Details for New Drug Application (NDA): 220837

NDA 220837 describes EVDI, which is a drug marketed by Apotex 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 EVDI profile page.

The generic ingredient in EVDI is trabectedin. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the trabectedin profile page.

Summary for 220837

Tradename:	EVDI
Applicant:	Apotex
Ingredient:	trabectedin
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 220837

Dosage:

SOLUTION;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: 220837

Mechanism of Action

Alkylating Activity

Suppliers and Packaging for NDA: 220837

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EVDI	trabectedin	SOLUTION;INTRAVENOUS	220837	NDA	Apotex Corp.	60505-6423	60505-6423-0	1 VIAL, SINGLE-USE in 1 CARTON (60505-6423-0) / 20 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1MG/20ML (0.05MG/ML)
Approval Date:	May 1, 2026	TE:		RLD:	Yes
Patent:		Patent Expiration:	Feb 18, 2043	Product Flag?	Y	Substance Flag?		Delist Request?

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