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Serving leading biopharmaceutical companies globally:

Deloitte
QuintilesIMS
Chubb
Baxter
US Department of Justice
US Army
Boehringer Ingelheim
Queensland Health
Cerilliant
Johnson and Johnson

Generated: January 23, 2018

DrugPatentWatch Database Preview

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, Aurobindo Pharma, Sandoz, Teva, Zydus Pharms Usa, Navinta Llc, Valeant Pharm Intl, Schering, Roche, and Sandoz Inc, 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
➤ Subscribe➤ Subscribe40MG/MLSOLUTION; ORAL

US Patents and Regulatory Information for ribavirin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz Inc RIBAVIRIN ribavirin TABLET;ORAL 202546-002 Aug 12, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Schering REBETOL ribavirin SOLUTION;ORAL 021546-001 Jul 29, 2003 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 DISCN No No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sandoz Inc RIBAVIRIN ribavirin TABLET;ORAL 202546-003 Aug 12, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Kadmon Pharms Llc RIBAVIRIN ribavirin TABLET;ORAL 077456-001 Dec 5, 2005 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 DISCN No No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-002 Jul 25, 2001 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-002 Jul 25, 2001 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Schering REBETOL ribavirin SOLUTION;ORAL 021546-001 Jul 29, 2003 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Teva RIBAVIRIN ribavirin CAPSULE;ORAL 076277-001 Oct 4, 2004 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ribavirin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 ➤ Subscribe ➤ Subscribe
Valeant Pharm Intl VIRAZOLE ribavirin FOR SOLUTION;INHALATION 018859-001 Dec 31, 1985 ➤ Subscribe ➤ Subscribe
Schering REBETOL ribavirin SOLUTION;ORAL 021546-001 Jul 29, 2003 ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-002 Jul 25, 2001 ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-002 Jul 25, 2001 ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-002 Jul 25, 2001 ➤ Subscribe ➤ Subscribe
Schering REBETOL ribavirin SOLUTION;ORAL 021546-001 Jul 29, 2003 ➤ Subscribe ➤ Subscribe
Valeant Pharm Intl VIRAZOLE ribavirin FOR SOLUTION;INHALATION 018859-001 Dec 31, 1985 ➤ Subscribe ➤ Subscribe
Schering REBETOL ribavirin SOLUTION;ORAL 021546-001 Jul 29, 2003 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
6,479,463 Purine L-nucleosides, analogs and uses thereof ➤ 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
6,423,695 Cytokine related treatments of disease ➤ Subscribe
6,455,690 L-8-oxo-7-propyl-7,8-dihydro-(9H)-guanosine ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for ribavirin

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Serving leading biopharmaceutical companies globally:

Healthtrust
QuintilesIMS
Queensland Health
Teva
Cerilliant
Merck
Farmers Insurance
Johnson and Johnson
Citi

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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