SYLATRON Drug Profile

Summary for Tradename: SYLATRON

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for SYLATRON

Recent Clinical Trials for SYLATRON

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Hoosier Cancer Research Network	Phase 2
Roswell Park Cancer Institute	Phase 2
Georgetown University	Phase 2

See all SYLATRON 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 SYLATRON Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for SYLATRON 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	SYLATRON	peginterferon alfa-2b	For Injection	103949		2012-03-07	Company disclosures
Merck Sharp & Dohme Llc	SYLATRON	peginterferon alfa-2b	For Injection	103949		2014-02-25	Company disclosures
Merck Sharp & Dohme Llc	SYLATRON	peginterferon alfa-2b	For Injection	103949		2003-12-13	Company disclosures
Merck Sharp & Dohme Llc	SYLATRON	peginterferon alfa-2b	For Injection	103949		2015-11-02	Company disclosures

3) Low Certainty: US Patents for SYLATRON 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	SYLATRON	peginterferon alfa-2b	For Injection	103949		2031-04-05	Patent claims search
Merck Sharp & Dohme Llc	SYLATRON	peginterferon alfa-2b	For Injection	103949		2029-05-13	Patent claims search
Merck Sharp & Dohme Llc	SYLATRON	peginterferon alfa-2b	For Injection	103949		2038-05-03	Patent claims search
Merck Sharp & Dohme Llc	SYLATRON	peginterferon alfa-2b	For Injection	103949		2033-12-23	Patent claims search

International Patents for SYLATRON

Country	Patent Number	Estimated Expiration
Australia	7246281
Canada	2123593
Singapore	71179
Australia	630497

Supplementary Protection Certificates for SYLATRON

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 15/2000	Austria		PRODUCT NAME: ETANERCEPT
SPC/GB00/015	United Kingdom		PRODUCT NAME: ETANERCEPT; REGISTERED: CH 55365 20000201; UK EU/1/99/126/001 20000203
C300008	Netherlands		PRODUCT: ETANERCEPTUM
15/2000	Austria		PRODUCT NAME: ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI 55365 20000201

SYLATRON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: SYLATRON

Introduction

SYLATRON, also known as peginterferon alfa-2b, is a biologic drug developed by Merck & Co., Inc. It is used primarily for the treatment of chronic hepatitis C and as an adjuvant treatment for malignant melanoma. Understanding the market dynamics and financial trajectory of SYLATRON involves analyzing various factors, including market competition, regulatory environment, patient demand, and financial performance.

Market Competition

The biologic drugs market, particularly for hepatitis C and melanoma treatments, is highly competitive. SYLATRON competes with other biologic molecules and small molecule drugs in these therapeutic areas. For hepatitis C, competitors include drugs like Sovaldi (sofosbuvir) from Gilead Sciences, which has dominated the market due to its high efficacy and patient preference[2].

In the melanoma treatment segment, SYLATRON faces competition from immunotherapeutic agents such as pembrolizumab (Keytruda) and ipilimumab (Yervoy), also from Merck & Co., Inc. and Bristol Myers Squibb, respectively. These newer therapies have shown significant improvements in patient outcomes, making them preferred choices over traditional interferon-based treatments like SYLATRON[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of biologic drugs. SYLATRON has been approved by regulatory bodies such as the FDA for its indicated uses. However, the approval of newer, more effective treatments can impact the market share of existing drugs. For instance, the approval of checkpoint inhibitors like Keytruda has significantly altered the treatment landscape for melanoma, reducing the reliance on interferon-based therapies[4].

Patient Demand and Treatment Trends

Patient demand is influenced by the efficacy, safety, and convenience of treatments. SYLATRON, being an interferon-based therapy, often requires frequent injections and can have significant side effects, which may deter some patients. In contrast, newer therapies like kinase inhibitors and immunotherapies offer better tolerability and higher response rates, leading to a shift in patient and physician preferences[4].

Financial Performance

The financial performance of SYLATRON is tied to its sales and market share. While Merck & Co., Inc. does not release detailed financial data specifically for SYLATRON, the overall revenue from its biologic portfolio can provide insights.

Merck & Co., Inc. has seen significant revenue from its biologic and vaccine products, including those in the oncology and infectious diseases segments. However, the revenue from SYLATRON has likely been impacted by the rise of more effective and better-tolerated treatments. For example, Keytruda, another Merck product, has become a blockbuster drug with billions of dollars in annual sales, overshadowing the revenue from SYLATRON[1].

Revenue Trends

Historically, SYLATRON generated substantial revenue, particularly in the early 2000s and 2010s when it was one of the few treatment options available for hepatitis C and melanoma. However, with the advent of newer therapies, its sales have declined. The exact financial figures for SYLATRON are not publicly disclosed, but the trend is clear: newer, more effective treatments have captured a larger share of the market.

Impact of Newer Therapies

The introduction of drugs like Sovaldi and Keytruda has dramatically changed the treatment landscape. Sovaldi, for instance, generated $7.9 billion in U.S. sales in 2014 alone, dominating the hepatitis C market and reducing the demand for older treatments like SYLATRON[2].

Market Forecast

The market forecast for SYLATRON is not optimistic due to the competitive landscape. As more innovative and effective treatments become available, the demand for SYLATRON is expected to continue declining.

Submarket Analysis

In the melanoma treatment market, immunotherapeutic drugs are expected to continue their dominance. The global melanoma drugs market, which includes chemotherapeutic, kinase inhibitors, and immunotherapeutic drugs, is forecasted to grow, but SYLATRON's share in this market is likely to diminish[4].

Geographic Analysis

Geographically, the demand for SYLATRON may vary, but overall, the trend of declining sales is expected to persist across major markets, including North America, Europe, and Asia. Emerging markets may still see some demand due to cost considerations, but even there, the preference is shifting towards newer therapies[4].

Key Takeaways

• Competitive Landscape: SYLATRON faces intense competition from newer, more effective biologic and small molecule drugs.
• Regulatory Environment: Approvals of newer treatments have altered the market dynamics, reducing SYLATRON's market share.
• Patient Demand: Patients and physicians prefer newer therapies with better efficacy and tolerability.
• Financial Performance: Revenue from SYLATRON has declined with the rise of more effective treatments.
• Market Forecast: The demand for SYLATRON is expected to continue declining as newer treatments dominate the market.

FAQs

What is SYLATRON used for?

SYLATRON, or peginterferon alfa-2b, is used for the treatment of chronic hepatitis C and as an adjuvant treatment for malignant melanoma.

How does SYLATRON compare to newer treatments?

SYLATRON is less effective and has more side effects compared to newer treatments like Sovaldi for hepatitis C and Keytruda for melanoma.

What is the current market trend for SYLATRON?

The demand for SYLATRON is declining due to the availability of more effective and better-tolerated treatments.

How does the regulatory environment impact SYLATRON?

The approval of newer treatments has reduced the market share of SYLATRON, as regulatory bodies and healthcare providers prefer more effective therapies.

What is the financial outlook for SYLATRON?

The financial outlook for SYLATRON is not optimistic, with declining sales expected due to the rise of more effective treatments.

Sources

1. Top 5 Vendors in the Cancer Biologics Market from 2019 to 2023 - Technavio
2. The Price of Sovaldi and Its Impact on the U.S. Health - U.S. Government Publishing Office
3. Ligand Reports Second Quarter 2024 Financial Results - Ligand Pharmaceuticals
4. Global Melanoma Drugs Market 2018-2028 - PR Newswire