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Generated: May 28, 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?

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. Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: ribavirin

Drug Master File Entries: see list15
Suppliers / Packagers: see list15
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. Strength Dosage Form
► Subscribe► 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
TABLET;ORAL021511-001Dec 3, 2002ABRXNoNo► Subscribe► Subscribe
Zydus Pharms Usa
CAPSULE;ORAL077224-001Oct 28, 2005ABRXNoNo► Subscribe► Subscribe
Zydus Pharms Usa
TABLET;ORAL077094-001Dec 5, 2005ABRXNoNo► Subscribe► Subscribe
Merck Sharp Dohme
CAPSULE;ORAL020903-002Jul 25, 2001ABRXYesYes6,172,046*PED► SubscribeY► Subscribe
SOLUTION;ORAL021546-001Jul 29, 2003RXYesYes6,524,570*PED► SubscribeY► Subscribe
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