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Serving leading biopharmaceutical companies globally:

Medtronic
Julphar
Argus Health
Moodys
Merck
Fish and Richardson
Daiichi Sankyo
Healthtrust
Harvard Business School
Baxter

Generated: November 20, 2017

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Ribavirin - Generic Drug Details

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What are the generic sources for ribavirin and what is the scope of ribavirin patent protection?

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 seven 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 two patent family members in twenty-six countries.

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

Pharmacology for ribavirin

Medical Subject Heading (MeSH) Categories for ribavirin

Tentative approvals for RIBAVIRIN

Applicant Application No. Strength Dosage Form
u► Subscribe40MG/MLSOLUTION; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering
REBETOL
ribavirin
SOLUTION;ORAL021546-001Jul 29, 2003RXYesYes► Subscribe► SubscribeY► Subscribe
Sandoz Inc
RIBAVIRIN
ribavirin
TABLET;ORAL202546-002Aug 12, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
REBETOL
ribavirin
CAPSULE;ORAL020903-001Jun 3, 1998DISCNNoNo► Subscribe► SubscribeY► Subscribe
Schering
REBETOL
ribavirin
SOLUTION;ORAL021546-001Jul 29, 2003RXYesYes► Subscribe► SubscribeY► Subscribe
Aurobindo Pharma
RIBAVARIN
ribavirin
CAPSULE;ORAL079117-001Sep 17, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
REBETOL
ribavirin
CAPSULE;ORAL020903-001Jun 3, 1998DISCNNoNo► Subscribe► SubscribeY► Subscribe
Teva
RIBAVIRIN
ribavirin
CAPSULE;ORAL076277-001Oct 4, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa
RIBAVIRIN
ribavirin
TABLET;ORAL077094-004Apr 18, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa
RIBAVIRIN
ribavirin
TABLET;ORAL077094-003Mar 16, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Valeant Pharm Intl
VIRAZOLE
ribavirin
FOR SOLUTION;INHALATION018859-001Dec 31, 1985ANRXYesYes► Subscribe► 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;ORAL020903-002Jul 25, 2001► Subscribe► Subscribe
Schering
REBETOL
ribavirin
SOLUTION;ORAL021546-001Jul 29, 2003► Subscribe► Subscribe
Merck Sharp Dohme
REBETOL
ribavirin
CAPSULE;ORAL020903-002Jul 25, 2001► Subscribe► Subscribe
Valeant Pharm Intl
VIRAZOLE
ribavirin
FOR SOLUTION;INHALATION018859-001Dec 31, 1985► Subscribe► Subscribe
Merck Sharp Dohme
REBETOL
ribavirin
CAPSULE;ORAL020903-001Jun 3, 1998► Subscribe► Subscribe
Merck Sharp Dohme
REBETOL
ribavirin
CAPSULE;ORAL020903-001Jun 3, 1998► Subscribe► Subscribe
Merck Sharp Dohme
REBETOL
ribavirin
CAPSULE;ORAL020903-001Jun 3, 1998► Subscribe► Subscribe
Valeant Pharm Intl
VIRAZOLE
ribavirin
FOR SOLUTION;INHALATION018859-001Dec 31, 1985► Subscribe► Subscribe
Merck Sharp Dohme
REBETOL
ribavirin
CAPSULE;ORAL020903-002Jul 25, 2001► Subscribe► Subscribe
Merck Sharp Dohme
REBETOL
ribavirin
CAPSULE;ORAL020903-002Jul 25, 2001► Subscribe► 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
6,455,690 L-8-oxo-7-propyl-7,8-dihydro-(9H)-guanosine► Subscribe
6,479,463 Purine L-nucleosides, analogs and uses thereof► Subscribe
6,509,320 Purine L-nucleosides, analogs and uses thereof► Subscribe
6,423,695 Cytokine related treatments of disease► 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 Ingredient: ribavirin

Country Document Number Estimated Expiration
Norway20004329► Subscribe
Norway20004327► Subscribe
China1190198► Subscribe
Slovakia48199► Subscribe
Hungary0002453► Subscribe
New Zealand330784► Subscribe
Poland332694► Subscribe
Austria216886► Subscribe
Slovakia100498► Subscribe
World Intellectual Property Organization (WIPO)9830223► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Johnson and Johnson
Cerilliant
Queensland Health
Baxter
Healthtrust
Fish and Richardson
Deloitte
Farmers Insurance
US Department of Justice

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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