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 two branded drugs marketed by Janssen Prods and Apotex, and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for TRABECTEDIN

International Patents:	45
US Patents:	2
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
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:

12,303,506

Dosage:

SOLUTION;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 Claudius Regaud	PHASE2
University Hospital, Marseille	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
Apotex	EVDI	trabectedin	SOLUTION;INTRAVENOUS	220837-001	May 1, 2026		RX	Yes	Yes	12,303,506		Y
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
European Patent Office	4215184	COMPOSITION DE TRABECTÉDINE (TRABECTEDIN COMPOSITION)
Argentina	051653	FORMULACIONES
Argentina	110986	COMPOSICIONES DE ECTEINASCIDINA, FORMULACIONES LIOFILIZADAS, MÉTODO DE PREPARACIÓN Y USO
Austria	E368461

Trabectedin Market Dynamics and Financial Trajectory: Uptake, Pricing, Competitive Shifts, and Revenue Outlook

Last updated: July 5, 2026

Trabectedin (marketed as Yondelis by Janssen; historical brand: PharmaMar) has remained a niche oncology drug with revenue driven by second-line and later soft-tissue sarcoma (STS) use, cyclic demand tied to guideline inclusion and physician adoption, and incremental geography-by-geography competitive displacement. Financial trajectory has been constrained by (1) narrow indications versus blockbuster oncology benchmarks, (2) limited line-of-therapy penetration, (3) pricing pressure and reimbursement friction in lower-penetration markets, and (4) cycle and combination-efficacy dynamics that have not translated into broad frontline adoption.

How has trabectedin’s market grown and declined since launch?

Bottom line: Trabectedin’s commercial curve has followed a “late adopter” pattern with limited inflection points from label expansions, while overall demand stayed structurally modest due to narrow eligible populations in STS and the absence of broad, tumor-agnostic uptake.

What were the main demand drivers?

1. Indication concentration in STS
   • Yondelis is positioned for advanced STS after specific prior therapies. This inherently caps addressable volume compared with earlier-line or multiple-tumor programs.
2. Oncology guideline inclusion and regimen fit
   • Use is linked to guideline recommendations, clinician comfort, and sequencing against standard-of-care options such as doxorubicin-based regimens earlier and other cytotoxics or targeted approaches later.
3. Combination adoption
   • Market penetration can accelerate when trabectedin fits into established combination pathways, but adoption depends on demonstrable survival or response benefit and manageable safety.

What were the main demand constraints?

• Competing cytotoxics and newer targeted regimens
  • In STS, multiple active options exist across subtypes and prior-therapy settings. Trabectedin’s relative positioning has to compete against alternatives that may be easier to use or better tolerated.
• Reimbursement and procurement friction
  • Specialty oncology procurement often favors pooled purchasing contracts and entrenched regimens; when a brand is non-blockbuster, tender outcomes can materially affect net pricing.
• Clinical practice variability by histology
  • STS is heterogeneous. Even with approvals, real-world volume depends on physician histology selection and how strictly payers and formularies interpret label criteria.

What is trabectedin’s revenue trajectory by region and payer type?

Bottom line: Revenue is best understood as a set of country-level specialty oncology reimbursement outcomes rather than a single global pricing story. Western Europe and select markets typically drive the bulk of sales, with North America demand historically challenged by uptake constraints relative to local standard regimens.

Key regional patterns that typically govern trabectedin outcomes

• EU5 and UK: Higher demand tends to correlate with stronger specialist networks, steadier uptake in second-line STS, and established contracting channels for specialty oncology.
• US: Revenue depends on competitiveness versus US-preferred sequencing and the degree of physician adoption in sarcoma centers. Adoption can be slower without broad second-line consensus.
• Emerging markets: Uptake is usually more sensitive to pricing, logistics of infusion-based therapies, and tender-driven procurement.

Payer dynamics that influence net sales

• Specialty pharmacy vs hospital outpatient
  • Trabectedin is administered in controlled settings, so hospital procurement and reimbursement classification heavily influence net price realization.
• Formulary barriers
  • Narrow indications mean formulary status is often “limited” or requires prior authorization, which can reduce penetration.

What financial trajectory has Janssen/PharmaMar shown for trabectedin?

Bottom line: Financial impact has been material for the company at the portfolio level mainly because sarcoma is high-importance but not high-volume. As broader oncology franchise performance tends to dominate investor narratives, trabectedin’s contribution often appears as a stabilizer rather than a growth engine.

How the portfolio narrative tends to frame trabectedin

• Investors typically evaluate trabectedin alongside broader PharmaMar and Janssen oncology pipeline and platform risk.
• In years when pipeline milestones underperform, trabectedin demand tends to be used to “smooth” revenue, but it rarely generates inflection-level upside because of market size limitations.

What competitive forces shape trabectedin’s market share in soft-tissue sarcoma?

Bottom line: Competitive pressure comes from both cytotoxic sequenced therapies and newer targeted agents that gain position in subsets of STS, shifting treatment decisions away from older chemotherapy anchors.

What are the key competitor buckets?

1. Other chemotherapy backbones
   • Agents used in later-line STS can displace trabectedin depending on toxicity profile, schedule convenience, and prior exposure patterns.
2. Targeted therapies in molecular subsets
   • STS subtypes with actionable pathways can increasingly steer use away from non-targeted cytotoxics.
3. New combination protocols
   • Trials that define standard-of-care can shift adoption quickly if they improve outcomes or simplify clinical workflows.

How do these forces affect pricing?

• Smaller, niche oncology brands face lower leverage in contracting.
• When payer formularies prefer alternative agents or when centers switch to regimens with better reimbursement dynamics, net price and utilization both compress.

When do key exclusivity and patent expirations affect trabectedin’s commercial outlook?

Bottom line: Without a complete, citation-backed patent and Orange Book/exclusivity record in the source set available here, a precise expiration timeline cannot be stated as a hard business schedule.

How strong is trabectedin’s patent estate for generics or biosimilars risk?

Bottom line: Trabectedin is a small-molecule chemotherapy drug. The generic risk profile depends on the patent landscape for composition, formulations, manufacturing processes, and method-of-use claims linked to approved regimens.

A complete, numbered patent estate with dates is required to quantify generic entry risk. That dataset is not included in the material available for this response, so a defensible strength score cannot be produced.

What is the Orange Book status of trabectedin and are there Paragraph IV challenges?

Bottom line: Paragraph IV litigation and Orange Book listings must be validated from FDA’s Orange Book. A precise status statement cannot be issued without those records.

What formulation and administration factors impact trabectedin uptake and switching?

Bottom line: Trabectedin’s commercial performance is influenced by administration workflow, infusion logistics, infusion time and supportive care requirements, and the degree of regimen standardization at sarcoma centers.

What practice factors usually drive switching behavior?

• Clinical protocol fit
  • If trabectedin protocols require specific premedication or monitoring patterns that increase visit time or staffing load, centers can be slower to adopt unless the clinical benefit is decisive.
• Tolerability management
  • Side-effect handling determines retention and long-term utilization within a line-of-therapy.

How does trabectedin’s adoption compare with other sarcoma oncology agents?

Bottom line: Against broader oncology standards, trabectedin typically underperforms blockbusters because its eligible population is narrower and clinical sequencing is more diversified. Adoption tends to be strongest in high-volume sarcoma centers and in settings where prior therapy history aligns with label criteria.

A precise head-to-head market-share comparison requires sales data for each comparator drug by quarter and geography. No such dataset is provided in the materials here.

What FDA pathway, label breadth, and sequencing rules govern trabectedin use?

Bottom line: Trabectedin’s revenue is closely coupled to label-defined sequencing and to how strictly prescribers and payers adhere to those criteria.

Market impact from label breadth

• Narrower indications typically yield:
  • lower penetration,
  • higher payer scrutiny,
  • slower volume ramp,
  • and reduced resilience to competitor launches.

How do litigation and settlements affect trabectedin commercialization?

Bottom line: Litigation affects generic timing and exclusivity stacking. A verified assessment requires a docketed summary of patent cases tied to trabectedin products. That record is not included here.

What generic entry scenarios are most relevant for trabectedin?

Bottom line: For a niche oncology small molecule, the highest-impact generic scenario is an early or broad generic launch that collapses net pricing through tender-based substitution. The business effect depends on whether generics can substitute interchangeably in hospital formularies and whether manufacturing and distribution capabilities constrain supply.

A specific scenario tree cannot be created without the patent and Orange Book record.

How will trabectedin’s revenue likely move over the next 3 to 7 years?

Bottom line: Absent validated patent/exclusivity and current sales baselines, the best defensible projection is directional: trabectedin revenue is likely to remain limited in absolute magnitude and sensitive to (1) competitive regimen shifts in STS and (2) exclusivity and potential generic pressure. In practice, revenue often trends down when incremental growth drivers fail to materialize and when competitive offerings gain share in later lines.

A numeric forecast requires current net sales, historical quarterly trends, and verified exclusivity/patent timelines.

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Key Takeaways

• Trabectedin’s market remains constrained by narrow STS utilization and heterogeneous histology-driven adoption.
• Revenue trajectory is driven more by specialist center uptake and reimbursement contracting than by broad label breadth.
• Competitive displacement in STS later-line therapy has limited upside growth.
• A hard assessment of generic risk and exclusivity timing requires a verified Orange Book and patent timeline, which is not available in the provided material here.

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FAQs

1. What drives trabectedin utilization in real-world soft-tissue sarcoma practice?
   Sequencing against prior therapies, sarcoma center protocol fit, and payer authorization intensity.

2. Does trabectedin face pricing pressure similar to other oncology chemotherapies?
   Yes, particularly where formularies prioritize lower acquisition cost options and where uptake is limited.

3. What is the biggest commercial risk for trabectedin over time?
   Share loss to alternative regimens plus any generic encroachment timing if exclusivity/patents erode.

4. Why does label breadth matter so much for trabectedin revenue?
   Because narrow indications cap eligible populations and raise reimbursement barriers.

5. Is trabectedin likely to be replaced by generics in hospital tenders?
   Replacement depends on exclusivity/patent status and whether formularies allow substitution without regimen-specific constraints.

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References (APA)

1. No source citations were provided in the prompt content, and no FDA Orange Book, patent database entries, or financial filings were supplied for citation.