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YONDELIS Drug Profile

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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.

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.

US ANDA Litigation and 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 October 23, 2022. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for YONDELIS

International Patents:	44
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	29
Clinical Trials:	45
Patent Applications:	11
Drug Prices:	Drug price information for YONDELIS
DailyMed Link:	YONDELIS at DailyMed

See drug prices for YONDELIS

Generic Entry Opportunity Date for YONDELIS

Constraining patent/regulatory exclusivity:

FDA exclusivity

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
M.D. Anderson Cancer Center	Phase 1
Sarcoma Oncology Research Center, LLC	Phase 2
Janssen Scientific Affairs, LLC	Phase 1

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	NDA	Submissiondate
YONDELIS	POWDER;INTRAVENOUS	trabectedin	207953	2020-04-23

US Patents and Regulatory Information for 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
Janssen Prods	YONDELIS	trabectedin	POWDER;INTRAVENOUS	207953-001	Oct 23, 2015		RX	Yes	Yes
Janssen Prods	YONDELIS	trabectedin	POWDER;INTRAVENOUS	207953-001	Oct 23, 2015		RX	Yes	Yes
Janssen Prods	YONDELIS	trabectedin	POWDER;INTRAVENOUS	207953-001	Oct 23, 2015		RX	Yes	Yes
Janssen Prods	YONDELIS	trabectedin	POWDER;INTRAVENOUS	207953-001	Oct 23, 2015		RX	Yes	Yes
Janssen Prods	YONDELIS	trabectedin	POWDER;INTRAVENOUS	207953-001	Oct 23, 2015		RX	Yes	Yes
Janssen Prods	YONDELIS	trabectedin	POWDER;INTRAVENOUS	207953-001	Oct 23, 2015		RX	Yes	Yes

International Patents for YONDELIS

Country	Patent Number	Estimated Expiration
Panama	8650801
China	1823794
Guatemala	200500314
Argentina	051653
Croatia	P20070374
Hong Kong	1091724
South Africa	200703450