ROMIDEPSIN Drug Patent Profile

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

Romidepsin is a drug marketed by Fresenius Kabi Usa and Teva Pharms Usa Inc and is included in two NDAs.

The generic ingredient in ROMIDEPSIN 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 Romidepsin

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

Summary for ROMIDEPSIN

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	102
Patent Applications:	2,895
Drug Prices:	Drug price information 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
H. Lee Moffitt Cancer Center and Research Institute	PHASE1
AstraZeneca	PHASE1
The First Affiliated Hospital with Nanjing Medical University	NA

See all ROMIDEPSIN clinical trials

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
Fresenius Kabi Usa	ROMIDEPSIN	romidepsin	POWDER;INTRAVENOUS	206254-001	Oct 12, 2021	AP	RX	No	No
Teva Pharms Usa Inc	ROMIDEPSIN	romidepsin	SOLUTION;INTRAVENOUS	208574-001	Mar 13, 2020		DISCN	Yes	No
Teva Pharms Usa Inc	ROMIDEPSIN	romidepsin	SOLUTION;INTRAVENOUS	208574-002	Mar 13, 2020		DISCN	Yes	No

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/002122treatment of peripheral T-cell lymphoma (PTCL),	Refused	no	no	yes		2013-02-12

Market Dynamics and Financial Trajectory for ROMIDEPSIN

Last updated: February 27, 2026

What Is the Current Market Position of Romidepsin?

Romidepsin, marketed as Istodax, is an FDA-approved histone deacetylase (HDAC) inhibitor primarily used for treating cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL) in patients who have received prior therapies. Since its FDA approval in 2011, Romidepsin has maintained a niche position within the oncology therapeutics market.

In 2022, the drug generated approximately $100 million in global revenues, with the majority originating from North America. Its market share remains modest against broader oncology agents but is sustained by its specialized indication and limited competition, with other HDAC inhibitors like belinostat and vorinostat offering alternative treatments.

What Are the Key Market Drivers?

Unmet Medical Need

Romidepsin targets rare lymphomas with limited treatment options, creating consistent demand among a specific patient subset. The incidence of CTCL and PTCL in the United States covers roughly 1,000 to 2,000 new cases annually, indicating a small but steady market.

Regulatory Status and Approvals

The drug holds orphan drug designation for CTCL and PTCL, simplifying development pathways and providing market exclusivity until 2026, potentially delaying generic competition.

Competitive Landscape

Romidepsin faces competition from other HDAC inhibitors like panobinostat, approved for multiple myeloma, and vorinostat, approved for CTCL. However, differences in efficacy profiles, approval statuses, and side effect profiles influence prescribing patterns favorably for Romidepsin in its niche.

Pricing and Reimbursement

Pricing strategies involve a wholesale acquisition cost (WAC) of approximately $5,000 per vial, with typical treatment courses costing around $20,000. Insurance coverage is stable, although reimbursement pressures in some markets are emerging.

How Do Market Dynamics Influence Revenue Potential?

Patent and Patent Expiry

The patent for Romidepsin is set to expire in 2024 in the U.S., risking biosimilar entry. However, orphan drug exclusivity extends until 2026, maintaining market protection until then.

Generics and Biosimilars

Post-patent expiry, biosimilars could reduce revenues significantly. Similar compounds entering the market could lead to a 30-50% price reduction within two years.

Market Expansion Opportunities

Research into Romidepsin's efficacy in other lymphomas or solid tumors is ongoing, with some early-stage trials. Success in expanded indications could extend revenue streams.

Pricing and Access Trends

Price erosion could accelerate if biosimilars are approved, especially in competitive markets like Europe and Asia. Reimbursement reforms may further pressure profit margins.

What Are the Financial Projections?

Revenue Forecasts

Analysts project a decline in U.S. sales from ~$100 million in 2022 to approximately $70 million by 2026, assuming typical biosimilar competition and patent expiration. Global sales are forecasted between $150 million and $200 million annually until 2025, then declining unless new indications are approved.

Investment Implications

R&D investments into combination therapies or new indications could capitalize on existing market share or create new revenue streams. Clinical trials are ongoing for Romidepsin in non-Hodgkin lymphomas and other hematologic malignancies.

Cost Considerations

Manufacturing costs are stable, but marketing and R&D expenses are expected to rise as competitors seek to develop next-generation HDAC inhibitors or combination regimens.

How Do Regulatory and Policy Changes Affect Outlook?

Changes in orphan drug policies and approval pathways could impact market exclusivity periods. International variations in reimbursement and approval processes influence global sales potential. Price control measures in the EU and Asia could constrain revenue growth.

Summary of Financial and Market Risks

• Patent expiration in 2024 risks biosimilar market entry.
• Competition from emerging HDAC inhibitors could undercut market share.
• Expansion trials could fail, limiting revenue growth from new indications.
• Pricing pressures from health systems and insurers could reduce profit margins.
• Regulatory changes could shorten exclusivity or alter reimbursement models.

Key Takeaways

• Romidepsin has a stable but niche market with approximately $100 million in revenue in 2022.
• Patent expiry in 2024 and biosimilar entry pose significant revenue risks.
• Expansion into new indications offers potential upside but remains uncertain.
• Market share is influenced by competitors, pricing strategies, and regulatory policies.
• Long-term profitability depends on pipeline success and ability to maintain exclusivity.

FAQs

1. What is the patent status of Romidepsin?
   Patent protection expires in 2024 in the U.S., with orphan drug exclusivity extending until 2026.

2. Could biosimilars significantly impact Romidepsin revenues?
   Yes, biosimilars could reduce prices by 30-50% once they enter the market post-patent expiry.

3. Are there any ongoing trials for new indications?
   Yes, Romidepsin is being tested in other hematologic malignancies, including non-Hodgkin lymphomas.

4. What is the main competition for Romidepsin?
   Other HDAC inhibitors like vorinostat and belinostat, along with emerging agents, compete in similar indications.

5. How do reimbursement policies influence Romidepsin?
   Insurance coverage provides stable reimbursement in key markets, but policy shifts could impose pricing or usage restrictions.

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References

1. Food and Drug Administration. (2011). FDA approves Istodax for cutaneous T-cell lymphoma.
2. MarketWatch. (2022). Romidepsin market analysis and revenue estimates.
3. EvaluatePharma. (2023). Oncology drug market forecasts.
4. U.S. Patent Office. (2023). Patent expiration dates for Romidepsin.
5. European Medicines Agency. (2023). Regulatory updates on HDAC inhibitors.