RIBAVIRIN - Generic Drug Details

What are the generic sources for ribavirin and what is the scope of patent protection?

Ribavirin is the generic ingredient in five branded drugs marketed by Merck Sharp Dohme, Chartwell Rx, Aurobindo Pharma, Teva, Zydus Pharms Usa, Navinta Llc, Bausch, Schering, Roche, Beximco Pharms Usa, Heritage Pharma Avet, and Sandoz, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for ribavirin. Eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for RIBAVIRIN

US Patents:	0
Tradenames:	5
Applicants:	12
NDAs:	16
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	1,029
Patent Applications:	5,937
Drug Prices:	Drug price trends for RIBAVIRIN
What excipients (inactive ingredients) are in RIBAVIRIN?	RIBAVIRIN excipients list
DailyMed Link:	RIBAVIRIN at DailyMed

See drug prices for RIBAVIRIN

Recent Clinical Trials for RIBAVIRIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cancer Institute (NCI)	Phase 4
Liverpool School of Tropical Medicine	Phase 1/Phase 2
Peking University People's Hospital	Phase 4

See all RIBAVIRIN clinical trials

Generic filers with tentative approvals for RIBAVIRIN

Applicant	Application No.	Strength	Dosage Form
		40MG/ML	SOLUTION; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for RIBAVIRIN

Drug Class

Nucleoside Analog Antiviral

Medical Subject Heading (MeSH) Categories for RIBAVIRIN

Antimetabolites

Antiviral Agents

Anatomical Therapeutic Chemical (ATC) Classes for RIBAVIRIN

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for RIBAVIRIN

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 RIBAVIRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	RIBAVIRIN	ribavirin	CAPSULE;ORAL	076277-001	Oct 4, 2004		DISCN	No	No
Zydus Pharms Usa	RIBAVIRIN	ribavirin	TABLET;ORAL	077094-001	Dec 5, 2005	AB	RX	No	No
Zydus Pharms Usa	RIBAVIRIN	ribavirin	TABLET;ORAL	077094-003	Mar 16, 2007		DISCN	No	No
Aurobindo Pharma	RIBAVIRIN	ribavirin	TABLET;ORAL	079111-001	Sep 17, 2009	AB	RX	No	No
Beximco Pharms Usa	RIBAVIRIN	ribavirin	TABLET;ORAL	202546-002	Aug 12, 2014		DISCN	No	No
Beximco Pharms Usa	RIBAVIRIN	ribavirin	TABLET;ORAL	202546-003	Aug 12, 2014		DISCN	No	No

Expired US Patents for RIBAVIRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	REBETOL	ribavirin	SOLUTION;ORAL	021546-001	Jul 29, 2003	6,524,570*PED
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-001	Jun 3, 1998	6,177,074*PED
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-002	Jul 25, 2001	6,524,570*PED
Schering	REBETOL	ribavirin	SOLUTION;ORAL	021546-001	Jul 29, 2003	5,767,097*PED
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-001	Jun 3, 1998	4,211,771
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-002	Jul 25, 2001	6,335,032*PED

EU/EMA Drug Approvals for RIBAVIRIN

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
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
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
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
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
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

Market Dynamics and Financial Trajectory for Ribavirin

Introduction to Ribavirin

Ribavirin is a nucleoside analogue antiviral drug that has been widely used in the treatment of various viral infections, most notably chronic hepatitis C (HCV). It works by preventing the hepatitis C virus from spreading inside the body and is often used in combination with other antiviral drugs like interferons or direct-acting antivirals (DAAs) such as sofosbuvir[1][2][4].

Market Growth and Forecast

The ribavirin market is anticipated to experience significant growth over the forecast period of 2022-2029. According to Data Bridge Market Research, the market is expected to grow at a Compound Annual Growth Rate (CAGR) of 16.40% during this period. This growth is driven by several key factors:

• Increasing Incidence of Chronic Hepatitis C: The rise in global cases of chronic hepatitis C is a major driver of the market's growth[1].
• Rising Healthcare Expenditure: Increased healthcare spending in various regions is contributing to the market's expansion[1].
• Growing Prevalence of Other Diseases: The increasing prevalence of thyroid cancer and other conditions for which ribavirin is used also supports market growth[1].
• Government Initiatives and Awareness: Rising government initiatives and public awareness campaigns are further boosting the market[1].

Market Segmentation

The ribavirin market is segmented based on several criteria:

• Type: Ribavirin is available in different purities, such as 98% and 99%[1].
• Drug Class: It falls under categories like inhaled anti-infectives and purine nucleosides[1].
• Demographic: The drug is used in both adult and pediatric populations[1].
• Application: Ribavirin is used to treat conditions including hemorrhagic fever, renal impairment, thyroid cancer, and chronic hepatitis C[1].
• Dosage Form: It is available in various forms such as tablets, inhalation solutions, and oral solutions[1].
• End-Users: The primary end-users include clinics, hospitals, and other healthcare facilities[1].
• Distribution Channel: The drug is distributed through hospital pharmacies, retail pharmacies, and online pharmacies[1].

Regional Analysis

The ribavirin market is analyzed across various regions, including North America, Europe, Asia-Pacific, and others.

• North America: This region dominates the market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure[1].
• Asia-Pacific: This region is expected to grow significantly due to increasing research and development activities and rising government support[1].

Financial Trajectory

Revenue and Market Size

The global ribavirin market has seen substantial revenue in recent years. For instance, the HCV market, which includes ribavirin, generated significant revenues, with figures like $19.1 billion in 2015 alone[3].

Price Dynamics

The market has experienced price erosion in recent years, particularly in the HCV treatment segment. However, this trend is expected to stabilize as market dynamics adjust. For example, in France, there is an annual cap on HCV drug expenditures, which limits price erosion and translates into more patients being treated without increasing revenues[3].

Production and Supply Forecast

The production capacity and revenue forecasts for ribavirin indicate continued growth. Global forecasts suggest increased production and revenue in regions like North America, Europe, China, and Japan from 2023 to 2027[4].

Consumption and Demand Forecast

The demand for ribavirin is expected to rise, driven by the increasing incidence of viral infections and the need for effective antiviral treatments. Forecasted consumption analysis by region highlights growing demand in North America, Europe, Asia-Pacific, and Latin America[4].

Competitive Landscape

The ribavirin market is competitive, with several key players vying for market share.

• Major Players: Companies like Gilead, Bristol-Myers Squibb, and Janssen are prominent in the market. Gilead, in particular, has a strong position due to its differential pricing strategies for drugs like Sovaldi and Harvoni[3].
• Market Share: The market share is distributed among these players, with Gilead holding a significant portion due to its widely recommended DAA regimens that include ribavirin[3].

Challenges and Opportunities

Challenges

• Price Erosion: The decline in prices due to intense competition and government caps on expenditures poses a challenge to maintaining revenue streams[3].
• Declining Patient Pool: The success in treating HCV has led to a decline in the number of diagnosed prevalent cases, which threatens the sustainability of future revenues[3].

Opportunities

• Emerging Markets: The rise in research and development activities and the emergence of new markets provide beneficial opportunities for the ribavirin market[1].
• Improving Healthcare Infrastructure: Continuous clinical trials and improving healthcare infrastructure will create new opportunities for market growth[1].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the ribavirin market. While it has disrupted supply chains and affected production capacities, it has also highlighted the need for effective antiviral treatments. The report analyzes the impact of COVID-19 on the ribavirin industry and provides professional advice on navigating the post-pandemic period[4].

Patient Epidemiology and Treatment Outcomes

Studies have shown that ribavirin, when used in combination with other antivirals like sofosbuvir, can achieve sustained virologic response (SVR) even with shorter treatment durations. For example, a patient achieved SVR with just 27 days of therapy with sofosbuvir and weight-based ribavirin, highlighting the potential for shorter and more effective treatment regimens[2].

Key Takeaways

• Market Growth: The ribavirin market is expected to grow at a CAGR of 16.40% from 2022 to 2029.
• Regional Dominance: North America currently dominates the market, with Asia-Pacific expected to grow significantly.
• Price Dynamics: Price erosion is a challenge, but market dynamics are expected to stabilize.
• Emerging Opportunities: New markets and improving healthcare infrastructure offer growth opportunities.
• Patient Outcomes: Ribavirin can achieve SVR with shorter treatment durations when combined with other antivirals.

FAQs

What is the primary use of ribavirin?

Ribavirin is primarily used in the treatment of chronic hepatitis C, often in combination with other antiviral drugs.

Which regions are expected to drive the growth of the ribavirin market?

North America and Asia-Pacific are expected to be key drivers of the ribavirin market growth.

What are the main challenges facing the ribavirin market?

Price erosion and a declining patient pool due to successful HCV treatments are significant challenges.

How does the COVID-19 pandemic impact the ribavirin market?

The pandemic has disrupted supply chains but also highlighted the need for effective antiviral treatments, providing both challenges and opportunities.

What is the significance of ribavirin in combination therapy?

Ribavirin, when used in combination with other antivirals like sofosbuvir, can achieve sustained virologic response (SVR) even with shorter treatment durations.

Sources

1. Data Bridge Market Research: Global Ribavirin Market - Industry Trends and Forecast to 2029.
2. Oxford University Press: Sustained Virologic Response for Chronic Hepatitis C Infection After Short-Term Therapy with Sofosbuvir and Ribavirin.
3. Drug Development & Delivery: Recent Success in HCV Treatment Brings Relief to Patients but Challenges to Companies.
4. GlobeNewswire: Ribavirin Market Projected to Grow at a Impressive CAGR During the 2022-2027 Forecast Timeframe.