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Ribavirin - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ribavirin?

Ribavirin is the generic ingredient in six branded drugs marketed by Merck Sharp Dohme, Kadmon Pharms Llc, Roche, Aurobindo Pharma, Zydus Pharms Usa, Sandoz, Schering, Sandoz Inc, Teva, Valeant Pharm Intl, and Navinta Llc, and is included in sixteen NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are fifteen drug master file entries for ribavirin. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: ribavirin

Tradenames:6
Patents:8
Applicants:11
NDAs:16
Drug Master File Entries: see list15
Suppliers / Packagers: see list13
Bulk Api Vendors: see list63
Clinical Trials: see list490
Patent Applications: see list8,630
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ribavirin at DailyMed

Pharmacology for Ingredient: ribavirin

Tentative approvals for RIBAVIRIN

Applicant Application No. Form Dosage
► Subscribe► SubscribeSOLUTION; ORAL40MG/ML
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz Inc
RIBAVIRIN
ribavirin
TABLET;ORAL202546-001Aug 12, 2014RXNoNo► Subscribe► Subscribe
Roche
COPEGUS
ribavirin
TABLET;ORAL021511-002Jun 21, 2005DISCNNoNo► Subscribe► Subscribe
Zydus Pharms Usa
RIBAVIRIN
ribavirin
TABLET;ORAL077094-004Apr 18, 2008RXNoNo► Subscribe► Subscribe
Roche
COPEGUS
ribavirin
TABLET;ORAL021511-001Dec 3, 2002RXNoNo► Subscribe► Subscribe
Teva
RIBAVIRIN
ribavirin
CAPSULE;ORAL076277-001Oct 4, 2004RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ribavirin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
REBETOL
ribavirin
CAPSULE;ORAL020903-001Jun 3, 19984,211,771► Subscribe
Valeant Pharm Intl
VIRAZOLE
ribavirin
FOR SOLUTION;INHALATION018859-001Dec 31, 19854,211,771► Subscribe
Merck Sharp Dohme
REBETOL
ribavirin
CAPSULE;ORAL020903-002Jul 25, 20015,767,097*PED► Subscribe
Merck Sharp Dohme
REBETOL
ribavirin
CAPSULE;ORAL020903-002Jul 25, 20016,063,772*PED► Subscribe
Merck Sharp Dohme
REBETOL
ribavirin
CAPSULE;ORAL020903-001Jun 3, 19984,530,901► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ribavirin

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
6,509,320 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
6,479,463 Purine L-nucleosides, analogs and uses thereof► Subscribe
6,455,690 L-8-oxo-7-propyl-7,8-dihydro-(9H)-guanosine► 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 Ingredient: ribavirin

Country Document Number Estimated Expiration
Australia736075► Subscribe
Canada2266889► Subscribe
Poland336579► Subscribe
Japan2002080490► Subscribe
China1286258► 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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