VIGAMOX Drug Patent Profile

When do Vigamox patents expire, and when can generic versions of Vigamox launch?

Vigamox is a drug marketed by Harrow Eye and is included in one NDA.

The generic ingredient in VIGAMOX 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 Vigamox

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

Summary for VIGAMOX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	33
Patent Applications:	1,698
Drug Prices:	Drug price information for VIGAMOX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIGAMOX
What excipients (inactive ingredients) are in VIGAMOX?	VIGAMOX excipients list
DailyMed Link:	VIGAMOX at DailyMed

See drug prices for VIGAMOX

See drug sales revenues for VIGAMOX

Recent Clinical Trials for VIGAMOX

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

Sponsor	Phase
Kafrelsheikh University	Phase 4
Benha University	Phase 1
University of Campinas, Brazil	Phase 2

See all VIGAMOX clinical trials

Pharmacology for VIGAMOX

Drug Class

Fluoroquinolone Antibacterial

Paragraph IV (Patent) Challenges for VIGAMOX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIGAMOX	Ophthalmic Solution/Drops	moxifloxacin hydrochloride	0.5%	021598	1	2005-12-22

US Patents and Regulatory Information for VIGAMOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003	AT1	RX	Yes	Yes

Expired US Patents for VIGAMOX

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	4,990,517*PED
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003	7,671,070*PED
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003	5,607,942*PED
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003	6,716,830*PED
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003	5,849,752*PED

International Patents for VIGAMOX

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

Country	Patent Number	Title	Estimated Expiration
Brazil	9605968
China	1061348
European Patent Office	0780390	Modification cristalline du CDCH, procédé pour sa préparation et compositions pharmaceutiques la contenant (Crystalline modification of CDCH, process for its preparation and pharmaceutical compositions containing it)
Malaysia	117492	NEW CRYSTAL MODIFICATION OF CDCH, A PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL FORMULATIONS COMPRISING THIS MODIFICATION
Norway	306725
South Africa	200101752	Methods of treating or preventing ophthalmi infections with moxifloxacin.
Yugoslavia	49485

Supplementary Protection Certificates for VIGAMOX

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
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	300111	Netherlands
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
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 VIGAMOX

Introduction to VIGAMOX

VIGAMOX, also known as moxifloxacin hydrochloride solution, is a fluoroquinolone antibiotic eye drop used primarily for the treatment of bacterial conjunctivitis caused by susceptible strains. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Acquisition and Commercialization

In January 2023, Harrow Inc. acquired the U.S. commercial rights to VIGAMOX, marking it as the fourth FDA-approved ophthalmic product from this acquisition to become commercially available under the Harrow name[3].

Market Position and Acceptance

VIGAMOX is well-regarded by U.S. eyecare professionals for its exceptional record of safety and efficacy. It is often considered the preferred broad-spectrum topical antibiotic for treating bacterial conjunctivitis and other common bacterial-based infections. This strong market acceptance is a significant factor in its commercial success[3].

Distribution and Sales Strategy

Harrow has implemented various strategies to enhance market access and sales of VIGAMOX. These include national sales detailing, inventory management, and leveraging a wholesaler distribution system that encompasses major distributors like McKesson and AmerisourceBergen. Product orders can be made directly through Harrow’s dedicated customer service ordering partner, Cardinal’s Cordlogistics[3].

Financial Performance

The financial performance of VIGAMOX is closely tied to Harrow Inc.'s overall financial health. Here are some key financial highlights:

Revenue Contribution

In the third quarter of 2024, Harrow Inc. reported revenues of $49.3 million, a 44% increase over the prior year’s third quarter. While the specific revenue contribution of VIGAMOX is not detailed, the acquisition and commercialization of this product are part of Harrow's broader strategy to increase revenue[2].

Price Reduction

Harrow Inc. recently announced a price reduction for VIGAMOX and another product, MAXIDEX®, which could impact revenue but is expected to enhance market competitiveness and patient access[2].

Future Projections

Harrow Inc. remains confident about its financial outlook, with expectations that revenues in the second half of 2024 will significantly outpace those in the first half. This optimism is partly due to the relaunch of other products, including TRIESENCE®, and the anticipated strong performance of VIGAMOX[2].

Market Growth and Trends

The ophthalmology drugs market, within which VIGAMOX operates, is experiencing significant growth. Here are some key trends and projections:

Global Market Growth

The global ophthalmology drugs market is expected to grow from $50.62 billion in 2021 to $127.15 billion in 2026 at a CAGR of 22.7%. This growth is driven by the increasing prevalence of eye-related disorders and the recovery from COVID-19 impacts[1].

U.S. Market

In the U.S., the ophthalmic drugs market was estimated at $15.53 billion in 2023 and is anticipated to grow at a CAGR of 7.4% from 2024 to 2030. The aging population and rising prevalence of eye disorders are key drivers of this growth[4].

Competitive Landscape

VIGAMOX operates in a competitive market with several major players. Here are some of the top competitors:

Key Competitors

Companies like Novartis AG, F. Hoffmann-La Roche Ltd, Allergan Plc, Valeant Pharmaceuticals Intl Inc, and Bayer AG are significant players in the ophthalmology drugs market. Harrow Inc., with its acquisition of VIGAMOX, is positioning itself to compete effectively in this space[1].

Regulatory Environment

The pharmaceutical industry, including ophthalmic drugs, is heavily regulated. Here are some key points:

FDA Approvals

VIGAMOX has completed the NDA transfer process and is FDA-approved, which is crucial for its commercial success. Regulatory approvals and compliance are ongoing challenges and opportunities for Harrow Inc.[3].

Future Regulatory Impact

Harrow Inc. is also evaluating the potential impact of the Inflation Reduction Act (IRA) and pharmaceutical regulatory policies on its financial performance and product launches, including VIGAMOX[2].

Conclusion

VIGAMOX, with its strong market acceptance and strategic commercialization by Harrow Inc., is poised for continued growth within the expanding ophthalmology drugs market. The financial trajectory of VIGAMOX is closely tied to Harrow's overall performance, which is expected to be positive given the company's strategic initiatives and market trends.

Key Takeaways

• Market Acceptance: VIGAMOX is well-regarded by eyecare professionals for its safety and efficacy.
• Commercialization: Harrow Inc. has implemented robust sales and distribution strategies.
• Financial Performance: Part of Harrow's revenue growth, with future projections indicating significant increases.
• Market Growth: The ophthalmology drugs market is growing rapidly globally and in the U.S.
• Competitive Landscape: Operates in a competitive market with major pharmaceutical companies.
• Regulatory Environment: FDA-approved and subject to ongoing regulatory evaluations.

FAQs

Q: What is VIGAMOX used for? A: VIGAMOX is used for the treatment of bacterial conjunctivitis caused by susceptible strains.

Q: Who acquired the U.S. commercial rights to VIGAMOX? A: Harrow Inc. acquired the U.S. commercial rights to VIGAMOX in January 2023.

Q: How is VIGAMOX distributed? A: VIGAMOX is distributed through a wholesaler system that includes McKesson and AmerisourceBergen, with orders managed by Cardinal’s Cordlogistics.

Q: What are the future financial projections for Harrow Inc.? A: Harrow Inc. expects revenues in the second half of 2024 to significantly outpace those in the first half, with a confident outlook for 2025.

Q: What are the key drivers of the ophthalmology drugs market growth? A: The increasing prevalence of eye-related disorders and the recovery from COVID-19 impacts are key drivers of the market growth.

Sources

1. The Business Research Company: Ophthalmology Drugs Market Size 2022 And Growth Analysis
2. Harrow Inc.: Form 8-K for Harrow INC filed 11/14/2024
3. Harrow Inc.: Harrow Launches VIGAMOX® in the US - July 31, 2023
4. Grand View Research: U.S. Ophthalmic Drugs Market Size | Industry Report, 2030