Peginterferon alfa-2b - Biologic Drug Details

Summary for peginterferon alfa-2b

Tradenames:	2
High Confidence Patents:	16
Applicants:	2
BLAs:	2
Recent Clinical Trials:	See clinical trials for peginterferon alfa-2b
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for peginterferon alfa-2b

Recent Clinical Trials for peginterferon alfa-2b

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Shanghai Institute Of Biological Products	Phase 2
Chinese Academy of Medical Sciences Dermatology Hospital	Phase 2
Eiger BioPharmaceuticals	Phase 3

See all peginterferon alfa-2b clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for peginterferon alfa-2b Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for peginterferon alfa-2b Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	5,395,760	2012-03-07	Company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	5,605,690	2014-02-25	Company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	5,618,698	2003-12-13	Company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	5,908,621	2015-11-02	Company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	5,945,397	2009-09-11	Company disclosures
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	5,951,974	2013-11-10	Company disclosures

3) Low Certainty: US Patents for peginterferon alfa-2b Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,383,876	2031-04-05	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,577,154	2029-05-13	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,596,173	2038-05-03	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,626,100	2033-12-23	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,656,152	2029-01-29	Patent claims search
Merck Sharp & Dohme Llc	PEGINTRON	peginterferon alfa-2b	Injection	103949	10,844,066	2037-03-01	Patent claims search

International Patents for peginterferon alfa-2b

Country	Patent Number	Estimated Expiration
Norway	941780
Norway	812247
South Korea	100232688
Spain	2197149
Mexico	9803448
World Intellectual Property Organization (WIPO)	9513090

Supplementary Protection Certificates for peginterferon alfa-2b

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C300008	Netherlands		PRODUCT: ETANERCEPTUM
0090011-8, 0091011-7	Sweden		NATIONAL REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI 55365 20000201
15/2000	Austria		PRODUCT NAME: ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI 55365 20000201
SZ 15/2000	Austria		PRODUCT NAME: ETANERCEPT
132000900852970	Italy
00C0015	France		PRODUCT NAME: ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI - IKS- N 55365 20000201

Market Dynamics and Financial Trajectory for Peginterferon Alfa-2b

Introduction

Peginterferon alfa-2b is a biologic drug used primarily in the treatment of chronic hepatitis C (CHC) and other conditions such as malignant melanoma. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare professionals.

Historical Market Uptake

Early Adoption and Regional Variations

The market uptake of peginterferon alfa-2b varied significantly across Europe. Countries that were part of the EU founder states showed the earliest, most rapid, and highest adoption rates, followed by newer EU member states and non-member states. By the end of 2005, approximately 308,000 patients had been treated with peginterferons in 21 evaluated countries, with significant disparities in treatment rates between countries like France and those such as Romania, Poland, Greece, and Russia[1].

Clinical Indications and Treatment Regimens

Hepatitis C Treatment

Peginterferon alfa-2b is commonly used in combination with ribavirin for the treatment of CHC. This combination is indicated for patients with various genotypes of HCV, particularly those where the use of an HCV NS3/4A protease inhibitor is not warranted due to tolerability issues or contraindications[4].

Other Indications

Besides CHC, peginterferon alfa-2b is also used to prevent the recurrence of malignant melanoma after surgical removal and in the treatment of certain other conditions[2].

Safety and Efficacy Considerations

Adverse Effects

The treatment with peginterferon alfa-2b, especially when combined with ribavirin, is associated with several adverse effects, including neuropsychiatric disorders, autoimmune reactions, and hematologic abnormalities. These side effects can significantly impact the quality of life and necessitate careful monitoring[4].

Monitoring and Precautions

Patients undergoing treatment with peginterferon alfa-2b require regular blood tests and, in some cases, electrocardiograms to monitor potential adverse effects. This rigorous monitoring adds to the overall cost and complexity of the treatment regimen[2].

Financial Performance and Market Trends

Revenue and Sales

In the early 2000s, peginterferon alfa-2b was a significant revenue generator for pharmaceutical companies. However, with the advent of newer, more effective treatments for HCV, such as direct-acting antivirals (DAAs), the demand for peginterferon alfa-2b has declined. For instance, Merck voluntarily discontinued the manufacture of PEGINTRON REDIPEN in the United States due to reduced demand and advancements in treatment practices[4].

Impact of New Therapies

The introduction of DAAs has revolutionized the treatment of HCV, offering higher cure rates and fewer side effects compared to interferon-based therapies. This shift has led to a decline in the sales of peginterferon alfa-2b, as seen in the financial reports of companies like Gilead Sciences, which have reported increased sales of their newer HCV products while older therapies like peginterferon alfa-2b have seen a decline[3].

Regional and Global Market Dynamics

Access and Affordability

Access to peginterferon alfa-2b has been unequal across different regions, largely due to budget restrictions and national healthcare policies. In many countries, especially those with lower economic resources, the availability and affordability of this treatment have been significant challenges[1].

Regulatory Environment

Regulatory changes and approvals also play a crucial role in the market dynamics of peginterferon alfa-2b. For example, the discontinuation of certain formulations like PEGINTRON REDIPEN was a business decision influenced by changing treatment practices and regulatory considerations[4].

Financial Projections and Future Outlook

Declining Revenue

Given the advent of more effective and safer treatments for HCV, the revenue from peginterferon alfa-2b is expected to continue declining. Pharmaceutical companies are shifting their focus towards newer therapies that offer better outcomes and fewer side effects.

Diversification of Portfolios

Companies like Gilead Sciences are diversifying their portfolios to include a range of treatments beyond HCV, such as HIV therapies and other virology products. This diversification helps mitigate the impact of declining sales in specific therapeutic areas[3].

Key Takeaways

• Market Uptake Variability: The adoption of peginterferon alfa-2b has varied significantly across different regions and countries.
• Clinical Indications: The drug is used primarily for CHC and malignant melanoma, with specific treatment regimens and monitoring requirements.
• Safety and Efficacy: The treatment is associated with several adverse effects, necessitating careful patient monitoring.
• Financial Performance: The revenue from peginterferon alfa-2b has declined with the introduction of newer, more effective HCV treatments.
• Regulatory and Access Issues: Access to the drug has been influenced by budget restrictions and national healthcare policies.

FAQs

What is peginterferon alfa-2b used for?

Peginterferon alfa-2b is used primarily for the treatment of chronic hepatitis C (CHC) and to prevent the recurrence of malignant melanoma after surgical removal.

Why has the demand for peginterferon alfa-2b declined?

The demand has declined due to the introduction of more effective and safer direct-acting antivirals (DAAs) for the treatment of HCV.

What are the common side effects of peginterferon alfa-2b?

Common side effects include neuropsychiatric disorders, autoimmune reactions, and hematologic abnormalities.

Why was PEGINTRON REDIPEN discontinued?

PEGINTRON REDIPEN was discontinued due to reduced demand and advancements in treatment practices, not due to any safety or efficacy concerns.

How has the market uptake of peginterferon alfa-2b varied across regions?

The market uptake has varied significantly, with higher adoption rates in EU founder states and lower rates in newer EU member states and non-member states.

Sources

1. Market uptake of new antiviral drugs for the treatment of hepatitis C - PubMed
2. Peginterferon alfa-2b (subcutaneous route) - Mayo Clinic
3. Gilead Sciences Announces Second Quarter 2021 Financial Results - Business Wire
4. Dear Health Care Professional Letter: Pegintron Redipen - FDA
5. The clinical effectiveness and cost-effectiveness of peginterferon alfa and ribavirin for the treatment of chronic hepatitis C in children and young people - NCBI Books

Last updated: 2024-12-16