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Last Updated: March 19, 2024

VIRAZOLE Drug Patent Profile


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Which patents cover Virazole, and what generic alternatives are available?

Virazole is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in VIRAZOLE is ribavirin. There are fifteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ribavirin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Virazole

A generic version of VIRAZOLE was approved as ribavirin by ZYDUS PHARMS USA on October 28th, 2005.

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Drug patent expirations by year for VIRAZOLE
Drug Prices for VIRAZOLE

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Recent Clinical Trials for VIRAZOLE

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SponsorPhase
U.S. Army Medical Research and Development CommandPhase 2
Bausch Health Americas, Inc.Phase 1
Weill Medical College of Cornell UniversityEarly Phase 1

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Pharmacology for VIRAZOLE
Paragraph IV (Patent) Challenges for VIRAZOLE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VIRAZOLE for Inhalation Solution ribavirin 6 gm/vial 018859 1 2014-05-22

US Patents and Regulatory Information for VIRAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch VIRAZOLE ribavirin FOR SOLUTION;INHALATION 018859-001 Dec 31, 1985 AN RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 VIRAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch VIRAZOLE ribavirin FOR SOLUTION;INHALATION 018859-001 Dec 31, 1985 ⤷  Try a Trial ⤷  Try a Trial
Bausch VIRAZOLE ribavirin FOR SOLUTION;INHALATION 018859-001 Dec 31, 1985 ⤷  Try a Trial ⤷  Try a Trial
Bausch VIRAZOLE ribavirin FOR SOLUTION;INHALATION 018859-001 Dec 31, 1985 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for VIRAZOLE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Merck Sharp and Dohme B.V Rebetol ribavirin EMEA/H/C/000246
Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation.
Withdrawn no no no 1999-05-06
Teva B.V. Ribavirin Teva Pharma B.V. ribavirin EMEA/H/C/001064
Ribavirin Teva Pharma B.V. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1).Ribavirin Teva Pharma B.V. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) notpreviously treated and without liver decompensation (see sections 4.2, 4.4 and 5.1).
Withdrawn yes no no 2009-07-01
Teva B.V. Ribavirin Teva ribavirin EMEA/H/C/001018
Ribavirin Teva is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. Ribavirin monotherapy must not be used.There is no safety or efficacy information on the use of Ribavirin with other forms of interferon (i.e. not alfa-2b).Naïve patients Adult patients Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid HCV-RNA.Paediatric patients (children 3 years of age and older and adolescents) Ribavirin Teva is indicated, in a combination regimen with interferon alfa­2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV-RNA.When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis.Previous treatment failure patientsAdult patients Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.
Withdrawn yes no no 2009-03-31
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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