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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 207953


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NDA 207953 describes YONDELIS, which is a drug marketed by Janssen Prods and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the YONDELIS profile page.

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 207953
Tradename:YONDELIS
Applicant:Janssen Prods
Ingredient:trabectedin
Patents:1
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207953
Generic Entry Date for 207953*:
Constraining patent/regulatory exclusivity:
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.

Pharmacology for NDA: 207953
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 207953
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
YONDELIS trabectedin POWDER;INTRAVENOUS 207953 NDA Janssen Products, LP 59676-610 59676-610-01 20 mL in 1 VIAL, SINGLE-USE (59676-610-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength1MG/VIAL
Approval Date:Oct 23, 2015TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jul 7, 2028Product Flag?Substance Flag?Delist Request?Y

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.