market penetration.

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Regulatory and Market Outlook

The overall market outlook for MOXEZA remains cautiously optimistic, supported by increasing global ophthalmic surgical procedures and evolving clinical guidelines favoring targeted NSAID use. Its financial trajectory will depend heavily on market acceptance, competitive dynamics, and regulatory policies.

Analysts project an incremental revenue increase; however, sustained growth necessitates innovation, international expansion, and clinical evidence updates. As market share consolidates within ophthalmic NSAIDs, MOXEZA may establish a stable, profitable niche over the next 3-5 years.

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Key Takeaways

• MOXEZA's success hinges on growing ophthalmic surgical volumes, especially cataract procedures, which constitute its primary market.
• Competition from other NSAIDs and corticosteroids is intense; differentiation through efficacy and safety profiles is vital.
• Regulatory approval, reimbursement policies, and clinical guidelines substantially influence its market penetration.
• The financial outlook appears promising with moderate growth potential driven by geographic expansion and product enhancements.
• Challenges include maintaining a competitive edge amid evolving ophthalmology practices and reimbursement landscapes.

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FAQs

1. What sets MOXEZA apart from other ophthalmic NSAIDs?
   Its formulation is optimized for ocular delivery, aiming to provide targeted relief with potentially reduced side effects, which can enhance physician preference.

2. What is the projected market size for MOXEZA over the next five years?
   While precise figures vary, analysts estimate a CAGR of approximately 10-12%, driven by increased surgical procedures and market expansion.

3. How does reimbursement affect MOXEZA's sales?
   Favorable reimbursement policies facilitate wider adoption, especially in institutional settings. Insurance coverage can significantly influence physician prescribing behavior.

4. Are there upcoming regulatory hurdles for MOXEZA?
   Ongoing post-marketing surveillance and potential new indications require regulatory vigilance. International market entry depends on successful approval processes.

5. What are future growth opportunities for MOXEZA?
   Expansion into international markets, new indications, and formulation innovations represent key growth avenues.

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References

[1] National Eye Institute. "Fact Sheet: Cataracts." nei.nih.gov, 2022.