Trabectedin - Generic Drug Details

What are the generic drug sources for trabectedin and what is the scope of patent protection?

Trabectedin is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are four drug master file entries for trabectedin. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for trabectedin

International Patents:	44
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	99
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for trabectedin
What excipients (inactive ingredients) are in trabectedin?	trabectedin excipients list
DailyMed Link:	trabectedin at DailyMed

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

Constraining patent/regulatory exclusivity:

8,895,557*PED

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 trabectedin

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

Sponsor	Phase
M.D. Anderson Cancer Center	PHASE2
University Hospital, Marseille	PHASE2
National Research Agency, France	PHASE2

See all trabectedin clinical trials

Generic filers with tentative approvals for TRABECTEDIN

Applicant	Application No.	Strength	Dosage Form
		1MG	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for trabectedin

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Anatomical Therapeutic Chemical (ATC) Classes for trabectedin

L01CX	Other plant alkaloids and natural products
L01C	PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for TRABECTEDIN

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 trabectedin

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	8,895,557*PED				Y

EU/EMA Drug Approvals for trabectedin

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 trabectedin

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0517238	formulações que compreendem ecteinascidina e um dissacarìdeo
Croatia	P20070374
Taiwan	I296523
New Zealand	554761	Formulations comprising ecteinascidin and a disaccharide

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Trabectedin

Last updated: July 29, 2025

Introduction

Trabectedin, marketed as Yondelis, stands out as a pioneering chemotherapeutic agent developed initially from the sea squirt Ecteinascidia turbinata. Approved for specific soft tissue sarcomas and ovarian cancer, its unique mechanism of action and limited but targeted indications have shaped a distinctive market profile. Understanding trabectedin’s market dynamics and financial trajectory offers insights into its positioning amid competitive oncology treatments, licensing agreements, and ongoing clinical development.

Understanding Trabectedin: Mechanism and Indications

Trabectedin functions as a DNA minor groove binder, disrupting transcription-coupled nucleotide excision repair pathways, resulting in apoptosis of malignant cells. Its approved indications for soft tissue sarcoma (STS) and recurrent ovarian cancer have restricted its use to niche patient populations, aligning with precision oncology's trend.

The European Medicines Agency (EMA) approved trabectedin in 2007 for advanced STS following prior chemotherapy, with subsequent approval in the U.S. by the FDA in 2015. The drug's targeted mechanism and tolerability profile appeal to oncologists, yet its market penetration remains constrained by limited indications, high cost, and competition from emerging treatments.

Market Size and Demand Drivers

Current Market Landscape

The global oncology drug market is projected to reach approximately $200 billion by 2028, with niche agents like trabectedin constituting a small but significant segment. According to IQVIA data, the annual sales of trabectedin hovered around $150-200 million (USD) as of 2022, primarily driven by European markets and select North American territories.

Growth Drivers

• Patient Population: The incidence of soft tissue sarcomas remains low, estimated at approximately 5 cases per 100,000 annually globally. Recurrent ovarian cancer affects a larger demographic but remains a niche market, capping overall demand.

• Regulatory Approvals: Expanding approvals in additional indications or formulations (e.g., combination therapies) could enlarge the addressable patient base.

• Clinical Adoption & Efficacy Perception: Growing evidence supporting trabectedin’s efficacy in specific sarcoma subtypes bolsters its adoption. However, competition with therapies like pazopanib, liposomal doxorubicin, and immunotherapies influences market share.

Competitive Dynamics

Key Competitors

• Pazopanib: An oral tyrosine kinase inhibitor approved for advanced soft tissue sarcomas.
• Doxorubicin & Ifosfamide: Traditional chemotherapy agents with broader indications.
• Emerging Immunotherapies: PD-1/PD-L1 inhibitors and targeted agents poised to alter treatment paradigms.

Market Positioning

Trabectedin’s niche relies on its unique mechanism, especially in patients resistant to first-line treatments. Its high cost (~$8,000 per 3 mg vial in the U.S.) positions it as a premium agent, limiting utilization but favoring specialized centers with supportive healthcare policies.

Market Penetration Challenges

• High treatment costs versus modest survival benefits.
• Limited indications restrict volume.
• Competition from newer, targeted, or immunotherapeutic agents with potentially superior efficacy profiles in overlapping patient groups.

Regulatory and Licensing Dynamics

Manufacturing & Licensing Agreements

• Pharmaceutical Partnerships: The originator, PharmaMar, maintains licensing agreements with global biopharmaceutics companies. For instance, Jazz Pharmaceuticals has a distribution agreement for North America.
• Expanding Regulatory Approvals: Recent submissions for additional indications or new formulations (e.g., liposomal variants) could extend market reach.

Pricing & Reimbursement Landscape

Pricing strategies and reimbursement policies significantly influence market penetration. Europe's reimbursement frameworks have generally favored trabectedin due to its targeted efficacy, yet cost constraints remain notable in some markets.

Financial Trajectory and Future Outlook

Revenue Trends

While initial sales growth was modest, a stable revenue stream has been established owing to consistent clinical adoption in approved indications. However, the market's saturation limits explosive growth.

Research & Development Investments

PharmaMar continues to invest in clinical trials investigating trabectedin in combination therapy (e.g., with pegylated liposomal doxorubicin), aiming to expand its use beyond current indications. Successful outcomes could unlock new revenue streams and improve its financial trajectory.

Pipeline Prospects

• New Indications: Sporadic pipeline updates include trials in myxoid liposarcoma and certain leukemias.
• Formulation Innovations: Liposomal formulations may improve safety and efficacy, broadening appeal.

Growth Scenarios

• Optimistic: Demonstration of superior efficacy in new indications or combination regimens could spike revenues, supported by expanding approvals.
• Conservative: Market saturation, high costs, and stiff competition from immunologically targeted therapies could suppress significant growth, rendering stable but modest revenues.

Market Challenges and Opportunities

Challenges

• Limited indications constrain volume.
• High cost limits accessibility and reimbursement.
• Competition with emerging therapies reduces market share.

Opportunities

• Expanding clinical trials may open new therapeutic avenues.
• Strategic licensing and partnership deals could enhance global reach.
• Innovations in drug delivery and combination options could improve outcomes and patient adherence.

Key Takeaways

• Trabectedin maintains a niche but vital role within targeted sarcoma and ovarian cancer therapies.
• Current annual revenue aligns with a niche drug in specialized markets but faces stagnation due to limited indications.
• Market growth potential hinges on expanding approvals, optimizing pricing models, and demonstrating superior clinical benefits.
• Competitive pressures from immunotherapies and targeted agents necessitate strategic positioning specializing in resistant or rare cancer subtypes.
• Ongoing R&D investments and pipeline developments could significantly influence future financial trajectories, either through expanded indications or formulation improvements.

Frequently Asked Questions (FAQs)

1. What are the primary indications for trabectedin?
   Trabectedin is approved for advanced soft tissue sarcoma following prior chemotherapy and recurrent ovarian cancer in various regulatory regions.

2. How does the cost of trabectedin impact its market share?
   Its high price (~$8,000 per vial in the U.S.) restricts widespread use, limiting accessibility mainly to specialized oncology centers.

3. What are the main competitors of trabectedin?
   Key competitors include pazopanib, liposomal doxorubicin, and emerging immunotherapies with broader or newer mechanisms.

4. Can trabectedin's market expand into new indications?
   Yes, ongoing clinical trials investigating its efficacy in other cancers could unlock additional markets if successful.

5. What strategic moves could enhance trabectedin's financial prospects?
   Expanding indications, developing combination therapies, optimizing pricing, and forming strategic partnerships will be critical.

References

[1] IQVIA. “2022 Oncology Market Reports.”
[2] European Medicines Agency. “Yondelis (trabectedin) Summary of Product Characteristics.”
[3] U.S. Food and Drug Administration. “FDA Approval Documents for Trabectedin.”
[4] PharmaMar. “Corporate Reports and Pipeline Updates.”
[5] MarketWatch. “Oncology Therapy Market Outlook 2023-2028.”