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:	96
Patent Applications:	5,711
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
Alliance for Clinical Trials in Oncology	Phase 2/Phase 3
National Cancer Institute (NCI)	Phase 2/Phase 3
Westfälische Wilhelms-Universität Münster	Phase 3

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/000773 Yondelis 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/000464 Yondelis 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
Germany	602005001833
Australia	2005227421	Formulations
Hong Kong	1091724	Formulations comprising ecteinascidin and a disaccharide
Cyprus	1107773
Russian Federation	2382647	КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ЭКТИНЭСАЙДИН И ДИСАХАРИД (ECTEINASCIDIN AND DISACCHARIDE-CONTAINING COMPOSITIONS)
Japan	2006124393	FORMULATION

TRABECTEDIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Trabectedin

Introduction to Trabectedin

Trabectedin, also known by its brand name Yondelis, is a chemotherapeutic agent derived originally from the sea squirt Ecteinascidia turbinate and now manufactured synthetically. It has been approved for the treatment of advanced or metastatic soft tissue sarcomas, including liposarcoma and leiomyosarcoma[2].

Market Size and Growth

The global trabectedin market is projected to experience significant growth over the coming years. As of 2023, the market size was valued at several million dollars, with a compound annual growth rate (CAGR) expected to drive the market forward until 2031. The forecast period from 2025 to 2031 is anticipated to see substantial expansion, driven by increasing demand for effective treatments for rare cancers like soft tissue sarcomas[1][4].

Key Market Players

The trabectedin market is dominated by several key players, including Johnson and Johnson, Xeon Biopharmaceutical Limited, BrightGene Bio-Medical, Autran, and Suzhou Borui Biology. These companies play a crucial role in the production, distribution, and marketing of trabectedin, influencing the market dynamics through their competitive strategies and innovations[4].

Applications and Segments

Trabectedin is primarily used in the treatment of various types of cancer, including:

• Breast Cancer Treatment: Although not the primary indication, trabectedin has been explored for its potential in breast cancer treatment.
• Prostate Cancer Treatment: Another area where trabectedin is being researched for its efficacy.
• Pediatric Sarcoma Treatment: Trabectedin shows promise in treating sarcomas in pediatric patients.
• Soft Tissue Sarcomas: The primary and most established use of trabectedin is in the treatment of advanced or metastatic soft tissue sarcomas, such as liposarcoma and leiomyosarcoma[4].

The market is segmented by type into injection products and tablet products, with the injection form being the most common due to its administration method[4].

Regional Analysis

The global trabectedin market is analyzed at the regional level, with different regions exhibiting varying growth rates and market shares. The market is expected to be dominated by regions with advanced healthcare systems and higher prevalence of the targeted cancers. North America and Europe are likely to be significant markets due to their robust healthcare infrastructure and higher adoption rates of new cancer therapies[1].

Clinical Efficacy and Outcomes

Trabectedin has demonstrated significant clinical efficacy in treating advanced soft tissue sarcomas. In the phase III ET743-SAR-3007 trial, trabectedin reduced the risk of disease progression by 45% compared to dacarbazine, with a median progression-free survival (PFS) of 4.2 months versus 1.5 months for dacarbazine. The objective response rate (ORR) was 9.9% with trabectedin, compared to 6.9% with dacarbazine[2].

Economic Analysis and Cost Considerations

The economic analysis of trabectedin versus dacarbazine highlights the higher cost of trabectedin. The cost of trabectedin is approximately $10,408.52 per 28-day course, compared to $2,266.67 for dacarbazine. Despite the higher cost, trabectedin offers significant benefits in terms of PFS and clinical outcomes. The incremental cost-effectiveness ratio (ICER) suggests that while trabectedin is more expensive, it provides substantial clinical benefits that may justify the additional cost[3].

Safety and Adverse Effects

Trabectedin is associated with several adverse effects, including nausea, fatigue, neutropenia, increased ALT and AST levels, vomiting, anemia, constipation, and diarrhea. Grade 3 and 4 adverse events, such as increased ALT levels and neutropenia, are more common in the trabectedin arm. The drug carries a warning for risks such as neutropenic sepsis, rhabdomyolysis, hepatotoxicity, extravasation, tissue necrosis, and cardiomyopathy[2].

Market Drivers and Opportunities

• Increasing Incidence of Soft Tissue Sarcomas: The rising incidence of soft tissue sarcomas and the need for effective treatments drive the demand for trabectedin.
• Approval and Regulatory Support: FDA approval and similar regulatory clearances in other regions enhance the market potential of trabectedin.
• Clinical Efficacy: The proven clinical efficacy of trabectedin in reducing disease progression and improving PFS rates is a significant driver.
• Research and Development: Ongoing research into new indications and combination therapies presents opportunities for market expansion[1][2].

Market Restraints and Challenges

• High Cost: The high cost of trabectedin compared to other treatments can be a barrier to adoption.
• Side Effects: The significant adverse effect profile of trabectedin may limit its use in some patients.
• Competition: The presence of other cancer treatments and the potential for new therapies to enter the market can pose competition to trabectedin[2][3].

Financial Trajectory

The financial trajectory of the trabectedin market is expected to be positive, driven by increasing demand and the high cost of the drug. The market is projected to grow from several million dollars in 2023 to a significantly higher value by 2030, with a CAGR that reflects the growing need for effective cancer treatments. The revenue forecast indicates a steady increase over the forecast period, supported by the clinical benefits and regulatory approvals of trabectedin[1][4].

Key Takeaways

• Market Growth: The global trabectedin market is expected to grow significantly from 2023 to 2031.
• Clinical Efficacy: Trabectedin has demonstrated superior PFS and clinical outcomes compared to dacarbazine.
• Cost Considerations: Despite higher costs, trabectedin offers substantial clinical benefits.
• Market Drivers: Increasing incidence of soft tissue sarcomas, FDA approval, and ongoing research drive the market.
• Challenges: High cost, adverse effects, and competition from other treatments are key challenges.

FAQs

Q: What is the primary indication for trabectedin? A: The primary indication for trabectedin is the treatment of advanced or metastatic soft tissue sarcomas, including liposarcoma and leiomyosarcoma.

Q: How does trabectedin compare to dacarbazine in terms of clinical efficacy? A: Trabectedin has shown a statistically significant reduction in the risk of disease progression and improved PFS rates compared to dacarbazine in clinical trials.

Q: What are the common adverse effects associated with trabectedin? A: Common adverse effects include nausea, fatigue, neutropenia, increased ALT and AST levels, vomiting, anemia, constipation, and diarrhea.

Q: What is the cost of trabectedin compared to dacarbazine? A: Trabectedin is significantly more expensive than dacarbazine, with a cost of approximately $10,408.52 per 28-day course compared to $2,266.67 for dacarbazine.

Q: Who are the main players in the trabectedin market? A: The main players include Johnson and Johnson, Xeon Biopharmaceutical Limited, BrightGene Bio-Medical, Autran, and Suzhou Borui Biology.

Cited Sources

1. Cognitivemarketresearch.com: Trabectedin Market Report 2024 (Global Edition)
2. OncLive: FDA Approves Trabectedin in Soft Tissue Sarcomas
3. pCODR: pan-Canadian Oncology Drug Review Final Economic Guidance Report - Trabectedin (Yondelis) for Metastatic Liposarcoma or Leiomyosarcoma
4. Valuates.com: Global Trabectedin Market Research Report 2024