Romidepsin - Generic Drug Details

What are the generic sources for romidepsin and what is the scope of patent protection?

Romidepsin is the generic ingredient in two branded drugs marketed by Bristol-myers, Fresenius Kabi Usa, and Teva Pharms Usa Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for romidepsin. Three suppliers are listed for this compound.

Summary for romidepsin

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	100
Patent Applications:	6,714
Drug Prices:	Drug price trends for romidepsin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for romidepsin
What excipients (inactive ingredients) are in romidepsin?	romidepsin excipients list
DailyMed Link:	romidepsin at DailyMed

See drug prices for romidepsin

Recent Clinical Trials for romidepsin

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

Sponsor	Phase
Peking Union Medical College Hospital	Phase 1/Phase 2
INSERM SC10-US19	Phase 1
ANRS, Emerging Infectious Diseases	Phase 1

See all romidepsin clinical trials

Pharmacology for romidepsin

Drug Class	Histone Deacetylase Inhibitor
Mechanism of Action	Bile Salt Export Pump Inhibitors Histone Deacetylase Inhibitors Organic Anion Transporter 1 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for romidepsin

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

Paragraph IV (Patent) Challenges for ROMIDEPSIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ISTODAX	Injection	romidepsin	10 mg/vial	022393	1	2013-11-05

US Patents and Regulatory Information for romidepsin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa Inc	ROMIDEPSIN	romidepsin	SOLUTION;INTRAVENOUS	208574-002	Mar 13, 2020		DISCN	Yes	No
Bristol-myers	ISTODAX	romidepsin	POWDER;INTRAVENOUS	022393-001	Nov 5, 2009	AP	RX	Yes	Yes
Teva Pharms Usa Inc	ROMIDEPSIN	romidepsin	SOLUTION;INTRAVENOUS	208574-001	Mar 13, 2020		DISCN	Yes	No
Fresenius Kabi Usa	ROMIDEPSIN	romidepsin	POWDER;INTRAVENOUS	206254-001	Oct 12, 2021	AP	RX	No	No

Expired US Patents for romidepsin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol-myers	ISTODAX	romidepsin	POWDER;INTRAVENOUS	022393-001	Nov 5, 2009	4,977,138
Bristol-myers	ISTODAX	romidepsin	POWDER;INTRAVENOUS	022393-001	Nov 5, 2009	7,611,724
Bristol-myers	ISTODAX	romidepsin	POWDER;INTRAVENOUS	022393-001	Nov 5, 2009	7,608,280

EU/EMA Drug Approvals for romidepsin

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Celgene Europe Ltd.	Istodax	romidepsin	EMEA/H/C/002122 treatment of peripheral T-cell lymphoma (PTCL),	Refused	no	no	yes		2013-02-12

Romidepsin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Romidepsin

Introduction

Romidepsin, a histone deacetylase inhibitor, has been gaining significant traction in the pharmaceutical market, particularly in the treatment of T-cell lymphomas. Here, we delve into the market dynamics and financial trajectory of Romidepsin, exploring its current state, growth drivers, and future prospects.

Market Size and Growth Projections

The Romidepsin market is anticipated to experience robust growth in the coming years. As of 2024, the market is valued at USD 8.65 billion and is projected to reach USD 17.73 billion by 2031, reflecting a compound annual growth rate (CAGR) of 10.79%[1].

Key Drivers of Market Growth

Several factors are driving the growth of the Romidepsin market:

Increasing Adoption in T-cell Lymphomas

Romidepsin has shown promising results in treating cutaneous and peripheral T-cell lymphomas, especially in patients who have not responded to other treatments. This efficacy has led to increased adoption and demand for the drug[1].

Ongoing Research and Development

Continuous research and development activities are aimed at expanding the therapeutic applications of Romidepsin beyond T-cell lymphomas. This ongoing innovation is expected to further boost its market growth[1].

Regulatory Approval

The approval of Romidepsin by regulatory bodies such as the FDA has enhanced its credibility and acceptance among healthcare providers. This regulatory support is a significant driver of the drug's market growth[1].

Marketing and Awareness Campaigns

Pharmaceutical companies are investing heavily in marketing and awareness campaigns to promote Romidepsin, which is also contributing to its growing market presence[1].

Regional Market Analysis

The global Romidepsin market is segmented into several key regions, each with its own dynamics:

Europe

Europe is a mature market with well-established infrastructure and consumer preferences. Countries such as the United Kingdom, Germany, France, and Italy are significant contributors to the regional market[1].

Asia-Pacific

The Asia-Pacific region is experiencing rapid growth, driven by countries like China, Japan, India, and South Korea. Factors such as a large population, rising disposable income, and increasing urbanization are driving the demand for Romidepsin in this region[1].

Latin America

Latin America presents both opportunities and challenges, with countries like Brazil, Mexico, and Argentina being key players. Economic fluctuations and political instability in some countries can impact market dynamics and consumer behavior[1].

Middle East and Africa

The Middle East and Africa represent emerging markets with promising growth potential. Countries such as the UAE, Saudi Arabia, South Africa, and Nigeria are driving demand due to economic diversification efforts, urbanization, and a young population[1].

Financial Performance and Returns

The financial performance of Romidepsin is notable, especially when compared to other cancer drugs:

Sales Income

Romidepsin has generated significant sales income, although it is among the drugs with lower cumulative sales compared to some other cancer treatments. For instance, by the end of 2017, Romidepsin's sales income was lower than that of drugs like rituximab, trastuzumab, and bevacizumab[3].

R&D Costs and Returns

The median income return for every dollar spent on research and development (R&D) for cancer drugs, including Romidepsin, was found to be $14.50 by the end of 2017. This indicates a substantial financial return on investment in R&D for the drug[3].

Mergers and Acquisitions

The Romidepsin market is witnessing a wave of mergers and acquisitions as companies seek to consolidate their market positions, expand their product portfolios, and leverage synergies to drive growth and competitiveness. These strategic consolidations provide access to new technologies, intellectual property, and talent, enabling companies to innovate faster and stay ahead of market trends[1].

Challenges and Opportunities

While the Romidepsin market is growing, it also faces several challenges and opportunities:

Cost and Access

The provision of cancer medicines, including Romidepsin, is costly and managing stock bears substantial financial risk. Ensuring efficient funding and access to these medicines is a significant challenge[2].

Sustainable Solutions

Growing environmental concerns and stringent regulations are fostering a shift towards sustainable alternatives, which could impact the demand for eco-friendly Romidepsin products and services[1].

Technological Innovations

Technological innovations, such as tele-oncology and process enhancements, are expected to improve the efficiency and accessibility of cancer medicines, including Romidepsin[2].

Key Players

The Romidepsin market is dominated by several key players, including:

Merck

Merck is one of the prominent players in the Romidepsin market, known for its significant investment in R&D and marketing efforts[1].

BPS Bioscience, Inc.

BPS Bioscience, Inc. is another key player, contributing to the market through its research and development activities[1].

Selleck Chemicals

Selleck Chemicals is a notable player, providing high-quality Romidepsin products and services[1].

AdooQ BioScience

AdooQ BioScience is also a significant player, known for its innovative approaches in the Romidepsin market[1].

Conclusion

The Romidepsin market is poised for significant growth driven by its efficacy in treating T-cell lymphomas, ongoing research and development, regulatory approval, and strategic marketing efforts. While it faces challenges related to cost and access, the market is expected to benefit from technological innovations and a shift towards sustainable solutions.

Key Takeaways

• Market Growth: The Romidepsin market is expected to grow from USD 8.65 billion in 2024 to USD 17.73 billion by 2031.
• Key Drivers: Increasing adoption in T-cell lymphomas, ongoing R&D, regulatory approval, and marketing efforts.
• Regional Dynamics: Europe, Asia-Pacific, Latin America, and the Middle East and Africa are key regions driving market growth.
• Financial Performance: Romidepsin generates significant sales income, with a substantial return on R&D investment.
• Challenges and Opportunities: Cost and access issues, shift towards sustainable solutions, and technological innovations.

FAQs

1. What is the current market size of Romidepsin and its projected growth?

   • The Romidepsin market is valued at USD 8.65 billion in 2024 and is projected to reach USD 17.73 billion by 2031, with a CAGR of 10.79%[1].

2. Who are the key players in the Romidepsin market?

   • Key players include Merck, BPS Bioscience, Inc., Selleck Chemicals, and AdooQ BioScience[1].

3. What are the main drivers of the Romidepsin market growth?

   • The growth is driven by increasing adoption in T-cell lymphomas, ongoing R&D, regulatory approval, and marketing efforts[1].

4. How does the regional market dynamics impact the Romidepsin market?

   • Europe, Asia-Pacific, Latin America, and the Middle East and Africa are significant regions, each with unique market dynamics and growth drivers[1].

5. What are the challenges facing the Romidepsin market?

   • Challenges include cost and access issues, the need for sustainable solutions, and the impact of technological innovations[1][2].

Sources

1. OpenPR: Romidepsin Market Size, Share and Forecast By Key Players-Merck Group, BPS Bioscience, Inc., Selleck Chemicals, AdooQ BioScience.
2. Consultation Hub: EFC Review Interim Report 2022.
3. JAMA Network: Sales Income and R&D Costs for FDA-Approved Cancer Drugs Sold in the United States.
4. Market Research Intellect: Global Romidepsin Market Size, Scope And Forecast Report.