Ribavirin Patent Expiration

Ribavirin is Used for treating infections and infestations by modulating cytokine responses in lymphocytes. It was first introduced by Bausch Health Us Llc in its drug Virazole on Dec 31, 1985. Other drugs containing Ribavirin are Rebetol, Copegus. 11 different companies have introduced drugs containing Ribavirin.


Ribavirin Patents

Given below is the list of patents protecting Ribavirin, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Rebetol US6790837

(Pediatric)

Ribavirin syrup formulations Oct 05, 2023

(Expired)

Schering
Rebetol US6790837 Ribavirin syrup formulations Apr 05, 2023

(Expired)

Schering
Rebetol US6172046

(Pediatric)

Combination therapy for eradicating detectable HCV-RNA in patients having chronic Hepatitis C infection Mar 21, 2018

(Expired)

Merck Sharp Dohme
Rebetol US6172046

(Pediatric)

Combination therapy for eradicating detectable HCV-RNA in patients having chronic Hepatitis C infection Mar 21, 2018

(Expired)

Schering
Rebetol US6472373

(Pediatric)

Combination therapy for eradicating detectable HCV-RNA in antiviral treatment naive patients having chronic hepatitis C infection Mar 21, 2018

(Expired)

Merck Sharp Dohme
Rebetol US6472373

(Pediatric)

Combination therapy for eradicating detectable HCV-RNA in antiviral treatment naive patients having chronic hepatitis C infection Mar 21, 2018

(Expired)

Schering
Virazole US6150337 Specific modulation of Th1/Th2 cytokine expression by Ribavirin in activated T-lymphocytes Nov 21, 2017

(Expired)

Bausch
Rebetol US6172046 Combination therapy for eradicating detectable HCV-RNA in patients having chronic Hepatitis C infection Sep 21, 2017

(Expired)

Merck Sharp Dohme
Rebetol US6172046 Combination therapy for eradicating detectable HCV-RNA in patients having chronic Hepatitis C infection Sep 21, 2017

(Expired)

Schering
Rebetol US6472373 Combination therapy for eradicating detectable HCV-RNA in antiviral treatment naive patients having chronic hepatitis C infection Sep 21, 2017

(Expired)

Merck Sharp Dohme
Rebetol US6472373 Combination therapy for eradicating detectable HCV-RNA in antiviral treatment naive patients having chronic hepatitis C infection Sep 21, 2017

(Expired)

Schering
Rebetol US6177074

(Pediatric)

Polyethylene glycol modified interferon therapy May 01, 2017

(Expired)

Merck Sharp Dohme
Rebetol US6177074

(Pediatric)

Polyethylene glycol modified interferon therapy May 01, 2017

(Expired)

Schering
Rebetol US6461605

(Pediatric)

Continuous low-dose cytokine infusion therapy May 01, 2017

(Expired)

Merck Sharp Dohme
Rebetol US6461605

(Pediatric)

Continuous low-dose cytokine infusion therapy May 01, 2017

(Expired)

Schering
Rebetol US6524570

(Pediatric)

Polyethylene glycol modified interferon therapy May 01, 2017

(Expired)

Merck Sharp Dohme
Rebetol US6524570

(Pediatric)

Polyethylene glycol modified interferon therapy May 01, 2017

(Expired)

Schering
Rebetol US6177074 Polyethylene glycol modified interferon therapy Nov 01, 2016

(Expired)

Merck Sharp Dohme
Rebetol US6177074 Polyethylene glycol modified interferon therapy Nov 01, 2016

(Expired)

Schering
Rebetol US6461605 Continuous low-dose cytokine infusion therapy Nov 01, 2016

(Expired)

Merck Sharp Dohme
Rebetol US6461605 Continuous low-dose cytokine infusion therapy Nov 01, 2016

(Expired)

Schering
Rebetol US6524570 Polyethylene glycol modified interferon therapy Nov 01, 2016

(Expired)

Merck Sharp Dohme
Rebetol US6524570 Polyethylene glycol modified interferon therapy Nov 01, 2016

(Expired)

Schering



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Ribavirin's patents.

Given below is the list recent legal activities going on the following patents of Ribavirin.

Activity Date Patent Number
Patent litigations
Correspondence Address Change 26 Aug, 2011 US6790837
Post Issue Communication - Certificate of Correction 05 Mar, 2007 US6790837
Post Issue Communication - Certificate of Correction 26 Oct, 2005 US6461605
Recordation of Patent Grant Mailed 14 Sep, 2004 US6790837
Patent Issue Date Used in PTA Calculation 14 Sep, 2004 US6790837
Issue Notification Mailed 26 Aug, 2004 US6790837
Receipt into Pubs 20 Aug, 2004 US6790837
Dispatch to FDC 19 Aug, 2004 US6790837
Application Is Considered Ready for Issue 19 Aug, 2004 US6790837
Receipt into Pubs 18 Aug, 2004 US6790837


Ribavirin's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Ribavirin:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
A Randomized, Placebo-controlled Trial, to Evaluate the Safety, Immunogenicity and the Optimal Dose of MOPEVAC-Las Vaccine Candidate Against Lassa Fever Institut Pasteur NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1
UMIT-2 - Adaptive Phase IIb Platform Trial to Determine the Efficacy and Safety of Therapeutics for CCHF Liverpool School of Tropical Medicine NA RECRUITING
(Aug 1, 2026)
PHASE2
Treatment of CKD Patients With HCV Tanta University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2, PHASE3
Treatment of Hemorrhagic Fever With Ribavirin U.S. Army Medical Research and Development Command NA SUSPENDED
(Jul 1, 2026)
PHASE2
ARN-75039 Lassa Fever Treatment in West Africa Arisan Therapeutics, Inc. NA SUSPENDED
(Jul 1, 2026)
PHASE2
Study to Assess Efficacy and Safety of Grazoprevir/Elbasvir Associated With Sofosbuvir and Ribavirin in HCV Genotype 1 or 4-infected Patients Who Failed Direct Acting Antivirals (DAA) Bitherapy With Sofosbuvir ANRS, Emerging Infectious Diseases NA COMPLETED
(Jun 1, 2026)
PHASE2
ANRS HC20 Effectiveness of an Optimized Anti HCV PegIFN-alpha2a + Ribavirin on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV ANRS, Emerging Infectious Diseases NA COMPLETED
(Apr 1, 2026)
PHASE2
Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC National Hepatology & Tropical Medicine Research Institute NA COMPLETED
(Apr 1, 2026)
PHASE3


Ribavirin Generic API Manufacturers

Several generic applications have been filed for Ribavirin. The first generic version for Ribavirin was by Chartwell Rx Sciences Llc and was approved on Apr 6, 2004. And the latest generic version is by Chartwell Rx Sciences Llc and was approved on Oct 6, 2016.

Given below is the list of companies who have filed for Ribavirin generic, along with the locations of their manufacturing plants worldwide.