Ribavirin - Generic Drug Details

What are the generic drug sources for ribavirin and what is the scope of freedom to operate?

Ribavirin is the generic ingredient in five branded drugs marketed by Merck Sharp Dohme, Chartwell Rx, Aurobindo Pharma, Teva, Zydus Pharms Usa, Navinta Llc, Bausch, Schering, Roche, Beximco Pharms Usa, Heritage Pharma Avet, and Sandoz, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for ribavirin. Eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ribavirin

US Patents:	0
Tradenames:	5
Applicants:	12
NDAs:	16
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	1,029
Patent Applications:	5,937
Drug Prices:	Drug price trends for ribavirin
What excipients (inactive ingredients) are in ribavirin?	ribavirin excipients list
DailyMed Link:	ribavirin at DailyMed

See drug prices for ribavirin

Recent Clinical Trials for ribavirin

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 4
Liverpool School of Tropical Medicine	Phase 1/Phase 2
Peking University People's Hospital	Phase 4

See all ribavirin clinical trials

Generic filers with tentative approvals for RIBAVIRIN

Applicant	Application No.	Strength	Dosage Form
		40MG/ML	SOLUTION; 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

Drug Class

Nucleoside Analog Antiviral

Medical Subject Heading (MeSH) Categories for ribavirin

Antimetabolites

Antiviral Agents

Anatomical Therapeutic Chemical (ATC) Classes for ribavirin

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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
Schering	REBETOL	ribavirin	SOLUTION;ORAL	021546-001	Jul 29, 2003		DISCN	Yes	No
Bausch	VIRAZOLE	ribavirin	FOR SOLUTION;INHALATION	018859-001	Dec 31, 1985	AN	RX	Yes	Yes
Teva	RIBAVIRIN	ribavirin	CAPSULE;ORAL	076277-001	Oct 4, 2004		DISCN	No	No
Navinta Llc	RIBAVIRIN	ribavirin	FOR SOLUTION;INHALATION	207366-001	Oct 6, 2016	AN	RX	No	No

Expired US Patents for ribavirin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-002	Jul 25, 2001
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-001	Jun 3, 1998
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-001	Jun 3, 1998
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-001	Jun 3, 1998

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