VORINOSTAT - Generic Drug Details

What are the generic drug sources for vorinostat and what is the scope of freedom to operate?

Vorinostat is the generic ingredient in one branded drug marketed by Msd Sub Merck and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vorinostat has one hundred and thirty-one patent family members in thirty-five countries.

There are two drug master file entries for vorinostat. One supplier is listed for this compound.

Summary for VORINOSTAT

International Patents:	131
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	280
Patent Applications:	7,387
What excipients (inactive ingredients) are in VORINOSTAT?	VORINOSTAT excipients list
DailyMed Link:	VORINOSTAT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VORINOSTAT

Constraining patent/regulatory exclusivity:

7,456,219

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for VORINOSTAT

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

Sponsor	Phase
Washington State University	Early Phase 1
Lucile Packard Children's Hospital Foundation	Phase 1/Phase 2
Amgen	Phase 1/Phase 2

See all VORINOSTAT clinical trials

Pharmacology for VORINOSTAT

Drug Class	Histone Deacetylase Inhibitor
Mechanism of Action	Histone Deacetylase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for VORINOSTAT

L01XH	Histone deacetylase (HDAC) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for VORINOSTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006		RX	Yes	Yes	7,399,787
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006		RX	Yes	Yes	8,450,372
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006		RX	Yes	Yes	7,851,509		Y

Expired US Patents for VORINOSTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	RE38506
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	6,087,367
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	8,101,663

International Patents for VORINOSTAT

Country	Patent Number	Title	Estimated Expiration
Argentina	055953	FORMULACIONES DE ACIDO HIDROXAMICO SUBEROILANILIDA Y PROCEDIMIENTOS PARA LA PRODUCION DE LAS MISMAS
Norway	328575
Poland	1663194

VORINOSTAT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vorinostat

Introduction

Vorinostat, also known as suberoylanilide hydroxamic acid (SAHA), is a potent histone deacetylase inhibitor that has shown significant promise in the treatment of various cancers, including hematologic and solid tumors. This article delves into the market dynamics and financial trajectory of vorinostat, highlighting key factors, trends, and projections.

Market Overview

The global vorinostat market is segmented by region, type, and application. The market analysis includes sales, revenue, and forecast data from 2016 to 2027, providing a comprehensive view of the market's current state and future prospects[4].

Regional Analysis

The vorinostat market is analyzed across various regions, including North America, Europe, China, Japan, Southeast Asia, India, and other regions. Each region's market size, revenue, and forecast are detailed to help stakeholders understand the geographic distribution of the market[4].

Segment Analysis

The market is segmented by type and application. By type, the market includes different formulations of vorinostat, such as powder and solution. By application, it is segmented into various therapeutic areas, including hematologic malignancies and solid tumors[4].

Market Size and Revenue

The global vorinostat market has been growing steadily, driven by the increasing incidence of cancer and the need for effective treatments. The market size and revenue are expected to continue growing, with a significant compound annual growth rate (CAGR) projected from 2025 to 2031[1].

Historical and Forecasted Data

The base year for market calculations is 2023, with historical data from 2019 to 2023 and forecasted data from 2025 to 2031. This provides a clear picture of the market's past performance and future potential[1].

Key Drivers and Opportunities

Several factors are driving the growth of the vorinostat market:

Increasing Incidence of Cancer

The rising incidence of cancer globally is a major driver, as vorinostat is used in the treatment of various types of cancer, including cutaneous T-cell lymphoma and other hematologic malignancies[3].

Clinical Efficacy

Vorinostat has shown promising clinical activity against both hematologic and solid tumors, making it a valuable treatment option. Its ability to inhibit histone deacetylase and alter cellular acetylation patterns has been well-documented[3].

Combination Therapies

Research on combining vorinostat with other chemotherapeutic agents has opened new avenues for clinical investigation. For example, vorinostat has been shown to improve resistance to oxaliplatin in human colorectal cancer cells[5].

Market Restraints and Challenges

Despite the growth potential, the vorinostat market faces several challenges:

Regulatory Hurdles

Regulatory approvals and compliance can be time-consuming and costly, affecting the market's growth. Different regions have varying regulatory requirements, which can complicate the approval process[1].

Competition

The market for cancer treatments is highly competitive, with numerous other drugs and therapies available. Vorinostat must compete with these alternatives to maintain market share[4].

Side Effects and Toxicity

While vorinostat is generally well-tolerated, it can have side effects, which may impact patient compliance and overall market growth[3].

Competitive Analysis

The vorinostat market is characterized by a competitive landscape with several key players. These companies are involved in ongoing research and development to enhance the efficacy and safety of vorinostat. Competitive analysis includes market share, product portfolios, and strategic initiatives of these players[1].

Regional Dominance

North America and Europe are expected to dominate the global vorinostat market within the forecast period, driven by advanced healthcare infrastructure, high incidence of cancer, and strong research and development activities in these regions[4].

Technological Trends

Technological advancements in the field of histone deacetylase inhibitors are continuously evolving. Research on new mechanisms of action and combination therapies is expected to drive innovation in the vorinostat market[3].

HDAC Inhibition

The mechanism of action of vorinostat involves the inhibition of histone deacetylase, which alters cellular acetylation patterns. This technology has the potential to be applied in various therapeutic areas beyond cancer, such as neurodegenerative diseases[3].

Financial Projections

The financial trajectory of the vorinostat market is positive, with significant revenue growth anticipated. Here are some key financial projections:

CAGR

The market is expected to grow at a substantial CAGR from 2025 to 2031, driven by increasing demand and expanding therapeutic applications[1].

Revenue Forecast

The revenue forecast indicates a steady increase, reflecting the market's potential for growth. This growth is supported by the increasing adoption of vorinostat in clinical settings and ongoing research into new applications[1].

Market Attractiveness

The vorinostat market is attractive due to its potential for high returns on investment. The market's attractiveness is analyzed using tools like Porter's Five Forces and PESTEL analysis, which provide insights into the competitive environment and external factors influencing the market[1].

Consumer Behavior Analysis

Consumer behavior, particularly patient preferences and compliance, plays a crucial role in the market's growth. Studies on cognitive function and quality of life in vorinostat-treated patients highlight the importance of patient-centered care and the need for therapies that improve both survival and quality of life[2].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the vorinostat market. While it disrupted supply chains and clinical trials, it also accelerated the need for effective cancer treatments, potentially boosting demand for vorinostat[1].

Key Takeaways

• Growing Market: The global vorinostat market is expected to grow significantly, driven by increasing cancer incidence and the drug's clinical efficacy.
• Regional Dominance: North America and Europe are projected to dominate the market due to advanced healthcare infrastructure and high cancer incidence.
• Technological Advancements: Ongoing research into new mechanisms of action and combination therapies is driving innovation in the market.
• Competitive Landscape: The market is competitive, with several key players involved in R&D to enhance vorinostat's efficacy and safety.
• Financial Projections: The market is anticipated to grow at a substantial CAGR, with significant revenue growth expected from 2025 to 2031.

FAQs

What is Vorinostat?

Vorinostat, or suberoylanilide hydroxamic acid (SAHA), is a histone deacetylase inhibitor used in the treatment of various cancers, including hematologic and solid tumors.

What are the key drivers of the Vorinostat market?

Key drivers include the increasing incidence of cancer, clinical efficacy of vorinostat, and research into combination therapies.

Which regions are expected to dominate the Vorinostat market?

North America and Europe are expected to dominate the global vorinostat market due to advanced healthcare infrastructure and high cancer incidence.

What are the potential side effects of Vorinostat?

While generally well-tolerated, vorinostat can have side effects that may impact patient compliance and overall market growth.

How has the COVID-19 pandemic impacted the Vorinostat market?

The pandemic has had a mixed impact, disrupting supply chains and clinical trials but also accelerating the need for effective cancer treatments.

References

1. Vorinostat Market Report 2024 (Global Edition) - Cognitivemarketresearch.com
2. Cognitive Function and Quality of Life in Vorinostat-Treated Patients - ScienceDirect
3. Development of vorinostat: current applications and future - PubMed
4. Global Vorinostat Sales Market Report 2021 - Valuates.com
5. Improvement of resistance to oxaliplatin by vorinostat in human colorectal cancer cells - ScienceDirect