VIRAZOLE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Virazole, and what generic alternatives are available?
Virazole is a drug marketed by Bausch and is included in one NDA.
The generic ingredient in VIRAZOLE is ribavirin. There are fifteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ribavirin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Virazole
A generic version of VIRAZOLE was approved as ribavirin by ZYDUS PHARMS USA on October 28th, 2005.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for VIRAZOLE?
- What are the global sales for VIRAZOLE?
- What is Average Wholesale Price for VIRAZOLE?
Summary for VIRAZOLE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 112 |
| Clinical Trials: | 15 |
| Drug Prices: | Drug price information for VIRAZOLE |
| What excipients (inactive ingredients) are in VIRAZOLE? | VIRAZOLE excipients list |
| DailyMed Link: | VIRAZOLE at DailyMed |
Recent Clinical Trials for VIRAZOLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| U.S. Army Medical Research and Development Command | Phase 2 |
| Bausch Health Americas, Inc. | Phase 1 |
| Weill Medical College of Cornell University | Early Phase 1 |
Pharmacology for VIRAZOLE
| Drug Class | Nucleoside Analog Antiviral |
US Patents and Regulatory Information for VIRAZOLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch | VIRAZOLE | ribavirin | FOR SOLUTION;INHALATION | 018859-001 | Dec 31, 1985 | AN | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for VIRAZOLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | VIRAZOLE | ribavirin | FOR SOLUTION;INHALATION | 018859-001 | Dec 31, 1985 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | VIRAZOLE | ribavirin | FOR SOLUTION;INHALATION | 018859-001 | Dec 31, 1985 | ⤷ Sign Up | ⤷ Sign Up |
| Bausch | VIRAZOLE | ribavirin | FOR SOLUTION;INHALATION | 018859-001 | Dec 31, 1985 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for VIRAZOLE
| 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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for VIRAZOLE
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
