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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. One supplier is 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 7, 2028. This may change due to patent challenges or generic licensing.

There have been three 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
Patent Applications:	2,415
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

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

NDA:

207953

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 YONDELIS

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

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

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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/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 YONDELIS

See the table below for patents covering YONDELIS around the world.

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)

YONDELIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Yondelis

Introduction

Yondelis, a cancer medication containing the active substance trabectedin, has been a significant player in the oncology market, particularly for the treatment of soft-tissue sarcoma and ovarian cancer. Here, we delve into the market dynamics and financial trajectory of Yondelis, highlighting its clinical efficacy, market performance, and financial outcomes.

Clinical Efficacy and Indications

Yondelis is approved for the treatment of unresectable or metastatic liposarcoma and leiomyosarcoma, as well as for ovarian cancer in combination with pegylated liposomal doxorubicin (PLD)[1][3][4].

• Soft-Tissue Sarcoma: In clinical trials, Yondelis demonstrated a significant delay in tumor growth compared to dacarbazine, with a median progression-free survival of 4.2 months versus 1.5 months for dacarbazine[4].
• Ovarian Cancer: When combined with PLD, Yondelis showed improved efficacy over PLD alone, with patients living an average of 7.3 months without disease progression compared to 5.8 months for those receiving PLD alone[1].

Market Performance

The market performance of Yondelis is influenced by several factors, including sales trends, competition, and regulatory environments.

• Sales Trends: Despite pressure on prices, Yondelis has shown stable to slightly increasing sales. In the first nine months of 2022, net revenues from Yondelis were €52.2 million, similar to the €51.9 million in the same period of 2021. However, gross sales increased by 6% due to higher unit sales[2].
• Competition and Price Pressure: The entry of generic versions of Yondelis into the European market has led to significant price pressure, resulting in an 8% decrease in net sales in 2022 compared to the previous year[5].

Financial Trajectory

The financial performance of Yondelis is closely tied to the overall financial health of its manufacturer, PharmaMar Group.

• Revenue Streams: Yondelis generates revenue through direct sales, royalties, and the sale of raw materials to partners. In 2022, net revenues from Yondelis totaled €63.8 million, down from €69.4 million in 2021 due to price pressure from generics[5].
• EBITDA and R&D Expenses: The Group's EBITDA (earnings before interest, taxes, depreciation, and amortization) decreased by 19% in the first nine months of 2022, primarily due to an increase in R&D expenses by €10.8 million[2].
• Cash and Debt Position: As of September 2022, PharmaMar Group had €241 million in cash and cash equivalents, an increase of 13% from the end of 2021, partly due to a milestone payment related to the Zepzelca license[2].

Licensing Agreements and Milestones

Licensing agreements play a crucial role in the financial trajectory of Yondelis.

• Licensing Income: In 2022, non-recurring revenues from licensing agreements, including a €10 million milestone payment for Yondelis under the licensing agreement with Janssen, contributed significantly to the Group's financials[5].
• Partnerships: The sale of raw materials to partners also adds to the revenue stream, with sales increasing by 11.6% to €21.4 million in 2022[5].

Adverse Reactions and Safety Profile

While Yondelis has shown clinical efficacy, it also comes with a notable safety profile.

• Common Adverse Reactions: Patients treated with Yondelis often experience adverse reactions such as anemia, neutropenia, thrombocytopenia, and increased liver enzymes. Fatal adverse reactions, though rare, can include pancytopenia, febrile neutropenia, and multiorgan failure[3].

Market Outlook

The market outlook for Yondelis is influenced by several factors, including competition from generics, ongoing research and development, and regulatory approvals.

• Generic Competition: The entry of generic versions of Yondelis is expected to continue exerting pressure on prices, potentially impacting future revenue.
• Research and Development: Continued investment in R&D could lead to new indications or improved formulations, potentially offsetting the impact of generics.
• Regulatory Approvals: Maintaining and expanding regulatory approvals in various markets is crucial for sustaining market presence.

Key Takeaways

• Yondelis has demonstrated clinical efficacy in treating soft-tissue sarcoma and ovarian cancer.
• Despite stable to increasing unit sales, net revenues have been impacted by price pressure from generic competitors.
• Licensing agreements and raw material sales contribute significantly to the financial performance.
• The safety profile of Yondelis includes notable adverse reactions that must be managed.
• The market outlook is challenging due to generic competition but may be mitigated by ongoing R&D and regulatory efforts.

FAQs

Q: What is Yondelis used for? Yondelis is used to treat patients with unresectable or metastatic liposarcoma and leiomyosarcoma, as well as ovarian cancer in combination with pegylated liposomal doxorubicin (PLD)[1][3][4].

Q: How is Yondelis administered? Yondelis is administered as a continuous infusion over 24 hours into a vein for soft-tissue sarcoma, and as a 3-hour infusion every three weeks for ovarian cancer[3][4].

Q: What are the common adverse reactions associated with Yondelis? Common adverse reactions include anemia, neutropenia, thrombocytopenia, and increased liver enzymes. Fatal adverse reactions can include pancytopenia, febrile neutropenia, and multiorgan failure[3].

Q: How has the entry of generic Yondelis affected its sales? The entry of generic Yondelis into the European market has led to significant price pressure, resulting in an 8% decrease in net sales in 2022 compared to the previous year[5].

Q: What role do licensing agreements play in the financial performance of Yondelis? Licensing agreements, including milestone payments, contribute significantly to the financial performance of Yondelis, helping to offset declines in direct sales revenue[5].

Sources

1. European Medicines Agency. Yondelis | European Medicines Agency (EMA).
2. Comisión Nacional del Mercado de Valores. PharmaMar Group reports nine months 2022 financial results.
3. European Medicines Agency. Yondelis, INN-trabectedin - European Medicines Agency.
4. U.S. Food and Drug Administration. Drug Trials Snapshots: YONDELIS.
5. Comisión Nacional del Mercado de Valores. PharmaMar Group reports 2022 annual results.