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YONDELIS Drug Profile

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Which patents cover Yondelis, and what generic alternatives are available?

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-two patent family members in thirty-five 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.

Summary for YONDELIS

International Patents:	42
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	22
Clinical Trials:	43
Patent Applications:	10
Drug Prices:	Drug price information for YONDELIS
DailyMed Link:	YONDELIS at DailyMed

Generic Entry Opportunity Date for YONDELIS

Constraining patent/regulatory exclusivity:

PEDIATRIC EXCLUSIVITY

NDA:

207953

Dosage:

POWDER;IV (INFUSION)

^*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.

Pharmacology for YONDELIS

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Synonyms for YONDELIS

(1'R,6R,6aR,7R,13S,14S,16R)-6',8,14-Trihydroxy-7',9-dimethoxy-4,10,23-trimethyl-19-oxo-3',4',6,7,12,13,14,16-octahydrospiro(6,16-(epithiopropanooxymethano)-7,13-imino-6aH-1,3-dioxolo(7,8)isoquino(3,2-b)(3)benzazocine-20,1'(2'

(1R,2R,3R,11S,12S,14R,26R)-5,6',12-trihydroxy-6,7'-dimethoxy-7,21,30-trimethyl-27-oxo-3',4'-dihydro-2'H-17,19,28-trioxa-24-thia-13,30-diazaspiro[heptacyclo[12.9.6.1;{3,11}.0;{2,13}.0;{4,9}.0;{15,23}.0;{16,20}]triacontane-26,1

(6R,6aR,7R,13S,14S,16R,20R)-6',8,14-trihydroxy-7',9-dimethoxy-4,10,23-trimethyl-19-oxo-3',4',6,7,12,13,14,16-octahydro-2'H,6aH-spiro[7,13-epimino-6,16-(epithiopropanooxymethano)[1,3]dioxolo[7,8]isoquinolino[3,2-b][3]benzazoci

114899-77-3

87541-EP2298780A1

87541-EP2305689A1

AC-27767

AC1L33FK

AKOS025401985

AN-5365

C39H43N3O11S

CAS-114899-77-3

CCRIS 8133

CHEBI:84050

CHEMBL450449

CS-1608

D03RTK

DB05109

DSSTox_CID_26880

DSSTox_GSID_46880

DSSTox_RID_81984

DTXSID2046880

Ect 743

Ecteinascidin

ecteinascidin 743

Ecteinascidin 743;ET-743;Ecteinascidin

Ecteinascidin 743|||ET-743|||Yondelis|||NSC-684766

Ecteinascidin-743

ecteinascidine

Ecteinascidine 743

Et 743

ET-743

ET743

GTPL2774

HY-50936

ID0YZQ2TCP

LS-146121

NCGC00181159-01

NCGC00181159-02

NSC 648766

NSC 684766

NSC-684766

PKVRCIRHQMSYJX-AIFWHQITSA-N

SCHEMBL12119916

Spiro(6,16-(epithiopropanoxymethano)-7,13-imino-12H-1,3-dioxolo(7,8)isoquino(3,2,-b)(3)benzazocine-20,1'(2'H)-isoquinolin)-19-one, 3',4',6,6a,7,13,14,16-octahydro-5-(acetyloxy)-6',8,14-trihydroxy-7',9-dimethoxy-4,10,23-trimet

Spiro(6,16-(epithiopropanoxymethano)-7,13-imino-12H-1,3-dioxolo(7,8)isoquino(3,2,-b)(3)benzazocine-20,1'(2'H)-isoquinolin)-19-one, 5-(acetyloxy)-3',4',6,6a,7,13,14,16-octahydro-6',8,14-trihydroxy-7',9-dimethoxy-4,10,23-trimet

Tox21_112762

Tox21_113236

Trabectedin

Trabectedin [INN]

Trabectedin [USAN:INN:BAN]

UNII-ID0YZQ2TCP

X5006

Yondelis (TN)

Z-3121

ZINC150338708

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

International Patents for YONDELIS

Country	Document Number	Estimated Expiration
Panama	8650801
South Korea	101188691
Hong Kong	1091724
Jordan	2464
Cyprus	1107773
Denmark	1658848