GENESA Drug Patent Profile

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

Genesa is a drug marketed by Gensia Automedics and is included in one NDA.

The generic ingredient in GENESA is arbutamine hydrochloride. There is one drug master file entry for this compound. Additional details are available on the arbutamine hydrochloride profile page.

Summary for GENESA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	11
Patent Applications:	259
DailyMed Link:	GENESA at DailyMed

US Patents and Regulatory Information for GENESA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gensia Automedics	GENESA	arbutamine hydrochloride	INJECTABLE;INJECTION	020420-001	Sep 12, 1997		DISCN	No	No

Expired US Patents for GENESA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gensia Automedics	GENESA	arbutamine hydrochloride	INJECTABLE;INJECTION	020420-001	Sep 12, 1997	5,108,363
Gensia Automedics	GENESA	arbutamine hydrochloride	INJECTABLE;INJECTION	020420-001	Sep 12, 1997	5,234,404
Gensia Automedics	GENESA	arbutamine hydrochloride	INJECTABLE;INJECTION	020420-001	Sep 12, 1997	5,395,970

International Patents for GENESA

See the table below for patents covering GENESA around the world.

Country	Patent Number	Title	Estimated Expiration
Greece	3018764
European Patent Office	0658538	La diagnose, l'évaluation et le traitement de la maladie de l'artère coronaire par simulation de l'exercice par l'utilisation de la livraison de boucle fermée des dragues d'un agent bêta agoniste qui simule l'exercice (Diagnosis, evaluation and treatment of coronary artery disease by exercise simulation using closed loop drug delivery of an exercise simulating agent beta agonist)
New Zealand	239270	1-(3,4-DIHYDROXYPHENYL)-2-(4-(4-HYDROXYPHENYL) BUTYLAMINO) ETHANOL AND ACID-ADDITION SALTS THEREOF
Austria	159710

GENESA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Epigenetic Drugs and Diagnostic Technologies: A Comprehensive Overview

Introduction

The field of epigenetics, which involves the study of heritable changes in gene function that occur without a change in the underlying DNA sequence, has been gaining significant traction in recent years. This growth is driven by the increasing understanding of epigenetic mechanisms and their role in various diseases, including cancer, neurological disorders, and metabolic diseases. Here, we will delve into the market dynamics and financial trajectory of epigenetic drugs and diagnostic technologies, highlighting key trends, drivers, and future outlook.

Market Size and Growth

The global epigenetics drugs and diagnostic technologies market was valued at USD 15.4 billion in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 14.5% from 2024 to 2030[1].

Segmentation and Dominance

Diagnostics vs. Drugs

Diagnostics products and services dominate the market, accounting for 94.9% of the revenue share in 2023. This dominance is attributed to the increasing prevalence of chronic diseases and cancer, advancements in technology, and a rising geriatric population[1].

Diagnostic Technology Segments

Diagnostic technology is further categorized into reagents, kits, instruments, enzymes, and services. Reagents are expected to maintain their dominance due to their crucial role in advancing epigenetic diagnostics and studying gene expression[1].

Geographical Analysis

North America

North America leads the global market, accounting for 41.5% of the revenue share in 2023. The U.S. is the largest contributor within North America, driven by the presence of major pharmaceutical companies, academic institutions, and favorable reimbursement policies[1].

Asia Pacific

The Asia Pacific region is anticipated to grow at a CAGR of 15.7% over the forecast period. Countries like China and India are driving this growth due to increased awareness of diseases, early diagnosis initiatives, and government funding for research projects[1].

Europe

Europe is also expected to see significant growth, led by Germany, where there is a high prevalence of cancer and other chronic diseases, along with a rising geriatric population and advanced healthcare infrastructure[1].

Drivers of Growth

Lifestyle-Related Disorders

The rise in lifestyle-related disorders such as diabetes and obesity is a key driver. Epigenetic changes are linked to these conditions, making epigenetic diagnostics and therapies increasingly relevant[1].

Chronic and Neurodegenerative Diseases

Chronic disorders, including central nervous system (CNS) diseases, and neurodegenerative diseases like Alzheimer’s and Parkinson’s, are also driving the market. Epigenetic changes are at the base of many non-oncological disorders, fueling the growth in this segment[1].

Technological Advancements

Advancements in technology, particularly in reagents and diagnostic tools, are enhancing the capabilities of epigenetic diagnostics. This innovation is crucial for personalized medicine and studying gene expression[1].

Financial Trajectory

Revenue Projections

The market is expected to see substantial revenue growth, with diagnostics continuing to dominate. The drugs segment, including Histone Deacetylase (HDAC) and DNA Methyltransferase (DNMT) inhibitors, is projected to grow at a CAGR of 10.9% over the forecast period[1].

Investment and Funding

Strategic collaborations among companies, academic institutions, and regulatory bodies are boosting innovation and product development. Organizations like the International Human Epigenome Consortium (IHEC), the National Cancer Institute (NCI), and the National Institute of Health (NIH) are providing significant funding for research and development in this field[1].

Non-Oncology Applications

Non-oncology applications are expected to grow at a CAGR of 15.5% over the projected years. This growth is driven by stringent R&D programs and the increasing use of epigenetics in treating metabolic disorders, neurodegenerative diseases, and infectious diseases[1].

Industry Dynamics and Competition

Generic Drug Industry Insights

While the epigenetics market is distinct, insights from the generic drug industry can provide context. Generic drug prices decline with the number of competitors, approaching long-run marginal costs when there are 8 or more competitors. This dynamic highlights the importance of competition in driving down costs and increasing accessibility[3].

Consolidation and R&D Spending

In the broader drug industry, consolidation among companies can reduce competition and R&D investment. However, in the epigenetics sector, collaborations and funding initiatives are driving innovation rather than hindering it[4].

Regulatory Flexibility and Rare Diseases

For ultra-rare therapies, regulatory flexibility is crucial. The need for regulators to exercise their flexibility in approving and funding research for rare diseases is highlighted in recent reports, which could have implications for the epigenetics market as it expands into rare disease treatments[5].

Key Takeaways

• The global epigenetics drugs and diagnostic technologies market is projected to grow significantly, driven by lifestyle-related disorders, chronic diseases, and technological advancements.
• Diagnostics dominate the market, with reagents playing a critical role.
• North America, particularly the U.S., leads the market, followed by Asia Pacific and Europe.
• Non-oncology applications are growing rapidly, driven by R&D programs and the increasing use of epigenetics in various diseases.
• Strategic collaborations and funding are key drivers of innovation in this field.

FAQs

What is the current market size of the epigenetics drugs and diagnostic technologies market?

The global epigenetics drugs and diagnostic technologies market was valued at USD 15.4 billion in 2023[1].

Which region dominates the epigenetics drugs and diagnostic technologies market?

North America, particularly the U.S., dominates the global market, accounting for 41.5% of the revenue share in 2023[1].

What are the key drivers of growth in the epigenetics market?

Key drivers include lifestyle-related disorders, chronic and neurodegenerative diseases, and technological advancements in diagnostics and personalized medicine[1].

How is the non-oncology segment expected to grow?

The non-oncology segment is expected to grow at a CAGR of 15.5% over the projected years, driven by R&D programs and the increasing use of epigenetics in treating various diseases[1].

What role do reagents play in the epigenetics diagnostics market?

Reagents are expected to maintain their dominance due to their crucial role in advancing epigenetic diagnostics and studying gene expression[1].

Cited Sources:

1. Grand View Research: Epigenetics Drugs & Diagnostic Technologies Market Report 2030.
2. Ultragenyx Pharmaceutical Inc.: First Quarter 2024 Financial Results and Clinical Milestones.
3. Federal Trade Commission: Generic Drug Industry Dynamics.
4. United States Government Accountability Office: DRUG INDUSTRY: Profits, Research and Development Spending, and Merger and Acquisition Deals.
5. Global Genes: The need for regulators to exercise their flexibility to address ultra-rare therapies.