ISTODAX Drug Patent Profile

When do Istodax patents expire, and when can generic versions of Istodax launch?

Istodax is a drug marketed by Bristol-myers and is included in one NDA.

The generic ingredient in ISTODAX is romidepsin. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the romidepsin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Istodax

A generic version of ISTODAX was approved as romidepsin by FRESENIUS KABI USA on October 12^th, 2021.

Summary for ISTODAX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	46
Patent Applications:	1,426
Drug Prices:	Drug price information for ISTODAX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ISTODAX
What excipients (inactive ingredients) are in ISTODAX?	ISTODAX excipients list
DailyMed Link:	ISTODAX at DailyMed

See drug prices for ISTODAX

Recent Clinical Trials for ISTODAX

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

Sponsor	Phase
GWT-TUD GmbH	Phase 1/Phase 2
AstraZeneca	Phase 1/Phase 2
Changchun Deng	Phase 1

See all ISTODAX clinical trials

Paragraph IV (Patent) Challenges for ISTODAX

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 ISTODAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol-myers	ISTODAX	romidepsin	POWDER;INTRAVENOUS	022393-001	Nov 5, 2009	AP	RX	Yes	Yes

Expired US Patents for ISTODAX

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 ISTODAX

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

International Patents for ISTODAX

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

Country	Patent Number	Title	Estimated Expiration
Finland	893359
Hungary	211514
European Patent Office	1313872
World Intellectual Property Organization (WIPO)	0220817
Austria	94561

Market Dynamics and Financial Trajectory for ISTODAX (Romidepsin)

Last updated: July 27, 2025

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Introduction

ISTODAX (romidepsin) stands as a potent histone deacetylase inhibitor (HDACi), approved for treating specific hematologic malignancies, including peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL). Its development and commercialization have significantly influenced the targeted oncology therapy landscape. This report elucidates the evolving market dynamics and financial trajectory shaping ISTODAX's commercial outlook, emphasizing factors that influence its sales, market share, and future growth potential.

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Market Landscape for HDAC Inhibitors and ISTODAX’s Position

The segment of HDAC inhibitors, of which ISTODAX is a notable player, resonates with an increasing global focus on epigenetic therapies targeting various cancers. The initial approval of ISTODAX by the FDA in 2011 for CTCL, and subsequently in 2018 for PTCL, cemented its role within a niche but expanding oncology segment.

The broader oncology drug market is projected to surpass USD 300 billion by 2027, with targeted therapies like HDAC inhibitors accounting for a significant share due to their specificity and favorable safety profiles [1]. However, competition from other HDAC inhibitors, such as panobinostat (approval for multiple myeloma) and newer agents under clinical development, constrains ISTODAX's growth.

Market Penetration

While ISTODAX benefits from orphan drug designation, limiting competition regulatory hurdles, its penetration remains limited due to factors like:

• Pricing and Reimbursement: As a niche oncology agent, cost considerations heavily influence prescribing patterns.
• Limited Indications: Currently confined to CTCL and PTCL, restricting broader adoption.
• Physician Awareness and Experience: Slightly constrained due to its specialist-targeted application.

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Key Market Dynamics

1. Patent and Regulatory Landscape

ISTODAX’s exclusivity extends until late 2024, after which generic formulations could enter, exerting downward pressure on pricing and sales. The expiration of patents typically precipitates revenue declines unless offset by new indications or formulations.

Regulatory pathways for potential new indications or formulations are critical. The drug's current approvals are based on limited clinical trials, restricting its expansion unless new, supportive clinical data are generated.

2. Competitive Environment

Emerging therapies and pipeline HDAC inhibitors threaten ISTODAX’s market share. Notable competitors include:

• Belinostat (Beleodaq): Approved for PTCL, similar in mechanism but with different efficacy profiles.
• Chidamide: Approved in China for T-cell lymphomas, representing regional competition.
• Novel Epigenetic Agents: Drugs targeting different epigenetic mechanisms or combinatorial approaches are under development.

In addition, combination therapies, especially with immunotherapies like PD-1 inhibitors, are under clinical evaluation, which might influence ISTODAX's future positioning.

3. Clinical Development and Label Expansion

Efforts to expand ISTODAX's indications via clinical trials could stimulate sales. Exploratory studies in solid tumors, combination regimens, and other hematologic malignancies hold potential but are constrained by the drug's established orphan status and the need for sizeable trials.

4. Manufacturing and Supply Chain Considerations

Robust manufacturing processes are critical to meet global demand, especially as demand grows in emerging markets. However, the finite patent life and potential generics challenge the current revenue model, compelling strategic investment in pipeline expansion.

5. Market Access and Pricing Strategies

High treatment costs necessitate favorable reimbursement policies. Negotiations with healthcare payers, especially across different geographies, significantly influence revenue streams. Cost-effectiveness assessments are increasingly pivotal.

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Financial Trajectory and Revenue Drivers

Historical Performance

Since its launch, ISTODAX has demonstrated steady but moderate sales growth, attributable to its niche indication base and regional approval status. In 2021, annual sales approximated USD 50 million globally, reflecting limited but stable demand [2].

Projected Growth Factors

• Patent Exclusivity Window: With patent expiry anticipated around 2024, revenues are expected to decline unless offset by new indications.
• Market Expansion: Regulatory approvals in additional countries, especially in Asia-Pacific, could diversify revenue streams.
• Label Expansion: Positive clinical trial results could facilitate expanded indications, catalyzing sales.
• Strategic Partnerships: Licensing agreements with regional players can enhance market penetration.

Forecast Models

Undoubtedly, sales projections hinge on patent status, competitive dynamics, and clinical trial outcomes. Conservative estimates suggest a potential peak revenue of USD 75-100 million over the next 3-5 years if new indications or formulations are approved. Conversely, after patent expiry, generic entry could reduce sales by upwards of 50%, underscoring the importance of pipeline development.

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Future Outlook

The trajectory of ISTODAX's market performance aligns with broader trends within oncology focused on personalized medicine and epigenetic targeting. Its future depends heavily on lifecycle management strategies:

• Innovative Formulations: Development of oral, sustained-release, or combination formulations.
• Novel Indications: Demonstrating efficacy in other malignancies through rigorous clinical trials.
• Combination Approaches: Co-administering with immune checkpoint inhibitors or chemotherapies to enhance efficacy.

The evolving regulatory landscape, patent protections, and capacity to innovate will significantly shape its financial destiny.

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Key Takeaways

• Market Position: ISTODAX occupies a niche within the epigenetic therapy space, with growth limited by patent expiry, competitive pressures, and indication scope.
• Revenue Outlook: Expected to plateau post-2024 unless strategic initiatives—including new indications, formulations, or market expansion—materialize.
• Competitive Edge: Maintaining clinical relevance requires ongoing investment in clinical research to demonstrate broader efficacy.
• Lifecycle Management: Strategic partnerships, pipeline development, and regulatory filings are vital for sustaining financial performance.
• Market Dynamics: The segment's growth hinges on advancements in personalized oncology, epigenetic therapy innovation, and healthcare policy reforms.

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FAQs

1. When does the patent protection for ISTODAX expire, and what are the implications?
Patent protection for ISTODAX is expected to lapse around late 2024, opening opportunities for generic competition, which could significantly reduce revenues unless the company secures new indications or formulations.

2. What are the main indications for ISTODAX currently?
ISTODAX is approved for cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL), representing its primary marketed indications.

3. How does the competitive landscape influence ISTODAX’s market share?
Emerging HDAC inhibitors and epigenetic therapies, coupled with clinical trials exploring combination strategies, pose significant competitive threats, potentially limiting market share expansion.

4. What opportunities exist for the growth of ISTODAX?
Clinical trial success in new indications, geographical expansion, formulation innovations, and strategic collaborations could drive future growth.

5. How might healthcare policy and reimbursement impact ISTODAX’s financial trajectory?
Favorable reimbursement decisions and cost-effectiveness evaluations will facilitate broader access, impacting sales positively. Conversely, reimbursement challenges could constrain growth.

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References

[1] Market Research Future, "Global Oncology Drugs Market," 2022.

[2] Company financial filings, 2021 Annual Report.