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Profile for Tradename: ORAVIG

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Oravig is a drug marketed by Dara Biosciences and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug.

This drug has twenty patent family members in fourteen countries.

The generic ingredient in ORAVIG is miconazole. There are twenty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the miconazole profile page.

Summary for Tradename: ORAVIG

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list3

Pharmacology for Tradename: ORAVIG

Ingredient-typeAzoles
Drug ClassAzole Antifungal

Clinical Trials for: ORAVIG

Clinical Trial of Hydroquinone Versus Miconazol in Melasma
Status: Recruiting Condition: Melasma

Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients
Status: Completed Condition: HIV Infections

Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
Status: Completed Condition: Bacterial Vaginosis; Candidiasis; Trichomoniasis

Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans
Status: Completed Condition: Healthy

Antifungal Use in Oncohematological Neutropenic Patients
Status: Completed Condition: Invader Fungal Infection

Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis
Status: Completed Condition: Tinea Pedis

Antifungal Locks to Treat Fungal-Related Central Line Infections
Status: Recruiting Condition: Central Line Fungal Infections

An Open-label Study to Evaluate the Effects of Concurrent Administration of Vaginal Antimycotic Medication Miconazole Nitrate on the Pharmacokinetics of Nestorone and Ethinyl Estradiol Delivered by a Contraceptive Vaginal Ring in Normal Ovulating Women
Status: Completed Condition: Antifungal Drug Adverse Reaction

Study to Evaluate the Clinical Outcome in High Risk Patients Who Received Empirical Antifungal Therapy
Status: Active, not recruiting Condition: Antifungal Therapy

Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents
Status: Active, not recruiting Condition: Systemic Fungal Infections

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bioalliance Pharma
ORAVIG
miconazole
TABLET; BUCCAL022404-001Apr 16, 2010RXYes6,916,485<disabled>Y<disabled>
Bioalliance Pharma
ORAVIG
miconazole
TABLET; BUCCAL022404-001Apr 16, 2010RXYes7,651,698<disabled><disabled>
Bioalliance Pharma
ORAVIG
miconazole
TABLET; BUCCAL022404-001Apr 16, 2010RXYes<disabled><disabled>
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International Patent Family for Tradename: ORAVIG

Country Document Number Publication Date
France2827517Jan 24, 2003
European Patent Office1792610Jun 06, 2007
China1547464Nov 17, 2004
Austria373464Oct 15, 2007
Cyprus1108796Apr 09, 2014
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2015 thinkBiotech LLC
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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