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. Three 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:	43
Clinical Trials:	46
Patent Applications:	4,652
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
AstraZeneca	Phase 1/Phase 2
GWT-TUD GmbH	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/002122 treatment 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
Hungary	211514
United Kingdom	8817743
China	1040054

ISTODAX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ISTODAX (Romidepsin)

Introduction

ISTODAX, known scientifically as romidepsin, is a histone deacetylase (HDAC) inhibitor used in the treatment of certain types of cancer. Here, we will delve into the market dynamics and financial trajectory of this drug, highlighting its development, regulatory status, and market performance.

Mechanism of Action and Clinical Use

ISTODAX works by inhibiting the activity of histone deacetylases, enzymes that remove acetyl groups from histones, thereby modulating gene expression. This mechanism leads to the accumulation of acetylated histones, causing cell arrest and apoptosis in some cancer cell lines. It is primarily used as a monotherapy for the treatment of cutaneous T-cell lymphoma (CTCL) and, until recently, peripheral T-cell lymphoma (PTCL)[4][5].

Regulatory History and Approval

ISTODAX received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of CTCL in patients who have received at least one prior systemic therapy. This approval was based on positive results from clinical trials showing a good overall response rate. However, when Bristol Myers Squibb (BMS) expanded the study into a Phase III trial to confirm findings for PTCL, the drug failed to meet its primary efficacy endpoint of progression-free survival, leading to its withdrawal from the PTCL market[4].

Market Dynamics

Competitive Landscape

The HDAC inhibitor market, where ISTODAX is positioned, is highly competitive and dynamic. The market is driven by the constant quest for more effective and safer drugs, with numerous players including large pharmaceutical companies and biotech startups. Licensing agreements, collaborations, and acquisitions are common strategies to gain a competitive edge and expand portfolios[1].

Market Performance

Despite the withdrawal from the PTCL market, ISTODAX remains an important treatment option for CTCL. The drug's performance is influenced by regulatory factors, with the approval process being complex and closely scrutinized by regulatory bodies. The failure in the PTCL trial has impacted its market share and revenue potential, but it continues to generate revenue from its approved indication for CTCL[4].

Financial Trajectory

Revenue Impact

The withdrawal of ISTODAX from the PTCL market has had a significant financial impact on BMS. The drug's revenue was expected to grow with its expanded use in PTCL, but the failure to meet efficacy endpoints has curtailed these expectations. However, the drug still contributes to BMS's revenue stream from its use in CTCL patients[4].

Financial Reporting

In the context of BMS's overall financial performance, the impact of ISTODAX's withdrawal is part of a broader portfolio management strategy. BMS has a diverse pipeline and portfolio, including other successful drugs and therapies that offset the financial impact of ISTODAX's reduced market scope. For instance, BMS's acquisition of MyoKardia and the approval of other therapies like Breyanzi (liso-cel) have contributed significantly to its financial health[3].

Challenges and Opportunities

Regulatory Challenges

The regulatory environment plays a crucial role in the financial trajectory of ISTODAX. The complex and stringent approval process, coupled with the need for rigorous safety and efficacy evaluations, poses challenges for market entry and expansion. Regulatory agencies' updates to guidelines and requirements can impact development timelines and market strategies[1].

Market Fragmentation

The HDAC inhibitor market is fragmented, with multiple players and therapies in various stages of development. This fragmentation can lead to pricing pressures and competition for market share, affecting the financial performance of individual drugs like ISTODAX[1].

Future Outlook

Despite the setbacks, ISTODAX remains a valuable asset for BMS in the treatment of CTCL. The company continues to support patients using ISTODAX and provides access and reimbursement support. The focus on unmet needs in cancer and other diseases ensures that HDAC inhibitors, including ISTODAX, will remain relevant in the therapeutic landscape[4].

Key Takeaways

• Regulatory Approval and Withdrawal: ISTODAX received FDA approval for CTCL but was withdrawn from the PTCL market due to failure in a Phase III trial.
• Market Dynamics: The HDAC inhibitor market is competitive, with a focus on safer and more effective drugs.
• Financial Impact: The withdrawal from PTCL has reduced revenue potential, but ISTODAX still generates revenue from CTCL.
• Regulatory Challenges: Stringent approval processes and regulatory updates impact market entry and expansion.
• Market Fragmentation: Multiple players and therapies lead to pricing pressures and competition.

FAQs

What is ISTODAX used for?

ISTODAX (romidepsin) is used as a monotherapy for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

Why was ISTODAX withdrawn from the PTCL market?

ISTODAX was withdrawn from the peripheral T-cell lymphoma (PTCL) market after a Phase III trial failed to show that it met its primary efficacy endpoint of progression-free survival.

How does ISTODAX work?

ISTODAX works by inhibiting histone deacetylases, leading to the accumulation of acetylated histones, which causes cell arrest and apoptosis in some cancer cell lines.

What are the common adverse reactions associated with ISTODAX?

Common adverse reactions include fatigue, nausea, vomiting, diarrhea, and thrombocytopenia, among others, as observed in clinical trials[5].

What is the current market status of ISTODAX?

ISTODAX remains an approved and important treatment option for CTCL, despite its withdrawal from the PTCL market.

Sources

1. DelveInsight: "Stunning Growth Projection for HDAC Inhibitor Market: DelveInsight's Analysis Reveals Key Drivers and Emerging Treatments" - Globenewswire.
2. Verastem, Inc.: "Verastem Reports Third Quarter 2017 Financial Results" - Businesswire.
3. Bristol Myers Squibb: "2020 Annual Report" - BMS.
4. BioSpace: "BMS Pulls Istodax in Lymphoma After Trial Fails to Show Efficacy" - Biospace.
5. FDA: "ISTODAX (romidepsin) Label" - FDA.