COPEGUS Drug Patent Profile

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

Copegus is a drug marketed by Roche and is included in one NDA.

The generic ingredient in COPEGUS 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 Copegus

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

Summary for COPEGUS

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	160
DailyMed Link:	COPEGUS at DailyMed

Recent Clinical Trials for COPEGUS

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

Sponsor	Phase
Weill Medical College of Cornell University	Early Phase 1
Memorial Sloan Kettering Cancer Center	Early Phase 1
National Cancer Institute (NCI)	Phase 1/Phase 2

See all COPEGUS clinical trials

US Patents and Regulatory Information for COPEGUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche	COPEGUS	ribavirin	TABLET;ORAL	021511-001	Dec 3, 2002		DISCN	Yes	No
Roche	COPEGUS	ribavirin	TABLET;ORAL	021511-002	Jun 21, 2005		DISCN	Yes	No

EU/EMA Drug Approvals for COPEGUS

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	Withdrawn	no	no	no	1999-05-06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

COPEGUS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: COPEGUS

Introduction

COPEGUS, also known as ribavirin, is a crucial antiviral medication used in the treatment of chronic hepatitis C, often in combination with other drugs. Understanding the market dynamics and financial trajectory of COPEGUS is essential for both pharmaceutical companies and healthcare providers.

Market Overview

The global ribavirin market, which includes COPEGUS, is expected to grow significantly over the coming years. Here are some key points that outline the market's current state and future projections:

Growth Drivers

• The rise in the incidence of chronic hepatitis C globally is a major factor driving the market growth of ribavirin[4].
• Increasing healthcare expenditure and government initiatives also contribute to the market's expansion[4].
• The demand from various end-use industries, such as hospitals and clinics, further fuels the market growth.

Market Size and Forecast

The ribavirin market, including COPEGUS, is projected to grow at a Compound Annual Growth Rate (CAGR) of 16.40% from 2022 to 2029[4].

Competitive Landscape

The hepatitis C treatment market is highly competitive, with several major pharmaceutical companies vying for market share.

Key Players

• Gilead Sciences, with its dominant position through drugs like Sovaldi and Harvoni, has been a significant player in the HCV treatment market. However, other companies like Bristol-Myers Squibb (BMS) and Merck are also present with their own DAA regimens[1].
• The competitive landscape is further intensified by the presence of other drugs like Daklinza (daclatasvir) and Olysio (simeprevir), which are often used in combination with ribavirin[1].

Market Share and Pricing

• Despite the efficacy of COPEGUS and other ribavirin-based treatments, the market share of these drugs is influenced by the pricing strategies of dominant players like Gilead. The wholesale acquisition cost (WAC) of Sovaldi and Harvoni, for example, has been significantly higher than that of newer entrants like Merck’s Zepatier, which is priced at $54,000 per treatment[1].
• However, the actual revenue per treatment for these drugs is often lower due to significant discounts negotiated by insurers and health plans[1].

Financial Burden and Pricing Pressures

The financial aspect of HCV treatments, including COPEGUS, is complex and subject to various pressures.

Pricing Dynamics

• The list prices of HCV drugs, including COPEGUS when used in combination therapies, are high. For instance, Sovaldi’s WAC is $84,000 for a 12-week treatment, but the average revenue per treatment is significantly lower due to discounts[1].
• The launch of new pan-genotypic drugs is expected to maintain or even increase prices due to their premium positioning and the lack of generic competition in the near future[1].

Cost-Effectiveness and Reimbursement

• Studies have shown that sofosbuvir-based therapies, which often include ribavirin, are cost-effective for a significant portion of patients. For example, one analysis indicated that these therapies were cost-effective in 83% of treatment-naive and 81% of treatment-experienced patients when a willingness-to-pay threshold was set at $100,000[3].
• However, the overall financial burden on the healthcare system remains high. The approval of new HCV drugs has led to increased federal spending, such as in Medicare Part D, which saw an estimated increase from $2.9 billion to $5.8 billion in 2015[3].

Clinical and Safety Considerations

The use of COPEGUS is not without clinical and safety considerations that can impact its market dynamics.

Side Effects and Monitoring

• COPEGUS can cause severe side effects such as hemolytic anemia, hepatic failure, and severe hypersensitivity reactions. Patients must be closely monitored, and dose adjustments or discontinuation may be necessary[5].
• These safety concerns can affect patient adherence and overall treatment outcomes, which in turn can influence market demand.

Combination Therapies

• COPEGUS is often used in combination with other drugs like peginterferon alfa-2a or peginterferon alpha-2b. The efficacy and safety of these combination therapies are critical factors in their market acceptance[4].

Global Outlook

The global outlook for COPEGUS and the broader HCV treatment market is shaped by several factors.

Disease Prevalence and Treatment Rates

• The high treatment rates in many countries, combined with low incidence rates and high Sustained Virologic Response (SVR) rates achieved by current DAA treatments, are leading to a decline in the patient population seeking treatment. This trend affects the long-term revenue sustainability for HCV drugs[1].

Regulatory and Market Caps

• In some countries, regulatory measures such as annual spending caps (e.g., €0.7 billion in France) can limit the revenue growth for HCV treatments, even if more patients are treated[1].

Key Takeaways

• Market Growth: The ribavirin market, including COPEGUS, is expected to grow at a CAGR of 16.40% from 2022 to 2029.
• Competitive Landscape: The market is highly competitive, with Gilead Sciences dominating but facing challenges from other players like Merck and BMS.
• Pricing Dynamics: High list prices but significant discounts negotiated by insurers; new pan-genotypic drugs are likely to be priced at a premium.
• Clinical and Safety Considerations: COPEGUS has significant side effects that require careful monitoring and dose adjustments.
• Global Outlook: Declining patient population due to high treatment rates and low incidence rates; regulatory caps in some countries limit revenue growth.

FAQs

Q: What is the projected growth rate of the ribavirin market, including COPEGUS?

A: The ribavirin market is projected to grow at a CAGR of 16.40% from 2022 to 2029[4].

Q: How does the pricing of COPEGUS compare to other HCV treatments?

A: While COPEGUS is often used in combination therapies with high list prices, actual revenue per treatment is lower due to significant discounts negotiated by insurers[1].

Q: What are the major side effects of COPEGUS that need to be monitored?

A: COPEGUS can cause severe side effects such as hemolytic anemia, hepatic failure, and severe hypersensitivity reactions, requiring close monitoring and potential dose adjustments[5].

Q: How does the competitive landscape affect the market share of COPEGUS?

A: The competitive landscape, dominated by Gilead Sciences but with significant presence from other companies like Merck and BMS, influences the market share of COPEGUS through pricing strategies and treatment algorithms[1].

Q: What impact do regulatory measures have on the revenue growth of HCV treatments like COPEGUS?

A: Regulatory measures such as annual spending caps can limit the revenue growth for HCV treatments, even if more patients are treated[1].

Sources

1. Recent Success in HCV Treatment Brings Relief to Patients but Challenges to Companies - Drug Development.
2. U.S. Food and Drug Administration Approves Gilead's Sovaldi (Sofosbuvir) for the Treatment of Chronic Hepatitis C - Gilead.
3. Pricing Pressures: How the Business of Medicine Affects the Price of Therapy - Healio.
4. Global Ribavirin Market - Industry Trends and Forecast to 2029 - Data Bridge Market Research.
5. Copegus (ribavirin) tablets label - FDA.