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Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018859

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NDA 018859 describes VIRAZOLE, which is a drug marketed by Valeant Pharm Intl and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the VIRAZOLE profile page.

The generic ingredient in VIRAZOLE is ribavirin. There are fifteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ribavirin profile page.

Summary for NDA: 018859

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 018859

Ingredient-typeNucleoside Analog

Suppliers and Packaging for NDA: 018859

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIRAZOLE
ribavirin
FOR SOLUTION;INHALATION 018859 NDA Valeant Pharmaceuticals North America LLC 0187-0007 0187-0007-14 4 VIAL, GLASS in 1 CARTON (0187-0007-14) > 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS
VIRAZOLE
ribavirin
FOR SOLUTION;INHALATION 018859 NDA Oceanside Pharmaceuticals 68682-019 68682-019-06 4 VIAL, GLASS in 1 CARTON (68682-019-06) > 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;INHALATIONStrength6GM/VIAL
Approval Date:Dec 31, 1985TE:ANRLD:Yes
Patent:► SubscribePatent Expiration:Nov 21, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF RIBAVIRIN TO INCREASE TYPE 1 CYTOKINE RESPONSE AND SUPPRESS TYPE 2 CYTOKINE RESP0NSE TO LYMPHOCYTES, INCLUDING METHODS THAT TAKE ADVANTAGE OF SUCH MODULATION TO TREAT INFECTIONS AND INFESTATIONS

Expired Orange Book Patents for NDA: 018859

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharm Intl
VIRAZOLE
ribavirin
FOR SOLUTION;INHALATION018859-001Dec 31, 1985► Subscribe► Subscribe
Valeant Pharm Intl
VIRAZOLE
ribavirin
FOR SOLUTION;INHALATION018859-001Dec 31, 1985► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Accenture
US Army
Dow
Moodys
Cantor Fitzgerald
Daiichi Sankyo
Colorcon
Fuji
McKesson
Argus Health

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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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