YONDELIS Drug Patent Profile

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

Yondelis is a drug marketed by Janssen Prods and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty-four patent family members in thirty-six countries.

The generic ingredient in YONDELIS is trabectedin. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trabectedin profile page.

DrugPatentWatch^® Generic Entry Outlook for Yondelis

Yondelis was eligible for patent challenges on October 23, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 7, 2028. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (trabectedin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for YONDELIS

International Patents:	44
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	51
Drug Prices:	Drug price information for YONDELIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for YONDELIS
What excipients (inactive ingredients) are in YONDELIS?	YONDELIS excipients list
DailyMed Link:	YONDELIS at DailyMed

See drug prices for YONDELIS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for YONDELIS

NDA:

207953

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for YONDELIS

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

Sponsor	Phase
Anturec Pharmaceuticals GmbH	Phase 3
Westfälische Wilhelms-Universität Münster	Phase 3
Rain Therapeutics Inc.	Phase 3

See all YONDELIS clinical trials

Pharmacology for YONDELIS

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Paragraph IV (Patent) Challenges for YONDELIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
YONDELIS	Powder for Injection	trabectedin	1 mg/vial	207953	2	2020-04-23

US Patents and Regulatory Information for YONDELIS

YONDELIS is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Prods	YONDELIS	trabectedin	POWDER;INTRAVENOUS	207953-001	Oct 23, 2015		RX	Yes	Yes					Y

EU/EMA Drug Approvals for YONDELIS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pharma Mar S.A.	Yondelis	trabectedin	EMEA/H/C/000773Yondelis is indicated for the treatment of patients with advanced soft-tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.	Authorised	no	no	no	2007-09-17
Pharma Mar S.A.	Yondelis	trabectedin	EMEA/H/C/000464Yondelis is indicated for the treatment of patients with advanced soft tissue sarcoma, having failed antracyclines and ifosfamide, or having failed ifosfamide and unsuitable to receive antracyclines/ifosfamide.	Refused	no	no	no		2004-09-07

International Patents for YONDELIS

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2007119724	КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ЭКТИНЭСАЙДИН И ДИСАХАРИД
Peru	20060925	COMPOSICION FARMACEUTICA QUE COMPRENDE ECTEINASCIDINA Y UN DISACARIDO
Guatemala	200500314	FORMULACIONES

Market Dynamics and Financial Trajectory for YONDELIS

Last updated: July 27, 2025

Introduction

YONDELIS (trabectedin) is a chemotherapeutic agent developed by PharmaMar S.A., primarily approved for the treatment of advanced soft tissue sarcoma (STS) and relapsed ovarian cancer. Since its initial approval, YONDELIS's market performance hinges on evolving clinical guidelines, regulatory decisions, competitive landscape, and expanding indications. This analysis explores its current market dynamics and financial trajectory, providing insights relevant for stakeholders including pharmaceutical companies, investors, and healthcare providers.

Product Overview and Current Indications

YONDELIS is a marine-derived alkaloid that exerts cytotoxic effects by binding to the minor groove of DNA, disrupting transcription processes in cancer cells. Its primary approved indications include:

• Unresectable or metastatic liposarcoma or leiomyosarcoma after chemotherapy failure (European Union, 2015; U.S. FDA approval in 2016)
• Recurrent ovarian cancer following platinum-based therapy (certain jurisdictions, under expanded access programs)

Regulatory agencies like the FDA and EMA have recognized YONDELIS for its targeted niche, though it remains restricted to specific cancer types, limiting broader sales.

Market Dynamics

Competitive Landscape

YONDELIS operates within a tightly contested oncology market. The landscape includes:

• Traditional chemotherapies: Doxorubicin, ifosfamide, and paclitaxel remain frontline agents in sarcomas and ovarian cancer.
• Targeted therapies and immunotherapies: Recent advances such as pazopanib, eribulin, and immune checkpoint inhibitors are gaining ground.
• Emerging agents: Novel drugs that offer superior efficacy or reduced toxicity threaten YONDELIS's market share.

Given the niche indications, YONDELIS faces limited direct competition in soft tissue sarcomas, but the overall market is competitive with multiple treatment options.

Regulatory and Clinical Developments

Recent clinical trials are investigating YONDELIS in combination regimens, potentially expanding its therapeutic window. US Orphan Drug status and EMA conditional approvals facilitate market entry but subject the product to post-approval studies that could affect reimbursement and usage patterns.

Market Penetration and Adoption

Uptake varies geographically. In Europe, especially within the EU's centralized procedures, YONDELIS is well-established for sarcoma. In the US, its utilization is confined primarily to advanced liposarcoma and leiomyosarcoma cases, with adoption influenced by physician familiarity, treatment guidelines, and reimbursement frameworks.

Pricing and Reimbursement

Pricing strategies are aligned with other oncology agents, with significant influence from payers' reimbursement policies. High drug costs and limited reimbursement in certain regions can act as barriers to widespread adoption.

Financial Trajectory and Revenue Projections

Historical Performance

PharmaMar reported revenue of approximately €90 million for YONDELIS in 2021, reflecting steady growth driven by expanded indications and geographic expansion (PharmaMar Annual Report 2021). The key revenue streams originate from Europe, North America, and select Asian markets.

Future Revenue Drivers

• Expansion of Indications: Investigations into YONDELIS in combination therapies and additional cancer types may unlock new revenue potential.
• Geographic Expansion: Entry into emerging markets like Asia-Pacific, where oncology drug markets are expanding rapidly, could significantly boost sales.
• Regulatory Approvals: Positive outcomes from ongoing clinical trials could lead to accelerated approvals and broader use.

Potential Market Size

Based on epidemiological data, the global market for soft tissue sarcoma treatments exceeds $300 million annually, with unmet needs in resistant cases. With YONDELIS occupying a niche segment, its potential to capture larger market shares depends on clinical success and competitive positioning.

Challenges Impacting Financial Growth

• Competition from newer therapies
• Biosimilar threats, although currently limited
• Pricing pressures amid healthcare cost containment initiatives
• Regulatory hurdles for label expansions

Strategic Outlook

PharmaMar aims to diversify YONDELIS’s applications and strengthen its position via:

• Research collaborations: Partnering with academic institutions and biotech firms for innovative combination studies.
• Post-market studies: Demonstrating efficacy in broader populations to support label extensions.
• Market access strategies: Negotiating favorable reimbursement policies, especially in cost-sensitive markets.

The company's strategic focus on its oncology pipeline and regional expansion efforts indicates a cautiously optimistic financial outlook.

Conclusion

YONDELIS’s market dynamics are shaped by its niche indications, evolving competitive environment, and regulatory landscape. While current revenues benefit from established use in specific sarcoma subtypes, the future hinges on clinical and regulatory progress, geographic expansion, and integration into combination regimens. For stakeholders, monitoring these factors is vital to predicting the drug’s trajectory and maximizing its commercial potential.

---

Key Takeaways

• YONDELIS is a specialized chemotherapeutic agent with steady current revenue but limited growth potential without indication expansion.
• Competition from emerging therapies and pricing pressures remain significant challenges.
• Expansion into new indications and markets could substantially enhance revenues.
• Clinical development, regulatory approvals, and strategic collaborations are critical levers for future growth.
• Stakeholders should focus on monitoring ongoing clinical trials and reimbursement policies to gauge YONDELIS’s long-term trajectory.

---

FAQs

1. What are the main factors influencing YONDELIS’s market share?
Clinical efficacy, regulatory approvals for new indications, competitive therapies, reimbursement policies, and physician familiarity directly impact its market penetration.

2. How does YONDELIS compare with other sarcoma treatments?
YONDELIS offers a targeted mechanism of action suited for refractory cases, but newer agents with broader or more effective profiles are competing for similar patient populations.

3. Are there opportunities for YONDELIS in combination therapies?
Yes, ongoing clinical trials are exploring its use with other agents, which could extend its clinical utility and market potential.

4. What regional markets present growth opportunities for YONDELIS?
Emerging markets in Asia-Pacific and Latin America, coupled with expanded access in Europe and North America, offer significant growth potential.

5. What risks could impede YONDELIS’s financial growth?
Regulatory delays, clinical trial failures, increased competition, pricing and reimbursement pressures, and generic/biosimilar threats pose risks to revenue expansion.

---

Sources

1. PharmaMar Annual Report 2021.
2. U.S. Food and Drug Administration (FDA) approvals and labels.
3. European Medicines Agency (EMA) product information.
4. Market research reports on oncology drug markets.
5. Clinical trial databases (ClinicalTrials.gov).