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. Six 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:	3
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		DISCN	Yes	No

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/000246Rebetol 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/001064Ribavirin 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/001018Ribavirin 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/001185Ribavirin 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

International Patents for VIRAZOLE

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

Country	Patent Number	Title	Estimated Expiration
Argentina	199463	SINTESIS DE NUCLEOSIDOS DE 1,2,4-TRIAZOL-3-SUSTITUIDOS
Argentina	205339	SINTESIS DE 1,2,4-TRIAZOLO-3-CARBOXAMIDAS UTILES COMO AGENTES ANTIVIRALES
Argentina	207138	METODO PARA LA OBTENCION DE 1,2,4-TRIAZOLES N-SUBSTITUIDOS Y SUS SALES DE ADICION
Argentina	224992	METODO PARA LA OBTENCION DE NUCLEOSIDOS DE 1-(BETA-D-RIBOFURANOSIL)-1,2,4-TRIAZOL-3-CARBOXAMIDA

Last updated: May 27, 2026

VIRAZOLE market dynamics and financial trajectory: sales, payer demand, and exclusivity-driven risk

VIRAZOLE’s commercial outlook hinges on (1) product-level patent and exclusivity status that governs generic or competitive entry timing, (2) payer coverage durability and formulary positioning, and (3) channel performance in relevant therapeutic segments. Published, market-actionable financials (revenue, unit trend, regional breakdown) and IP/exclusivity details for “VIRAZOLE” are not available in the supplied source set, so a complete, accurate market dynamics and financial trajectory profile cannot be produced.

What is VIRAZOLE and what therapeutic use drives demand?

Featured snippet: Demand is determined by the approved indication(s), dose form(s), and payer willingness to cover the drug at the required price. For VIRAZOLE, those specifics and confirmed regulatory identifiers are not provided here.

Which active ingredient does “VIRAZOLE” correspond to?

Without a confirmed active ingredient and label, demand drivers cannot be mapped to epidemiology, standard-of-care positioning, and competitive alternatives.

What dosage forms and strengths exist?

Market dynamics differ sharply by dosage form (oral vs. injectable vs. topical), dosing frequency, and patient adherence requirements. No dosage-form data is provided.

How do patent expiry and exclusivity timelines shape VIRAZOLE’s revenue trajectory?

Featured snippet: Revenue typically declines when generics or authorized competitors enter after patent or exclusivity expiry, especially if market access shifts to lower-cost alternatives.

When does VIRAZOLE lose exclusivity (US and EU)?

No confirmed patent estate, exclusivity type (NCE, 3(b), pediatric, orphan), or jurisdictional dates are available for VIRAZOLE, so expiration-driven decline cannot be scheduled.

What generic entry risks exist for VIRAZOLE (Paragraph IV)?

A Paragraph IV timeline requires identified ANDA filers, Orange Book listed patents, and litigation records. None are provided.

Biosimilar risk or not: does VIRAZOLE face biologic competition?

If VIRAZOLE is not a biologic, biosimilar risk is irrelevant. Without product classification, this cannot be stated.

What is the Orange Book status of VIRAZOLE and what patents are listed?

Featured snippet: Orange Book listings determine the “regulatory blocking” patents that an ANDA must challenge under 21 U.S.C. § 355(j).

For VIRAZOLE, no Orange Book entry, listed patents, or assignee information is provided, so the patent coverage scope and challenge landscape cannot be quantified.

How many patents cover VIRAZOLE and which are method-of-use vs formulation?

No patent list is provided, so there is no basis to split by:

• method-of-use
• formulation/composition
• manufacturing/process
• polymorphs/salts
• device/delivery systems

How does VIRAZOLE compare with competing drugs in the same class?

Featured snippet: Share loss risk rises when competitors offer comparable efficacy and better pricing or improved safety/tolerability that changes formulary status.

No competitor set, interchangeability class, or comparative efficacy/safety claims for VIRAZOLE are provided.

Which competitors are substitutes at the payer formulary level?

Substitution depends on therapeutic equivalence and payer contracting structures. Not available.

What pricing leverage does VIRAZOLE have versus alternatives?

Pricing power is driven by outcomes evidence, health economic positioning, and exclusivity protection. Not available.

What patent litigation affects VIRAZOLE’s commercialization and generic launch timing?

Featured snippet: Litigation can delay generic entry through automatic stays (Paragraph IV) and settlement-driven “carve-out” timelines.

No litigation docket, court, patent numbers, settlement terms, or stay periods are provided.

Which companies are challenging VIRAZOLE and with what claims?

No challengers or ANDA/ANDA amendment details are provided.

What settlement agreements control launch dates?

No settlement details are provided.

What is VIRAZOLE’s FDA regulatory status and what does it imply for market access?

Featured snippet: FDA approval pathway and post-approval changes affect patent position, labeling scope, and coverage by formularies and PBMs.

No FDA label status, approval year, supplement history, or REMS requirements are provided for VIRAZOLE.

Was VIRAZOLE approved through NME, 505(b)(2), or ANDA?

Not available.

Are there label expansions or safety communications that alter utilization?

Not available.

Commercial landscape: where is VIRAZOLE sold and how concentrated is demand?

Featured snippet: Revenue concentration by geography and channel determines resilience against generic erosion and payer re-contracting.

No region-level revenue, wholesaler coverage, institutional vs retail mix, or reimbursement coverage data is provided.

US vs ex-US revenue exposure for VIRAZOLE

Not available.

Channel dynamics: hospital vs retail and payer mix

Not available.

What financial trajectory should investors expect for VIRAZOLE across cycles?

Featured snippet: The typical pattern is high-margin growth under exclusivity, then margin compression post-entry driven by pricing pressure and market share shifts.

A complete, accurate financial trajectory requires:

• historical revenue and guidance
• gross margin trend and rebate structure
• unit and TRx trend
• SG&A intensity and distribution economics
• contract updates and payer coverage changes None are provided.

Key takeaways

• VIRAZOLE market dynamics and financial trajectory cannot be mapped to exclusivity, patent expiry, litigation, FDA status, or competitive substitution without confirmed product identifiers and source-backed IP/regulatory records.
• The revenue trajectory for any small-molecule brand is primarily determined by Orange Book blocking patents, Paragraph IV challenges, and settlement-driven launch timing. Those inputs are not available here for VIRAZOLE.
• A defensible investment, licensing, or litigation view requires the confirmed active ingredient, Orange Book patent list, FDA approval details, and related court records.

FAQs

1. Does VIRAZOLE have Orange Book listed patents that block generic entry?
2. Are there Paragraph IV ANDA challenges against VIRAZOLE, and what are the settlement outcomes?
3. How much of VIRAZOLE demand is payer-driven versus patient-initiated procurement?
4. What label changes or safety communications could alter VIRAZOLE utilization and reimbursement?
5. Which therapeutic competitors most threaten VIRAZOLE share after exclusivity loss?

References (APA)

1. (No cited sources provided in the prompt.)

DrugChatter Q&A for VIRAZOLE

How does virazole treat rsv in children?