Details for New Drug Application (NDA): 207953
✉ Email this page to a colleague
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 Action | Alkylating 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: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 1MG/VIAL | ||||
Approval Date: | Oct 23, 2015 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 7, 2028 | Product Flag? | Substance Flag? | Delist Request? | Y |
Complete Access Available with Subscription