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Last Updated: November 21, 2024

RIBAVIRIN Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Ribavirin

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

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Summary for RIBAVIRIN
Drug patent expirations by year for RIBAVIRIN
Drug Prices for RIBAVIRIN

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Recent Clinical Trials for RIBAVIRIN

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SponsorPhase
National Cancer Institute (NCI)Phase 4
Liverpool School of Tropical MedicinePhase 1/Phase 2
Peking University People's HospitalPhase 4

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Pharmacology for RIBAVIRIN
Medical Subject Heading (MeSH) Categories for RIBAVIRIN
Paragraph IV (Patent) Challenges for RIBAVIRIN
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 RIBAVIRIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma RIBAVIRIN ribavirin CAPSULE;ORAL 079117-001 Sep 17, 2009 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms Usa RIBAVIRIN ribavirin TABLET;ORAL 077094-004 Apr 18, 2008 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Beximco Pharms Usa RIBAVIRIN ribavirin TABLET;ORAL 202546-001 Aug 12, 2014 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms Usa RIBAVIRIN ribavirin CAPSULE;ORAL 077224-001 Oct 28, 2005 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for RIBAVIRIN

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
Mylan S.A.S Ribavirin Mylan (previously Ribavirin Three Rivers) ribavirin EMEA/H/C/001185
Ribavirin Mylan is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (three years of age and older) and adolescents). 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).Please refer also to the interferon alfa-2b summary of product characteristics (SmPC) for prescribing information particular to that product.Naïve patientsAdult patientsRibavirin Mylan 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 serum hepatitis-C-virus (HCV) RNA.Children and adolescentsRibavirin Mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents three 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 serum HCV RNA. When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case-by-case basis (see section 4.4).Previously treatment-failure patientsAdult patientsRibavirin Mylan 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 2010-06-10
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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