REBETOL Drug Patent Profile

Which patents cover Rebetol, and when can generic versions of Rebetol launch?

Rebetol is a drug marketed by Merck Sharp Dohme and Schering and is included in two NDAs.

The generic ingredient in REBETOL 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 Rebetol

A generic version of REBETOL was approved as ribavirin by ZYDUS PHARMS USA on October 28^th, 2005.

Summary for REBETOL

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	95
Drug Prices:	Drug price information for REBETOL
What excipients (inactive ingredients) are in REBETOL?	REBETOL excipients list
DailyMed Link:	REBETOL at DailyMed

See drug prices for REBETOL

Recent Clinical Trials for REBETOL

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

Sponsor	Phase
Tanta University	Phase 2/Phase 3
Memorial Sloan Kettering Cancer Center	Early Phase 1
Weill Medical College of Cornell University	Early Phase 1

See all REBETOL clinical trials

US Patents and Regulatory Information for REBETOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-001	Jun 3, 1998		DISCN	No	No
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-002	Jul 25, 2001		DISCN	Yes	No
Schering	REBETOL	ribavirin	SOLUTION;ORAL	021546-001	Jul 29, 2003		DISCN	Yes	No

Expired US Patents for REBETOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	REBETOL	ribavirin	SOLUTION;ORAL	021546-001	Jul 29, 2003
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-001	Jun 3, 1998
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-002	Jul 25, 2001
Schering	REBETOL	ribavirin	SOLUTION;ORAL	021546-001	Jul 29, 2003
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-002	Jul 25, 2001
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-001	Jun 3, 1998

EU/EMA Drug Approvals for REBETOL

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 REBETOL

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

Country	Patent Number	Title	Estimated Expiration
Austria	A465772
Luxembourg	69626
Norway	20004329
Taiwan	568787
European Patent Office	1240899
Austria	271063

REBETOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ribavirin (Rebetol)

Introduction

Ribavirin, commonly known by its brand name Rebetol, is a nucleoside analogue antiviral drug used primarily in the treatment of chronic hepatitis C, often in combination with other medications. Here, we delve into the market dynamics and financial trajectory of ribavirin, highlighting key drivers, challenges, and future outlook.

Market Growth and Drivers

The ribavirin market is anticipated to experience significant growth, driven by several key factors:

Increasing Incidence of Chronic Hepatitis C

The global rise in chronic hepatitis C cases is a major driver for the ribavirin market. As the prevalence of this disease increases, so does the demand for effective treatments like ribavirin[1].

Rising Healthcare Expenditure

Growing healthcare expenditure globally is another significant factor. Increased spending on healthcare infrastructure and treatments contributes to the market's expansion[1].

Clinical Trials and Research

The ongoing clinical trials and research in antiviral drug development are crucial for the market's growth. These activities not only improve existing treatments but also open up new therapeutic applications for ribavirin[3].

Government Initiatives and Awareness

Government initiatives and rising awareness about viral infections and their treatments also positively impact the market. These efforts lead to better diagnosis rates and increased treatment adherence[1].

Market Segmentation

The ribavirin market is segmented based on several criteria:

Type and Drug Class

Ribavirin is categorized by purity levels (98% and 99%) and drug class (inhaled anti-infectives, purine nucleosides)[1].

Demographic and Application

It is used across various demographics (adult and pediatric) and for different applications, including hemorrhagic fever, renal impairment, thyroid cancer, and chronic hepatitis C[1].

Dosage Form and End-Users

The drug is available in various dosage forms (tablets, inhalation solution, oral solution) and is used by different end-users (clinics, hospitals, others)[1].

Distribution Channel

The distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies[1].

Financial Performance and Projections

Current Market Size and Growth Rate

The ribavirin market is expected to grow at a Compound Annual Growth Rate (CAGR) of 16.40% from 2022 to 2029. This growth is driven by the increasing demand for antiviral treatments and the expanding healthcare infrastructure in emerging markets[1].

Regional Analysis

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

Challenges and Restraints

Despite the positive growth trajectory, the ribavirin market faces several challenges:

Regulatory Hurdles

Stringent regulatory requirements pose a significant barrier to market expansion. Compliance with these regulations can be costly and time-consuming[3].

Side Effects and Adverse Reactions

Ribavirin can cause severe side effects, such as anemia, which necessitates dose adjustments and careful patient monitoring. These side effects can limit its use and impact market growth[1].

Emerging Competitors

The emergence of new competing therapies, such as direct-acting antivirals (DAAs), can restrict the market expansion of ribavirin. DAAs like Sovaldi, Harvoni, and Zepatier have become preferred treatments for chronic hepatitis C, challenging ribavirin's market share[4].

Market Opportunities

Several opportunities exist for the ribavirin market:

Research Partnerships and Technological Advancements

Investing in research partnerships and leveraging technological advancements can improve drug formulations, reduce adverse effects, and enhance production and distribution efficiency[3].

Expanding Distribution Channels

Enhancing distribution channels, particularly in emerging markets, can increase accessibility and affordability of ribavirin. This includes partnerships with healthcare providers and the development of generic versions[3].

Digital Marketing

Utilizing digital marketing strategies can help reach wider audiences and boost awareness about ribavirin, potentially increasing demand and market penetration[3].

Porter’s Five Forces Analysis

Understanding the competitive landscape through Porter’s Five Forces Analysis is crucial:

Threat of New Entrants

The threat of new entrants is moderate due to the high barriers of entry, including stringent regulatory requirements and significant research and development costs[3].

Bargaining Power of Suppliers

The bargaining power of suppliers is relatively low as the market is dominated by a few key players, allowing them to control supply chains effectively[3].

Bargaining Power of Buyers

The bargaining power of buyers is moderate, influenced by factors such as government policies, healthcare budgets, and the availability of alternative treatments[3].

Threat of Substitute Products

The threat of substitute products is high due to the emergence of DAAs and other antiviral treatments that offer higher efficacy rates and fewer side effects[4].

Competitive Rivalry Among Existing Competitors

The competitive rivalry is intense, with major pharmaceutical companies like Gilead, Merck, and Bristol-Myers Squibb competing for market share in the HCV treatment space[4].

Global Outlook

The treatment landscape for chronic hepatitis C has undergone significant changes with the introduction of DAAs. However, ribavirin remains a viable treatment option, especially in combination therapies.

Disease Prevalence and Treatment Rates

The high treatment rates and low incidence rates of chronic hepatitis C in many countries mean that the patient population seeking treatment is decreasing. This trend could impact the long-term sustainability of HCV drug revenues[4].

Pricing Dynamics

The pricing of ribavirin and other HCV treatments is expected to remain stable due to the high efficacy of current treatments and the lack of significant price erosion driven by generic products in the near future[4].

"The treatment of chronic HCV has undergone a seismic shift during the past few years and HCV can now be considered a curable disease in most patient populations. This success story also translates into higher barriers for companies, as intense competition limits market access while simultaneously the population pool targeted by these drugs is expected to decline in the next decade."[4]

Key Takeaways

• The ribavirin market is expected to grow at a CAGR of 16.40% from 2022 to 2029.
• Key drivers include the increasing incidence of chronic hepatitis C, rising healthcare expenditure, and ongoing clinical trials.
• Challenges include stringent regulatory hurdles, side effects, and the emergence of competing therapies.
• Opportunities exist in research partnerships, technological advancements, and expanding distribution channels.
• The global outlook is influenced by disease prevalence, treatment rates, and pricing dynamics.

FAQs

What is the primary use of ribavirin?

Ribavirin is primarily used in the treatment of chronic hepatitis C, often in combination with other medications like interferons.

What are the key drivers of the ribavirin market?

The key drivers include the increasing incidence of chronic hepatitis C, rising healthcare expenditure, and ongoing clinical trials and research in antiviral drug development.

What are the major challenges facing the ribavirin market?

The major challenges include stringent regulatory hurdles, potential side effects associated with prolonged use, and the emergence of new competing therapies like DAAs.

How is the ribavirin market segmented?

The market is segmented based on type, drug class, demographic, application, dosage form, end-users, and distribution channels.

What is the expected growth rate of the ribavirin market?

The ribavirin market is expected to grow at a CAGR of 16.40% from 2022 to 2029.

Which regions dominate the ribavirin market?

North America currently dominates the market due to the presence of major key players and well-developed healthcare infrastructure, while the Asia-Pacific region is expected to grow significantly in the forecast period.

Sources

1. Global Ribavirin Market - Industry Trends and Forecast to 2029. Data Bridge Market Research.
2. Merck Announces Second Quarter 2011 Financial Results. Merck.
3. Ribavirin Capsules Market Size & Share 2025-2030. 360iResearch.
4. Recent Success in HCV Treatment Brings Relief to Patients but Challenges to Companies. Drug Development.
5. Merck Announces Full-Year and Fourth-Quarter 2011 Financial Results. Merck.