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Last Updated: September 25, 2022

REBETOL Drug Patent Profile


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Which patents cover Rebetol, and when can generic versions of Rebetol launch?

Rebetol is a drug marketed by Merck Sharp Dohme and Schering and is included in two NDAs. There is one patent protecting this drug.

This drug has thirty-three patent family members in twenty-six countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Rebetol

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

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

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Recent Clinical Trials for REBETOL

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

SponsorPhase
Tanta UniversityPhase 2/Phase 3
Memorial Sloan Kettering Cancer CenterEarly Phase 1
Weill Medical College of Cornell UniversityEarly Phase 1

See all REBETOL clinical trials

Pharmacology for REBETOL

US Patents and Regulatory Information for REBETOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-002 Jul 25, 2001 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Schering REBETOL ribavirin SOLUTION;ORAL 021546-001 Jul 29, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 REBETOL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-002 Jul 25, 2001 See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 See Plans and Pricing See Plans and Pricing
Schering REBETOL ribavirin SOLUTION;ORAL 021546-001 Jul 29, 2003 See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-002 Jul 25, 2001 See Plans and Pricing See Plans and Pricing
Schering REBETOL ribavirin SOLUTION;ORAL 021546-001 Jul 29, 2003 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for REBETOL

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.
Authorised 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
BioPartners GmbH Ribavirin BioPartners ribavirin EMEA/H/C/001184
Ribavirin BioPartners is indicated for the treatment of chronic hepatitis-C-virus (HCV) infection in adults, children three 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 patientsAdult patientsRibavirin BioPartners 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) (see section 4.4)Children three years of age and older and adolescentsRibavirin BioPartners is intended for use, in a combination regimen with interferon alfa-2b, for the treatment of children three years of age and older and adolescents, 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 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).Previous-treatment-failure patientsAdult patientsRibavirin BioPartners 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 alfa monotherapy but who have subsequently relapsed (see section 5.1).
Withdrawn yes no no 2010-04-06
Schering-Plough Europe Cotronak ribavirin EMEA/H/C/000247
Cotronak is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b. Cotronak monotherapy must not be used.There is no safety or efficacy information on the use of Cotronak with other forms of interferon (i.e., not alfa-2b).Please refer also to the peginterferon alfa-2b or interferon alfa-2b Summary of Product Characteristics (SPC) for prescribing information particular to that product.
Withdrawn no no no 1999-05-07
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for REBETOL

See the table below for patents covering REBETOL around the world.

Country Patent Number Title Estimated Expiration
South Africa 7401610 See Plans and Pricing
United Kingdom 1427304 See Plans and Pricing
Brazil 0213536 See Plans and Pricing
Iceland 913 See Plans and Pricing
Portugal 72322 PROCESS FOR PREPARATION OF RECOMBINANT DNA MOLECULES AND OF POLIPEPTIDES SIMILAR TO HUMAN INTERFERON See Plans and Pricing
Yugoslavia 61598 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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