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VIRAZOLE Drug Profile

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

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

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

Summary for Tradename: VIRAZOLE

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: VIRAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharm Intl
VIRAZOLE
ribavirin
FOR SOLUTION;INHALATION018859-001Dec 31, 1985RXYes6,150,337► subscribe ► subscribe
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Expired Patents for Tradename: VIRAZOLE

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharm Intl
VIRAZOLE
ribavirin
FOR SOLUTION;INHALATION018859-001Dec 31, 19854,211,771► subscribe
Valeant Pharm Intl
VIRAZOLE
ribavirin
FOR SOLUTION;INHALATION018859-001Dec 31, 1985RE29835► subscribe
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Paragraph IV activity 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
5,767,097 Specific modulation of Th1/Th2 cytokine expression by ribavirin in activated T-lymphocytes► 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
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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
Hungary0001186► subscribe
Denmark0879056► subscribe
Poland187439► 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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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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