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Last Updated: July 13, 2020

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Ribavirin - Generic Drug Details

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

Ribavirin is 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.

Drug Prices for ribavirin

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Recent Clinical Trials for ribavirin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Tanta UniversityPhase 2/Phase 3
Mansoura UniversityPhase 3
Bangladesh Medical Research Council (BMRC)Phase 2/Phase 3

See all ribavirin clinical trials

Generic filers with tentative approvals for RIBAVIRIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial40MG/MLSOLUTION; ORAL

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
Medical Subject Heading (MeSH) Categories for ribavirin
Paragraph IV (Patent) Challenges for RIBAVIRIN
Tradename Dosage Ingredient NDA Submissiondate
VIRAZOLE FOR SOLUTION;INHALATION ribavirin 018859 2014-05-22
REBETOL CAPSULE;ORAL ribavirin 020903

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
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

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   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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Serving leading biopharmaceutical companies globally:

Merck
McKinsey
Dow
Johnson and Johnson
Mallinckrodt
Express Scripts

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