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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
Westfälische Wilhelms-Universität Münster	Phase 3
Anturec Pharmaceuticals GmbH	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.

Patents protecting YONDELIS

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

When does loss-of-exclusivity occur for YONDELIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Austria

Brazil

Canada

China

Croatia

Cyprus

Denmark

El Salvador

European Patent Office

Germany

Guatemala

Honduras

Hong Kong

Israel

Japan

Jordan

Malaysia

Mexico

New Zealand

Norway

Panama

Peru

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

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

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

Country	Patent Number	Title	Estimated Expiration
China	102018714	Formulations
New Zealand	554761	Formulations comprising ecteinascidin and a disaccharide
European Patent Office	1658848	Compositions contenant d'ecteinascidin et undisaccharide (Formulations comprising ecteinascidin and a disaccharide)
Croatia	P20070374
Israel	182776	COMPOSITIONS CONTAINING ECTEINASCIDIN AND A DISACCHARIDE
Serbia	50510	FORMULACIJE KOJE SADRŽE EKTEINASCIDIN I DISAHARID