RIBASPHERE Drug Patent Profile

When do Ribasphere patents expire, and what generic alternatives are available?

Ribasphere is a drug marketed by Chartwell Rx and is included in one NDA.

The generic ingredient in RIBASPHERE 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 Ribasphere

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

Summary for RIBASPHERE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	14
DailyMed Link:	RIBASPHERE at DailyMed

Recent Clinical Trials for RIBASPHERE

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

Sponsor	Phase
University of Texas Southwestern Medical Center	Phase 4
Weill Medical College of Cornell University	Phase 4
Memorial Sloan Kettering Cancer Center	Phase 4

See all RIBASPHERE clinical trials

US Patents and Regulatory Information for RIBASPHERE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	RIBASPHERE	ribavirin	CAPSULE;ORAL	076203-001	Apr 6, 2004		DISCN	No	No

EU/EMA Drug Approvals for RIBASPHERE

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	Withdrawn	no	no	no	1999-05-06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	Withdrawn	yes	no	no	2009-07-01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

RIBASPHERE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ribavirin (Ribasphere)

Introduction to Ribavirin

Ribavirin, marketed under the brand name Ribasphere among others, is a nucleoside analogue antiviral drug. It is primarily used in combination with other medications, such as interferons, to treat chronic hepatitis C (HCV) and other viral infections.

Market Growth and Forecast

The global ribavirin market is anticipated to experience significant growth in the forecast period of 2022-2029. According to market analyses, the ribavirin market is expected to grow at a Compound Annual Growth Rate (CAGR) of 16.40% during this period[1].

Key Drivers of Market Growth

Several factors are driving the growth of the ribavirin market:

Increasing Incidence of Chronic Hepatitis C

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

Rising Healthcare Expenditure

Increased healthcare spending globally is another significant factor. Countries with higher disposable incomes and well-developed healthcare infrastructures are more likely to invest in advanced treatments, including ribavirin[1].

Growing Government Initiatives and Awareness

Government initiatives and rising public awareness about HCV and its treatment options also contribute to the market's growth. These initiatives often include public health campaigns and funding for research and treatment programs[1].

Clinical Trials and Research

The ongoing clinical trials and research activities in the field of antiviral drugs are expected to provide new opportunities for the ribavirin market. These trials often lead to the development of new treatment protocols and the expansion of ribavirin's application spectrum[1].

Market Segmentation

The ribavirin market is segmented based on several criteria:

Type

Ribavirin is available in different purity levels, such as 98% and 99% purity[1].

Drug Class

It falls under the categories of inhaled anti-infectives and purine nucleosides[1].

Demographic

The market is segmented into adult and pediatric demographics, reflecting the drug's use across different age groups[1].

Application

Ribavirin is used to treat various conditions, including hemorrhagic fever, renal impairment, thyroid cancer, and most prominently, chronic hepatitis C[1].

Dosage Form

The drug is available in tablet, inhalation solution, and oral solution forms[1].

End-Users

The primary end-users include clinics, hospitals, and other healthcare facilities[1].

Distribution Channel

Ribavirin is distributed through hospital pharmacies, retail pharmacies, and online pharmacies[1].

Geographic Analysis

North America

North America dominates the ribavirin market due to the presence of major pharmaceutical companies, high disposable income, and a well-developed healthcare infrastructure. The U.S. is a key market in this region[1].

Asia-Pacific

The Asia-Pacific region is expected to grow significantly during the forecast period due to increasing research and development activities and rising government support. Countries like China, Japan, and India are crucial in this growth[1].

Financial Trajectory

Revenue and Sales

The financial success of ribavirin is closely tied to the overall HCV treatment market. For instance, the launch of Sovaldi, another HCV treatment drug, led to a significant increase in HCV treatment spending. In 2014, Gilead Sciences reported net product sales of $12.4 billion for its HCV drugs, primarily driven by sales in the U.S. and Europe[2].

Pricing Dynamics

The pricing of ribavirin and other HCV drugs has been a subject of discussion due to their high costs. Despite the effectiveness of these drugs, their prices have led to financial burdens on both public and private healthcare sectors. However, the market dynamics suggest that while price erosion might occur, it is unlikely to continue at the same pace due to regulatory caps and market competition[4].

Market Competition

Ribavirin faces competition from other direct-acting antivirals (DAAs) such as Sovaldi, Harvoni, Daklinza, and Zepatier. Despite this competition, ribavirin remains a significant player due to its established use and combination therapies. Gilead Sciences, the manufacturer of Sovaldi and Harvoni, has maintained a dominant market share, but other companies like Merck and Bristol-Myers Squibb are also making strides in the HCV treatment market[4].

Challenges and Opportunities

Challenges

One of the main challenges facing the ribavirin market is the declining population of diagnosed HCV cases due to the high cure rates of current treatments. This decline threatens the long-term sustainability of HCV drug revenues. Additionally, the market is subject to intense competition and regulatory pressures that can impact pricing and market access[4].

Opportunities

Despite these challenges, there are opportunities for growth. The increasing research and development activities, improving healthcare infrastructure, and growing government support are expected to create new opportunities for the ribavirin market. Moreover, the expansion of ribavirin's application into other diseases, such as thyroid cancer and hemorrhagic fever, could further boost its market potential[1].

Patient Epidemiology and Treatment Impact

Treatment Efficacy

Ribavirin, when used in combination with other drugs like interferons, has significantly improved the treatment outcomes for HCV patients. The new treatment regimens have reduced the treatment duration and increased the cure rates, making HCV a curable disease in most patient populations[2].

Side Effects and Dose Adjustments

However, ribavirin can cause severe side effects, such as anemia, which may necessitate dose adjustments. This highlights the need for careful patient monitoring and management during treatment[1].

Conclusion

The ribavirin market is poised for significant growth driven by increasing HCV cases, rising healthcare expenditure, and ongoing research and development. While the market faces challenges such as competition and declining patient populations, opportunities in new applications and improving healthcare infrastructure are expected to sustain its growth.

Key Takeaways

• The ribavirin market is expected to grow at a CAGR of 16.40% from 2022 to 2029.
• The rise in chronic hepatitis C cases and increasing healthcare expenditure are key drivers.
• The market is segmented by type, drug class, demographic, application, dosage form, end-users, and distribution channel.
• North America and Asia-Pacific are significant regions for market growth.
• The financial trajectory is influenced by the overall HCV treatment market dynamics and competition from other DAAs.
• Challenges include declining patient populations and intense market competition, but opportunities exist in new applications and improving healthcare infrastructure.

FAQs

What is the primary use of ribavirin?

Ribavirin is primarily used in combination with other medications to treat chronic hepatitis C (HCV) and other viral infections.

What is the expected CAGR of the ribavirin market from 2022 to 2029?

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 and Asia-Pacific are the dominant regions for the ribavirin market, with the U.S. and countries like China, Japan, and India being key markets.

What are the main challenges facing the ribavirin market?

The main challenges include the declining population of diagnosed HCV cases, intense market competition, and regulatory pressures.

How does ribavirin impact HCV treatment outcomes?

Ribavirin, when used in combination with other drugs, has significantly improved HCV treatment outcomes by reducing treatment duration and increasing cure rates.

Sources

1. Global Ribavirin Market - Industry Trends and Forecast to 2029. Data Bridge Market Research.
2. THE PRICE OF SOVALDI AND ITS IMPACT ON THE U.S. HEALTH. U.S. Government Publishing Office.
3. A Multi-Billion-Dollar Drug Market. Baron Funds.
4. Recent Success in HCV Treatment Brings Relief to Patients but Challenges to Companies. Drug Development.
5. Investment Trends in Pharmaceutical Research. DrugBank Blog.