Virazole is a drug owned by Bausch Health Us Llc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 21, 2017. Details of Virazole'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). | |||
| US6150337 | Specific modulation of Th1/Th2 cytokine expression by Ribavirin in activated T-lymphocytes |
Nov, 2017
(7 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Virazole 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 Virazole's family patents as well as insights into ongoing legal events on those patents.
Virazole's Family Patents
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Generic Launch
Generic Release Date:
Virazole's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 21, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Virazole Generic API suppliers:
Ribavirin is the generic name for the brand Virazole. 8 different companies have already filed for the generic of Virazole, with Zydus Pharms Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Virazole's generic
How can I launch a generic of Virazole before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Virazole's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Virazole'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 Virazole -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 6 gm/vial | 22 May, 2014 | 1 | 06 Oct, 2016 | 21 Nov, 2017 | Eligible |
Alternative Brands for Virazole
Virazole which is used for treating infections and infestations by modulating cytokine responses in lymphocytes., 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ribavirin, Virazole's active ingredient. Check the complete list of approved generic manufacturers for Virazole
About Virazole
Virazole is a drug owned by Bausch Health Us Llc. It is used for treating infections and infestations by modulating cytokine responses in lymphocytes. Virazole uses Ribavirin as an active ingredient. Virazole was launched by Bausch in 1985.
Approval Date:
Virazole was approved by FDA for market use on 31 December, 1985.
Active Ingredient:
Virazole uses Ribavirin as the active ingredient. Check out other Drugs and Companies using Ribavirin ingredient
Treatment:
Virazole is used for treating infections and infestations by modulating cytokine responses in lymphocytes.
Dosage:
Virazole is available in for solution form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 6GM/VIAL | FOR SOLUTION | Prescription | INHALATION |