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. 12 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.

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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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 Navinta 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.


1. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 1 generic for Ribavirin. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

(reference standard)

capsule Prescription ORAL AB Sep 17, 2009


Manufacturing Plant Locations
New

Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd
Sangareddy Aurobindo Pharma Limited
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





2. BEXIMCO PHARMS USA

Beximco Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Ribavirin. Given below are the details of the strengths of this generic introduced by Beximco Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Discontinued ORAL N/A Aug 12, 2014
400MG

tablet Discontinued ORAL N/A Aug 12, 2014
500MG

tablet Discontinued ORAL N/A Aug 12, 2014
600MG

tablet Discontinued ORAL N/A Aug 12, 2014





3. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 3 different strengths of generic version for Ribavirin. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Discontinued ORAL N/A Dec 5, 2005
600MG

tablet Discontinued ORAL N/A Dec 5, 2005
400MG

tablet Discontinued ORAL N/A Dec 5, 2005





4. HERITAGE PHARMA AVET

Heritage Pharma Labs Inc Dba Avet Pharmaceuticals Labs Inc has filed for 1 generic for Ribavirin. Given below are the details of the strengths of this generic introduced by Heritage Pharma Avet.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Discontinued ORAL N/A Dec 5, 2005





5. NAVINTA LLC

Navinta Llc has filed for 1 generic for Ribavirin. Given below are the details of the strengths of this generic introduced by Navinta Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
6GM/VIAL

for solution Prescription INHALATION AN Oct 6, 2016





6. SANDOZ

Sandoz Inc has filed for 1 generic for Ribavirin. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Prescription ORAL AB Oct 3, 2006


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Kundl Sandoz GmbH
Langkampfen Sandoz GmbH
United States
Princeton Sandoz Inc
East Hanover Sandoz Incorporated
Spain
Palafolls Sandoz Industrial Products, S.A.
Les Franqueses Del Valles Sandoz Industrial Products S.A.
India
Navi Mumbai Sandoz Private Limited





7. TEVA

Teva Pharmaceuticals Usa Inc has filed for 1 generic for Ribavirin. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

capsule Discontinued ORAL N/A Oct 4, 2004


Manufacturing Plant Locations
New

Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.

Country City Firm Name
United States
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Miami Teva Branded Pharmaceutical Products R & D, Inc.
Horsham Teva Branded Pharmaceutical Products R&D
Fort Dodge TEVA Animal Health Inc
India
Gajraula, Amroha Teva API India Private Ltd.
Bhind Teva API India Ltd- Malanpur
Canada
Scarborough Teva Canada Limited
Markham Teva Canada Limited
Stouffville Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





8. ZYDUS PHARMS USA

Zydus Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Ribavirin. Given below are the details of the strengths of this generic introduced by Zydus Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG

tablet Prescription ORAL AB Dec 5, 2005
600MG

tablet Discontinued ORAL N/A Mar 16, 2007
400MG

tablet Discontinued ORAL N/A Mar 16, 2007
500MG

tablet Discontinued ORAL N/A Apr 18, 2008