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-four 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:	1,698
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	5,607,942*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
Canada	2774207
European Patent Office	1117406
Hong Kong	1150756
Mexico	2010012933	COMPOSICIONES FARMACEUTICAS QUE CONTIENEN UNA DROGA ANTIBIOTICA DE FLUOROQUINOLONA. (PHARMACEUTICAL COMPOSITIONS CONTAINING A FLUOROQUINOLONE ANTIBIOTIC DRUG.)

Supplementary Protection Certificates for MOXEZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for Moxeza

Introduction

Moxeza, a topical fluoroquinolone antibiotic, has been a significant player in the treatment of bacterial conjunctivitis. However, the market dynamics and financial trajectory of Moxeza have been influenced by several key factors, including patent expiries, generic competition, and the broader trends in the ophthalmic drug market.

Market Segmentation and Dominance

Moxeza falls under the fluoroquinolone class of drugs, which has historically dominated the market for bacterial conjunctivitis treatments. Fluoroquinolones, including Moxeza, have been preferred due to their broad-spectrum antibacterial activity and ease of use[1][4].

Patent Expiry and Generic Competition

One of the most critical factors affecting Moxeza's market dynamics is the expiry of its patent. The loss of patent protection has led to the entry of generic versions of the drug, which offer similar efficacy at a lower cost. This shift has significantly impacted the demand for branded drugs like Moxeza, resulting in a decline in revenue for the original manufacturers[1][4].

Impact on Revenue

The patent expiry of Moxeza, along with other blockbuster fluoroquinolones such as Vigamox and Zymaxid, has led to a substantial decline in the market opportunity for these drugs. For instance, the U.S. market for bacterial conjunctivitis drugs, which was valued at $473.3 million in 2013, is projected to decline to $439.8 million by 2024. This decline is largely attributed to the genericization of these drugs[4].

Market Trends and Challenges

The bacterial conjunctivitis drugs market is facing several challenges that further complicate the financial trajectory of Moxeza. The rising prevalence of multi-drug resistant organisms (MDROs) poses a significant challenge, as existing antibiotics, including fluoroquinolones, are becoming less effective. This has prompted researchers to seek new and more efficient treatments, but the absence of effective medications in the near future is likely to hamper market growth[4].

Generic Encroachment

The encroachment by generic variations of fluoroquinolones is another major factor affecting Moxeza's market share. Generic drugs, with their lower prices and similar efficacy, have increased sales volume but at the cost of revenue for branded drugs. This trend is expected to continue, further eroding the market share of Moxeza and other branded fluoroquinolones[4].

Strategic Alliances and Product Development

To mitigate the impact of patent expiries and generic competition, pharmaceutical companies are exploring strategic alliances and product development partnerships. These collaborations, particularly with small biotech research organizations, can help in developing new treatments and reducing the financial burden on larger pharmaceutical companies. However, these strategies are still in the early stages and may not immediately offset the losses incurred by the expiry of Moxeza's patent[4].

Financial Performance of Pharmaceutical Companies

The financial performance of companies that have marketed Moxeza reflects the broader market trends. For example, the loss of patent protection for key products, including ophthalmic drugs like Moxeza, has impacted the revenue and market position of these companies. Despite this, some companies have managed to maintain growth through diversification and the launch of new products in other therapeutic areas[2][3].

Regional Impact

The impact of Moxeza's patent expiry is not uniform across all regions. In the U.S., the market for bacterial conjunctivitis drugs has been particularly affected, with a significant decline in revenue due to generic competition. However, in other regions, the impact may be less severe, depending on local regulatory environments and market dynamics[4].

Future Outlook

The future outlook for Moxeza and similar fluoroquinolones remains challenging. The ongoing trend of genericization and the need for new treatments to address MDROs suggest that the market will continue to evolve. Pharmaceutical companies will need to adapt through innovative product development, strategic partnerships, and diversification to maintain their market presence[4].

Key Takeaways

• Patent Expiry: The loss of patent protection for Moxeza has led to significant generic competition.
• Revenue Decline: The market opportunity for Moxeza and other fluoroquinolones is declining due to genericization.
• MDROs: The rising prevalence of multi-drug resistant organisms poses a challenge for the treatment of bacterial conjunctivitis.
• Strategic Alliances: Pharmaceutical companies are exploring partnerships to develop new treatments and reduce financial burdens.
• Regional Impact: The impact of patent expiry varies by region, with the U.S. market being particularly affected.

FAQs

What is the primary reason for the decline in Moxeza's market share?

The primary reason for the decline in Moxeza's market share is the expiry of its patent, leading to the entry of generic versions of the drug.

How has the rise of MDROs affected the bacterial conjunctivitis drugs market?

The rise of MDROs has created a significant challenge for the treatment of bacterial conjunctivitis, as existing antibiotics, including fluoroquinolones like Moxeza, are becoming less effective.

What strategies are pharmaceutical companies adopting to mitigate the impact of patent expiries?

Pharmaceutical companies are adopting strategies such as product development partnerships and strategic alliances with small biotech research organizations to develop new treatments and reduce financial burdens.

How has the U.S. market for bacterial conjunctivitis drugs been affected by generic competition?

The U.S. market for bacterial conjunctivitis drugs has been significantly affected by generic competition, leading to a decline in revenue from $473.3 million in 2013 to a projected $439.8 million by 2024.

What is the future outlook for Moxeza and similar fluoroquinolones?

The future outlook for Moxeza and similar fluoroquinolones remains challenging due to ongoing genericization and the need for new treatments to address MDROs. Pharmaceutical companies will need to adapt through innovative product development and strategic partnerships.

Sources

1. Global Conjunctivitis Drugs Market 2018-2024: Loss of Moxeza, Besivance, Vigamox, and Zymaxid has Hampered the Growth of the Market[1].
2. AstraZeneca FY and Q4 2023 results: Strong growth and pipeline momentum with three new medicines approved since the third quarter[2].
3. Novartis US SECURITIES & EXCHANGE COMMISSION FORM 20-F 2012: Including additional analyses of existing clinical data or unexpected new clinical data[3].
4. US Bacterial Conjunctivitis Drugs Market Trends and Insight 2024: The U.S. market for bacterial conjunctivitis drugs has been declining sharply over the last few years[4].