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Serving leading biopharmaceutical companies globally:

Chubb
Boehringer Ingelheim
Teva
Harvard Business School
Accenture
Novartis
AstraZeneca
Cantor Fitzgerald
US Department of Justice
Deloitte

Generated: October 17, 2017

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VIRAZOLE Drug Profile

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What is the patent landscape for Virazole, and when can generic versions of Virazole launch?

Virazole is a drug marketed by Valeant Pharm Intl and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has one hundred and two patent family members in twenty-six countries.

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 Tradename: VIRAZOLE

US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list64
Patent Applications: see list8,113
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:VIRAZOLE at DailyMed

Pharmacology for Tradename: VIRAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharm Intl
VIRAZOLE
ribavirin
FOR SOLUTION;INHALATION018859-001Dec 31, 1985ANRXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Patents for Tradename: VIRAZOLE

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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Paragraph IV (Patent) Challenges for VIRAZOLE

Drugname Dosage Strength RLD Submissiondate
ribavirinFor Inhalation Solution6 gm/vialVirazole5/22/2014

Non-Orange Book Patents for Tradename: VIRAZOLE

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
6,479,463 Purine L-nucleosides, analogs and uses thereof► Subscribe
5,767,097 Specific modulation of Th1/Th2 cytokine expression by ribavirin in activated T-lymphocytes► Subscribe
6,423,695 Cytokine related treatments of disease► Subscribe
6,455,690 L-8-oxo-7-propyl-7,8-dihydro-(9H)-guanosine► Subscribe
6,509,320 Purine L-nucleosides, analogs and uses thereof► Subscribe
6,063,772 Specific modulation of Th1/Th2 cytokine expression by ribavirin in activated T-lymphocytes► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: VIRAZOLE

Country Document Number Estimated Expiration
China1209747► Subscribe
Germany69729887► Subscribe
Poland336579► Subscribe
Slovakia100498► Subscribe
Hong Kong1021738► Subscribe
New Zealand505553► Subscribe
Japan2004035537► Subscribe
Japan2008133293► Subscribe
Czech Republic9901267► Subscribe
European Patent Office1103559► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Department of Justice
Covington
Chubb
Fish and Richardson
Farmers Insurance
Johnson and Johnson
Novartis
Healthtrust
Dow

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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