VIRAZOLE Drug Patent Profile

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 28^th, 2005.

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

See drug prices for VIRAZOLE

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
Memorial Sloan Kettering Cancer Center	Early Phase 1

See all VIRAZOLE clinical trials

Pharmacology for VIRAZOLE

Drug Class

Nucleoside Analog Antiviral

Paragraph IV (Patent) Challenges for VIRAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIRAZOLE	for Inhalation Solution	ribavirin	6 gm/vial	018859	1	2014-05-22

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

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
Bausch	VIRAZOLE	ribavirin	FOR SOLUTION;INHALATION	018859-001	Dec 31, 1985
Bausch	VIRAZOLE	ribavirin	FOR SOLUTION;INHALATION	018859-001	Dec 31, 1985

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
Mylan S.A.S	Ribavirin Mylan (previously Ribavirin Three Rivers)	ribavirin	EMEA/H/C/001185 Ribavirin Mylan is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (three years of age and older) and adolescents). 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).Please refer also to the interferon alfa-2b summary of product characteristics (SmPC) for prescribing information particular to that product.Naïve patientsAdult patientsRibavirin Mylan 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 serum hepatitis-C-virus (HCV) RNA.Children and adolescentsRibavirin Mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents three 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 serum HCV RNA. When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case-by-case basis (see section 4.4).Previously treatment-failure patientsAdult patientsRibavirin Mylan 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	2010-06-10
BioPartners GmbH	Ribavirin BioPartners	ribavirin	EMEA/H/C/001184 Ribavirin BioPartners is indicated for the treatment of chronic hepatitis-C-virus (HCV) infection in adults, children three 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 patientsAdult patientsRibavirin BioPartners 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) (see section 4.4)Children three years of age and older and adolescentsRibavirin BioPartners is intended for use, in a combination regimen with interferon alfa-2b, for the treatment of children three years of age and older and adolescents, 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 to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4).Previous-treatment-failure patientsAdult patientsRibavirin BioPartners 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 alfa monotherapy but who have subsequently relapsed (see section 5.1).	Withdrawn	yes	no	no	2010-04-06
Schering-Plough Europe	Cotronak	ribavirin	EMEA/H/C/000247 Cotronak is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b. Cotronak monotherapy must not be used.There is no safety or efficacy information on the use of Cotronak with other forms of interferon (i.e., not alfa-2b).Please refer also to the peginterferon alfa-2b or interferon alfa-2b Summary of Product Characteristics (SPC) for prescribing information particular to that product.	Withdrawn	no	no	no	1999-05-07

International Patents for VIRAZOLE

See the table below for patents covering VIRAZOLE around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	216886
European Patent Office	1240899
Belgium	826777
Canada	2278158
Yugoslavia	61598
Norway	138376
Japan	S59144773	MANUFACTURE OF N-SUBSTITUTED 1,2,4-TRIAZOLE

VIRAZOLE Market Analysis and Financial Projection Experimental

Respiratory Syncytial Virus (RSV) Therapeutics: The Market Dynamics and Financial Trajectory of Virazole

Introduction

Respiratory Syncytial Virus (RSV) is a common and potentially severe respiratory virus that affects individuals of all ages, particularly infants, young children, and older adults with weakened immune systems. The RSV therapeutics market has been gaining significant attention due to the development of new treatments and the increasing incidence of RSV infections. One of the key players in this market is Virazole, an antiviral medication that contains Ribavirin.

Market Size and Growth

The RSV therapeutics market is projected to experience substantial growth over the coming years. By 2031, the market is expected to reach USD 4.05 billion, growing at a Compound Annual Growth Rate (CAGR) of 14.5% from 2024 to 2031[1].

Virazole: An Overview

Virazole, which contains the antiviral drug Ribavirin, is a crucial component of the RSV therapeutics market. Ribavirin is known for its broad-spectrum antiviral activity and is effective against RSV. It can be administered in various forms, including aerosolized solutions for direct lung delivery, which enhances its efficacy[4].

Market Segments and Growth Drivers

By Drug Type

The antiviral medication segment, which includes Virazole, is anticipated to grow faster than any other segment in the RSV therapeutics market. This segment is projected to grow at a CAGR of 15.9% from 2024 to 2032, driven by the increasing incidence of RSV and the effectiveness of antiviral drugs like Ribavirin and Palivizumab[4].

By Dosage Form

Injectables dominate the RSV market, but the versatility of Virazole in different administration forms, such as aerosolized solutions, contributes to its growth. The ability to deliver the drug directly to the lungs enhances its efficacy and patient compliance[4].

By Treatment Type

The use of antiviral medications like Virazole is becoming more prevalent as healthcare systems worldwide seek effective treatments for RSV. The World Health Organization's (WHO) endorsement of new RSV vaccines and prophylactic treatments further underscores the global commitment to combating this illness[4].

Regional Analysis

The Asia Pacific region is expected to see significant growth in the RSV therapeutics market, including the segment for Virazole. Countries with advanced healthcare infrastructure, such as Japan and Australia, are driving this growth due to higher penetration of RSV treatments. The varying frequency of RSV across different nations in the Asia Pacific region also contributes to the market's expansion[1].

Competitive Landscape

The RSV therapeutics market is highly competitive, with major players including Bavarian Nordic, Merck Sharp and Dohme B.V, Pfizer Inc., AstraZeneca Plc, Janssen Pharmaceuticals, Moderna Inc, GlaxoSmithKline Plc, and others. Virazole, as a product of these or similar companies, benefits from the research and development investments and strategic initiatives of these pharmaceutical giants[1].

Financial Trajectory

The financial trajectory of Virazole is closely tied to the overall growth of the RSV therapeutics market. With the market expected to reach USD 4.05 billion by 2031, the antiviral medication segment, which includes Virazole, is poised for significant financial gains. The CAGR of 15.9% for antiviral medications from 2024 to 2032 indicates a lucrative future for Virazole and similar drugs[1][4].

Impact of Regulatory Endorsements

The WHO's endorsement of new RSV vaccines and prophylactic treatments has catalyzed the pharmaceutical industry to prioritize RSV vaccine development and antiviral medications like Virazole. This regulatory support is a key driver of market growth and financial success for these treatments[4].

Distribution Channels

The distribution of Virazole and other RSV therapeutics is primarily through drug stores, hospital pharmacies, clinics, and retail pharmacies. The ease of access and distribution channels contribute to the market's growth and the financial performance of these drugs[1].

Future Outlook

As the world becomes better at diagnosing RSV and spreading awareness about the virus, the demand for antiviral drugs like Virazole is expected to increase. This increased demand, coupled with ongoing innovations in treatment options, will drive the market forward and lead to further financial growth for Virazole and the broader RSV therapeutics market[4].

Key Takeaways

• The RSV therapeutics market, including Virazole, is expected to grow significantly, reaching USD 4.05 billion by 2031.
• The antiviral medication segment, which includes Virazole, is projected to grow at a CAGR of 15.9% from 2024 to 2032.
• The versatility of Virazole in different administration forms enhances its efficacy and market appeal.
• Regulatory endorsements and increasing awareness of RSV are key drivers of market growth.
• The Asia Pacific region is expected to contribute significantly to the market's expansion.

FAQs

What is Virazole and how is it used in RSV treatment?

Virazole is an antiviral medication that contains Ribavirin, used to treat RSV infections. It can be administered in various forms, including aerosolized solutions for direct lung delivery.

What is the projected growth rate of the RSV therapeutics market?

The RSV therapeutics market is expected to grow at a CAGR of 14.5% from 2024 to 2031, reaching USD 4.05 billion by 2031.

Which segment of the RSV therapeutics market is growing the fastest?

The antiviral medication segment, which includes Virazole, is growing the fastest with a CAGR of 15.9% from 2024 to 2032.

What are the key distribution channels for Virazole and other RSV therapeutics?

The key distribution channels include drug stores, hospital pharmacies, clinics, and retail pharmacies.

How does the WHO's endorsement impact the market for Virazole and other RSV treatments?

The WHO's endorsement of new RSV vaccines and prophylactic treatments has catalyzed the pharmaceutical industry to prioritize RSV vaccine development and antiviral medications, driving market growth and financial success.

Sources

1. Respiratory Syncytial Virus [RSV] Therapeutics Market Share - SNS Insider
2. THE PRICE OF SOVALDI AND ITS IMPACT ON THE U.S. HEALTH - GovInfo
3. Drugs to Watch 2023 - GPHA Buzz
4. Respiratory Syncytial Virus Market Size | Report 2032 - Astute Analytica
5. A VIRAGEN THERAPEUTICS, INC. ANNUAL REPORT - Investors.Vaxart