Rebetol is a drug owned by Schering Corp. It is protected by 12 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 05, 2023. Details of Rebetol's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US6790837 (Pediatric) | Ribavirin syrup formulations |
Oct, 2023
(1 year, 6 months ago) |
Expired
|
| US6790837 | Ribavirin syrup formulations |
Apr, 2023
(2 years ago) |
Expired
|
|
US6172046 (Pediatric) | Combination therapy for eradicating detectable HCV-RNA in patients having chronic Hepatitis C infection |
Mar, 2018
(7 years ago) |
Expired
|
|
US6472373 (Pediatric) | Combination therapy for eradicating detectable HCV-RNA in antiviral treatment naive patients having chronic hepatitis C infection |
Mar, 2018
(7 years ago) |
Expired
|
| US6472373 | Combination therapy for eradicating detectable HCV-RNA in antiviral treatment naive patients having chronic hepatitis C infection |
Sep, 2017
(7 years ago) |
Expired
|
| US6172046 | Combination therapy for eradicating detectable HCV-RNA in patients having chronic Hepatitis C infection |
Sep, 2017
(7 years ago) |
Expired
|
|
US6524570 (Pediatric) | Polyethylene glycol modified interferon therapy |
May, 2017
(7 years ago) |
Expired
|
|
US6461605 (Pediatric) | Continuous low-dose cytokine infusion therapy |
May, 2017
(7 years ago) |
Expired
|
|
US6177074 (Pediatric) | Polyethylene glycol modified interferon therapy |
May, 2017
(7 years ago) |
Expired
|
| US6461605 | Continuous low-dose cytokine infusion therapy |
Nov, 2016
(8 years ago) |
Expired
|
| US6524570 | Polyethylene glycol modified interferon therapy |
Nov, 2016
(8 years ago) |
Expired
|
| US6177074 | Polyethylene glycol modified interferon therapy |
Nov, 2016
(8 years ago) |
Expired
|
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 Rebetol's patents.
Latest Legal Activities on Rebetol's Patents
Given below is the list of recent legal activities going on the following patents of Rebetol.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Correspondence Address Change Critical | 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 Critical | 14 Sep, 2004 | US6790837 |
| Patent Issue Date Used in PTA Calculation Critical | 14 Sep, 2004 | US6790837 |
| Issue Notification Mailed Critical | 26 Aug, 2004 | US6790837 |
| Receipt into Pubs | 20 Aug, 2004 | US6790837 |
| Dispatch to FDC | 19 Aug, 2004 | US6790837 |
| Application Is Considered Ready for Issue Critical | 19 Aug, 2004 | US6790837 |
| Receipt into Pubs | 18 Aug, 2004 | US6790837 |
US patents provide insights into the exclusivity only within the United States, but Rebetol is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Rebetol's family patents as well as insights into ongoing legal events on those patents.
Rebetol's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rebetol's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 05, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rebetol Generic API suppliers:
Ribavirin is the generic name for the brand Rebetol. 8 different companies have already filed for the generic of Rebetol, with Zydus Pharms Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Rebetol's generic
How can I launch a generic of Rebetol before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Rebetol's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Rebetol's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Rebetol -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 200 mg |
Alternative Brands for Rebetol
Rebetol which is used for treating hepatitis C viral infection., has several other brand drugs using the same active ingredient (Ribavirin). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Bausch |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ribavirin, Rebetol's active ingredient. Check the complete list of approved generic manufacturers for Rebetol
About Rebetol
Rebetol is a drug owned by Schering Corp. It is used for treating hepatitis C viral infection. Rebetol uses Ribavirin as an active ingredient. Rebetol was launched by Schering in 2003.
Approval Date:
Rebetol was approved by FDA for market use on 29 July, 2003.
Active Ingredient:
Rebetol uses Ribavirin as the active ingredient. Check out other Drugs and Companies using Ribavirin ingredient
Treatment:
Rebetol is used for treating hepatitis C viral infection.
Dosage:
Rebetol is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG/ML | SOLUTION | Discontinued | ORAL |
Rebetol is a drug owned by Merck Sharp And Dohme Corp. It is protected by 10 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 21, 2018. Details of Rebetol's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US6172046 (Pediatric) | Combination therapy for eradicating detectable HCV-RNA in patients having chronic Hepatitis C infection |
Mar, 2018
(7 years ago) |
Expired
|
|
US6472373 (Pediatric) | Combination therapy for eradicating detectable HCV-RNA in antiviral treatment naive patients having chronic hepatitis C infection |
Mar, 2018
(7 years ago) |
Expired
|
| US6472373 | Combination therapy for eradicating detectable HCV-RNA in antiviral treatment naive patients having chronic hepatitis C infection |
Sep, 2017
(7 years ago) |
Expired
|
| US6172046 | Combination therapy for eradicating detectable HCV-RNA in patients having chronic Hepatitis C infection |
Sep, 2017
(7 years ago) |
Expired
|
|
US6177074 (Pediatric) | Polyethylene glycol modified interferon therapy |
May, 2017
(7 years ago) |
Expired
|
|
US6524570 (Pediatric) | Polyethylene glycol modified interferon therapy |
May, 2017
(7 years ago) |
Expired
|
|
US6461605 (Pediatric) | Continuous low-dose cytokine infusion therapy |
May, 2017
(7 years ago) |
Expired
|
| US6177074 | Polyethylene glycol modified interferon therapy |
Nov, 2016
(8 years ago) |
Expired
|
| US6524570 | Polyethylene glycol modified interferon therapy |
Nov, 2016
(8 years ago) |
Expired
|
| US6461605 | Continuous low-dose cytokine infusion therapy |
Nov, 2016
(8 years ago) |
Expired
|
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 Rebetol's patents.
Latest Legal Activities on Rebetol's Patents
Given below is the list of recent legal activities going on the following patents of Rebetol.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Correspondence Address Change Critical | 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 Critical | 14 Sep, 2004 | US6790837 |
| Patent Issue Date Used in PTA Calculation Critical | 14 Sep, 2004 | US6790837 |
| Issue Notification Mailed Critical | 26 Aug, 2004 | US6790837 |
| Receipt into Pubs | 20 Aug, 2004 | US6790837 |
| Dispatch to FDC | 19 Aug, 2004 | US6790837 |
| Application Is Considered Ready for Issue Critical | 19 Aug, 2004 | US6790837 |
| Receipt into Pubs | 18 Aug, 2004 | US6790837 |
US patents provide insights into the exclusivity only within the United States, but Rebetol is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Rebetol's family patents as well as insights into ongoing legal events on those patents.
Rebetol's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rebetol's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 21, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rebetol Generic API suppliers:
Ribavirin is the generic name for the brand Rebetol. 8 different companies have already filed for the generic of Rebetol, with Zydus Pharms Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Rebetol's generic
How can I launch a generic of Rebetol before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Rebetol's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Rebetol's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Rebetol -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 200 mg |
Alternative Brands for Rebetol
Rebetol which is used for treating hepatitis C viral infection., has several other brand drugs using the same active ingredient (Ribavirin). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Bausch |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ribavirin, Rebetol's active ingredient. Check the complete list of approved generic manufacturers for Rebetol
About Rebetol
Rebetol is a drug owned by Merck Sharp And Dohme Corp. It is used for treating hepatitis C viral infection. Rebetol uses Ribavirin as an active ingredient. Rebetol was launched by Merck Sharp Dohme in 1998.
Approval Date:
Rebetol was approved by FDA for market use on 03 June, 1998.
Active Ingredient:
Rebetol uses Ribavirin as the active ingredient. Check out other Drugs and Companies using Ribavirin ingredient
Treatment:
Rebetol is used for treating hepatitis C viral infection.
Dosage:
Rebetol is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |
| 200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy** | CAPSULE | Discontinued | ORAL |