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Profile for Tradename: VIGAMOX

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Vigamox is a drug marketed by Alcon Pharms Ltd and is included in one NDA. It is available from four suppliers. There are three patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in VIGAMOX is moxifloxacin hydrochloride. There are seventeen drug master file entries for this compound. Eleven suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.

Summary for Tradename: VIGAMOX

Patents:3
Applicants:1
NDAs:1
Suppliers: see list4

Pharmacology for Tradename: VIGAMOX

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial

Clinical Trials for: VIGAMOX

Food and Insulin Effect on QT/QTC Interval of ECG
Status: Completed Condition: Effects of Different Meals on the QT/QTc Interval; Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use; C-Peptide Effects on the QT/QTc Interval; Moxifloxacin ECG Profile in Fed and Fasted State; Japanese vs. Caucasian TQT Comparison

Effect on Wound Healing of Vigamox Versus Cravit
Status: Completed Condition: Cataract Extraction

Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification
Status: Recruiting Condition: Cataracts

Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers
Status: Completed Condition: Bacterial Infections; Eye Infections

Bioequivalence of Eye Drops and Spray Administration of Vigamox
Status: Completed Condition: Cataract

Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery
Status: Completed Condition: Bacterial Infections; Eye Infections; Cataract Extraction

QT Intervals Study to Compare the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo
Status: Completed Condition: Healthy

Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection.
Status: Completed Condition: Side-effect of Antibiotic

To Investigate the Effect of Intravenous Ondansetron on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects
Status: Completed Condition: Nausea and Vomiting, Chemotherapy-Induced; Nausea and Vomiting, Postoperative

Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess
Status: Recruiting Condition: Liver Abscess

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alcon Pharms Ltd
VIGAMOX
moxifloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC021598-001Apr 15, 2003RXYes5,607,942*PED<disabled><disabled>
Alcon Pharms Ltd
VIGAMOX
moxifloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC021598-001Apr 15, 2003RXYes7,671,070*PED<disabled>Y<disabled>
Alcon Pharms Ltd
VIGAMOX
moxifloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC021598-001Apr 15, 2003RXYes6,716,830*PED<disabled>Y<disabled>
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Paragraph IV activity for: VIGAMOX

Drugname Dosage Strength RLD Submissiondate
moxifloxacin hydrochlorideOphthalmic0.50%Vigamox12/22/2005

Non-Orange Book Patents for Tradename: VIGAMOX

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
4,990,517 7-(1-pyrrolidinyl)-3-quinolone- and -naphthyridonecarboxylic acid derivatives as antibacterial agents and feed additives<disabled in preview>
5,416,096 7-(1-pyrrolidinyl)-3-quinolone carboxylic acid derivatives as antibacterial agents and feed additives<disabled in preview>
5,059,597 7-(4-oxa or 4-thia-2,7-diazabicyclo[3.3.0]oct-2-en-3-yl)-3-quinolone-and-naphthyrido ne-carboxylic acid derivatives as antibacterial agents and feed additives<disabled in preview>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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