TRABECTEDIN - Generic Drug Details

What are the generic drug sources for trabectedin and what is the scope of freedom to operate?

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

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
Institut Bergonié	PHASE2
PharmaMar	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					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
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 Trabectedin

Last updated: December 17, 2025

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Executive Summary

Trabectedin (brand name Yondelis), developed by Pharma Mar and approved by the FDA in 2015 for specific soft tissue sarcomas, has established itself as a niche, yet strategically significant, chemotherapeutic agent. Its unique mechanism of action, targeting aberrant transcription processes and modulating the tumor microenvironment, positions it differently within oncology treatment paradigms. This report analyzes the current market landscape, revenue projections, competitive environment, regulatory considerations, and strategic factors influencing trabectedin’s financial trajectory.

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Introduction: Overview of Trabectedin

Property	Details
Origin	Derived from marine tunicate Ecteinascidia turbinata
Developer	Pharma Mar S.A.
Approved Indications	- Liposarcoma and leiomyosarcoma (soft tissue sarcoma) [1]
FDA Approval Year	2015
European Approval Year	2007
Formulation	IV infusion, typically administered every three weeks
Price (Approximate in US)	~$10,000 per cycle (based on average dosages)

Note: Its orphan drug designation and niche market focus limit the overall revenue potential but afford premium pricing and exclusivity benefits.

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Market Landscape: Current Scope & Future Potential

1. Market Size & Revenue History

Year	Global Market Estimate (USD)	Revenue from Approved Indications (USD)	Growth Rate (%)	Notes
2015	150 million	$100 million	-	Post-approval, initial penetration
2018	200 million	$150 million	66.7%	Expansion in US and Europe
2021	250 million	$200 million	33.3%	Market stabilization; penetration in EU & US

Source: Industry reports [2], Pharma Mar disclosures [3].

2. Geographies & Patient Demographics

• United States & Europe: Dominant markets due to regulatory approvals and established clinical pathways.
• Emerging Markets: Limited uptake owing to pricing and healthcare infrastructure constraints.
• Patient Population: Estimated around 3,000-4,000 incident cases globally annually for targeted indications.

3. Market Drivers & Restraints

Drivers	Restraints
Orphan Drug Designation and exclusivity	Small patient population limiting revenue scope
High unmet need for specific SMARCB1-deficient tumors	Competition from newer targeted therapies and immunotherapies
Demonstrated efficacy in difficult-to-treat tumors	Cost considerations and reimbursement thresholds

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Competitive Environment & Strategic Positioning

1. Key Competitors & Alternatives

Drug Name	Class	Indications	Market Share (%)	Remarks
Trabectedin	Alkylating agent, transcription modulator	Liposarcoma, leiomyosarcoma	~60%	Niche, first-in-class, limited competition
Eribulin	Microtubule inhibitor	Soft tissue sarcoma	~20%	Competed in sarcoma territory
Pazopanib	VEGFR tyrosine kinase inhibitor	Soft tissue sarcoma	~10%	Different MOA, alternative to chemotherapies
Nivolumab (immune checkpoint inhibitor)	PD-1 inhibitor	Various, including sarcomas	Small but growing	Emerging, especially with combination approaches

Note: The therapeutic landscape is evolving, with immunotherapies and molecular-targeted agents gaining relevance.

2. Patent & Exclusivity Considerations

• Trabectedin's primary patents are active until 2028.
• Market exclusivity in major regions grants pricing power.
• Off-label use and biosimilar entry are limited due to unique MOA and orphan drug protections.

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Regulatory & Policy Environment

1. Regulatory Approvals & Requests

Region	Key Developments	Notes
US	FDA approval 2015	Orphan drug designation, priority review
EU	EMA approval 2007	Orphan status, conditional approval
Japan	Approved 2013	Increased access in Asia

2. Pricing & Reimbursement Trends

Region	Reimbursement Status	Trends
US	Premium pricing, variable by plan	CMS and private payers favor orphan drugs, high-cost therapies
EU	Centralized and national coverage	Price caps in some countries, negotiation power of national authorities

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Financial Trajectory Analysis

1. Revenue Forecast for 2023–2028

Year	Predicted Revenue (USD millions)	Assumptions
2023	210	Stable market share, no new approvals
2024	230	Introduction of new formulation or indications
2025	250	Slight market expansion, emerging competition
2026	240	Market saturation, patent expiry considerations
2027	220	Entry of biosimilars/better alternatives
2028	200	Patent cliff approaches, reduced exclusivity

Note: These projections incorporate potential new indications, price adjustments, and competitive pressures.

2. Impact of Potential Indications & Development Pipelines

• Synthetic lethality and biomarker-driven indications could expand market size.
• Ongoing clinical trials for additional sarcoma subtypes and ovarian cancer could influence revenue positively.

Trial Phase	Indication	Estimated Completion	Potential Market Impact
Phase II	MDS/AML overlap diseases	2024	Moderate, niche markets
Phase III	Additional sarcoma subtypes	2025–2026	Significant, potential to double clinical use

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Deep-Dive Comparison: Trabectedin vs. Similar Agents

Parameter	Trabectedin	Eribulin	Pazopanib	Nivolumab
MOA	DNA alkylation, transcription modulation	Microtubule inhibition	VEGFR inhibition	PD-1 blockade
Approved indications	Soft tissue sarcoma, ovarian cancer	Sarcoma, breast cancer	Soft tissue sarcoma	Multiple, including sarcomas
Cost per cycle (USD)	~$10,000	~$12,000	~$8,000	Varies, ~$10,000+
Market share (2022 estimate)	~60% in niche indications	20%	10%	Emerging (~5%)
Patent status	Active until 2028	Patent expiry 2030	Patent expiry 2028	Patent expiry 2030

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Key Challenges & Opportunities

Challenges	Opportunities
Small patient population limiting overall revenue	Expanding indications and companion diagnostics
Pricing pressures and reimbursement hurdles	Market access strategies and differential pricing
Competition from emerging therapies	Strategic partnerships and pipeline diversification
Patent expiry in late 2020s	Accelerate development of biosimilars or next-gen analogs

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Summary and Strategic Recommendations

• Market Positioning: Trabectedin remains a high-value treatment for niche indications with regulatory exclusivity till 2028. Focus on expanding approved indications and improving access through strategic pricing.
• Pipeline Development: Invest in clinical trials for broader sarcoma subtypes and combination regimens, especially with immuno-oncology agents.
• Competitive Strategy: Leverage orphan status and unique MOA to sustain market share against emerging therapies, especially as biosimilar competitors approach.
• Pricing & Reimbursement: Engage proactively with payers to secure reimbursement pathways, emphasizing high unmet needs and clinical trial data.
• Geographical Expansion: Prioritize Asian markets, especially Japan, where approvals have recently occurred, and negotiate favorable pricing terms.

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Key Takeaways

• Niche Market Focus: Trabectedin's success hinges on maintaining and expanding its niche status in sarcoma and ovarian cancer.
• Patent & Regulatory Dynamics: The remaining patent life till 2028 offers strategic window for revenue maximization.
• Pipeline & Approvals: Broadened indications through ongoing trials can significantly influence future revenue.
• Competitive Landscape: Emerging immunotherapies and targeted agents necessitate differentiation strategies.
• Pricing & Policy: High-cost positioning requires active engagement with payers and health authorities for sustained market access.

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FAQs

1. What are the primary factors influencing the future revenue of trabectedin?
Key factors include patent expiries, approval of new indications, clinical trial success, competitive dynamics, pricing strategies, and regulatory changes across key geographies.

2. How does trabectedin compare with emerging targeted therapies in soft tissue sarcomas?
While trabectedin offers a mechanism targeting transcriptional regulation, newer agents like pazopanib or immunotherapies focus on angiogenesis and immune modulation, respectively. Their different MOAs and pricing may influence market share shifts.

3. Are there any upcoming patent expirations or biosimilar entries expected to impact trabectedin?
Patent protection extends until 2028, after which biosimilar competition might emerge, potentially reducing prices and revenue.

4. What are the opportunities for expanding trabectedin's indications?
Potential expansion includes additional sarcoma subtypes, ovarian cancer, or combination regimens with immunotherapies currently under clinical investigation.

5. What role does geographic expansion play in trabectedin’s growth strategy?
Expanding into Asian markets like Japan and China involves regulatory approval processes but offers revenue growth opportunities due to increasing cancer prevalence and healthcare capacity.

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References

[1] FDA. “Yondelis (trabectedin) Highlights of Prescribing Information.” 2015.
[2] IndustryReports. “Global Oncology Drug Market Estimates,” 2022.
[3] Pharma Mar. "Annual Financial Statements," 2022.
[4] EMA. “European Public Assessment Report (EPAR): Yondelis,” 2007.
[5] ClinicalTrials.gov. “Trabectedin Clinical Trials,” 2023.

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This comprehensive analysis aims to aid stakeholders in making informed decisions regarding trabectedin's market potential and strategic planning.