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. Two suppliers are 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.

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

Recent Clinical Trials for YONDELIS

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

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

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
Argentina	051653	FORMULACIONES
Argentina	110986	COMPOSICIONES DE ECTEINASCIDINA, FORMULACIONES LIOFILIZADAS, MÉTODO DE PREPARACIÓN Y USO
Austria	E368461
Australia	2005227421	Formulations
Brazil	PI0517238	formulações que compreendem ecteinascidina e um dissacarìdeo

Market Dynamics and Financial Trajectory for YONDELIS

Last updated: March 10, 2026

YONDELIS (trabectedin), developed by PharmaMar, has carved a niche in the oncology sector, primarily targeting soft tissue sarcoma (STS) and ovarian cancer. Its market presence depends on regulatory status, competitive landscape, and evolving clinical data.

Regulatory Status

YONDELIS gained European approval in 2007 for relapsed STS, notably after soft tissue sarcoma failed standard chemotherapy. It received accelerated approval by the U.S. FDA in 2015 for use in combination with doxorubicin for advanced soft tissue sarcoma. However, as of 2023, YONDELIS remains unapproved for ovarian cancer in the U.S. and Europe, where it is mainly prescribed for STS.

Market Size and Segments

The global soft tissue sarcoma market was valued at approximately USD 400 million in 2022, with a projected compound annual growth rate (CAGR) of around 8% through 2027. The ovarian cancer segment for trabectedin is smaller, with fewer approved indications, accounting for roughly USD 150 million in 2022.

YONDELIS’s revenues are concentrated in the U.S. and Europe. In 2022, PharmaMar reported global sales of EUR 110 million (~USD 121 million), with approximately 70% derived from STS indications and the remainder from ovarian and other rare cancers.

Competitive Landscape

The primary competitors are:

• Pazopanib (Votrient), approved for STS.
• Doxorubicin and ifosfamide, standard chemotherapies with generic pricing.
• Trabectedin's main competitors in ovarian cancer are limited, but olaparib, a PARP inhibitor, has gained prominence in maintenance therapy post-chemotherapy.

Market share remains modest due to:

• Limited indications and off-label use restrictions.
• Competition from newer targeted agents and immunotherapies.
• High treatment costs relative to its niche positioning.

Revenue Projections and Growth Factors

PharmaMar expects YONDELIS revenues to stabilize at EUR 70-100 million annually through 2025, reflecting mature market penetration in Europe and the US.

Key factors influencing growth:

• Regulatory Expansion: Potential approvals for additional indications, such as other sarcomas or combination therapies.
• Clinical Development: Ongoing trials might support label expansions or new drug combinations.
• Pricing Strategies: Negotiation outcomes with payers influence revenue potential.
• Market Penetration: Increased adoption due to clinician familiarity and updated treatment guidelines.

Challenges and Risks

• Regulatory Hurdles: Delays or rejections for new indications could restrain growth.
• Competitive Pressure: Emergence of targeted therapies and immunotherapies may limit market share.
• Pricing Constraints: Cost negotiations in key markets could reduce margins.
• Uncertainty of Clinical Outcomes: Results from ongoing trials may not meet expectations, affecting future approvals.

Financial Outlook

Over the next three years, PharmaMar's YONDELIS revenue is expected to grow modestly or remain stable unless new indications are approved or market access improves significantly. Operating margins are constrained by pricing pressures and R&D investments in complementary therapies.

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Key Takeaways

• YONDELIS holds a niche in relapsed soft tissue sarcoma and has limited presence in ovarian cancer.
• Revenue in 2022 was approximately EUR 110 million (~USD 121 million), driven mainly by market penetration in Europe and the U.S.
• Growth prospects depend on regulatory expansions, clinical trial success, and market access negotiations.
• Competitive landscape favors targeted therapies and immunotherapies, constraining YONDELIS’s market share.
• Risks include regulatory delays, market competition, and pricing pressures.

FAQs

What are the primary approved uses of YONDELIS?
YONDELIS is approved in Europe for soft tissue sarcoma and in the U.S. for combination therapy with doxorubicin for advanced soft tissue sarcoma in previously treated patients.

What factors limit YONDELIS growth?
Limited approved indications, competitive therapies, and high treatment costs restrict growth.

Are there ongoing trials to expand YONDELIS indications?
Yes, PharmaMar is conducting clinical trials in different sarcoma subtypes and combination regimens, but outcomes are pending.

How does YONDELIS compare to other sarcoma treatments?
It offers a different mechanism as a DNA-binding agent, but pricing and approval scope limit its market share relative to more established chemotherapies and targeted agents.

What are the biggest risks to YONDELIS’s financial trajectory?
Regulatory challenges, failure to expand indications, competitive innovations, and reimbursement restrictions.

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References

1. PharmaMar. (2022). Annual Report. Retrieved from https://pharmamar.com
2. MarketWatch. (2023). Soft tissue sarcoma market forecast. Retrieved from https://marketwatch.com
3. FDA. (2015). Approval letter for trabectedin. Retrieved from https://fda.gov
4. European Medicines Agency. (2007). Approval for YONDELIS. Retrieved from https://ema.europa.eu
5. GlobalData. (2023). Oncology drugs pipeline and market analysis.