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Ribavirinis the generic ingredient in five branded drugs marketed by Merck Sharp Dohme, Kadmon Pharms Llc, Aurobindo Pharma, Chartwell Rx, Teva, Zydus Pharms Usa, Navinta Llc, Valeant Pharm Intl, Schering, Roche, Beximco Pharms Usa, Heritage Pharma, and Sandoz, and is included in sixteen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
Ribavirin has thirty-three patent family members in twenty-six countries.
There are fifteen drug master file entries for ribavirin. Nine suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for ribavirin
|Drug Master File Entries:||15|
|Suppliers / Packagers:||9|
|Bulk Api Vendors:||93|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for ribavirin|
|DailyMed Link:||ribavirin at DailyMed|
Recent Clinical Trials for ribavirin
Identify potential brand extensions & 505(b)(2) entrants
|Tanta University||Phase 2/Phase 3|
|Mansoura University||Phase 3|
|Bangladesh Medical Research Council (BMRC)||Phase 2/Phase 3|
Generic filers with tentative approvals for RIBAVIRIN
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for ribavirin
|Drug Class||Nucleoside Analog Antiviral |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Zydus Pharms Usa||RIBAVIRIN||ribavirin||TABLET;ORAL||077094-004||Apr 18, 2008||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Valeant Pharm Intl||VIRAZOLE||ribavirin||FOR SOLUTION;INHALATION||018859-001||Dec 31, 1985||AN||RX||Yes||Yes||Start Trial||Start Trial||Start Trial|
|Kadmon Pharms Llc||RIBASPHERE||ribavirin||CAPSULE;ORAL||076203-001||Apr 6, 2004||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Merck Sharp Dohme||REBETOL||ribavirin||CAPSULE;ORAL||020903-001||Jun 3, 1998||Start Trial||Start Trial|
|Merck Sharp Dohme||REBETOL||ribavirin||CAPSULE;ORAL||020903-002||Jul 25, 2001||Start Trial||Start Trial|
|Schering||REBETOL||ribavirin||SOLUTION;ORAL||021546-001||Jul 29, 2003||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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