Question 1

Is there a generic for Trabectedin?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Trabectedin. It is available as 2 brand (NDA) applications.

Question 2

What is the reference-listed drug for Trabectedin?

Accepted Answer

EVDI (NDA 220837, APOTEX) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Trabectedin?

Accepted Answer

The Orange Book lists 3 patents against Trabectedin products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

What dosage forms of Trabectedin are approved?

Accepted Answer

Trabectedin is approved in the following dosage forms: powder, solution.

Product	Applicant	Application	TE	Approved
EVDIRLD	APOTEX	NDA 220837	—	May 01, 2026
YONDELISRLD	JANSSEN PRODS	NDA 207953	—	Oct 23, 2015

Patent	Expires	In	Type
8895557	Jan 07, 2028	in 1 yr 7 mo	Product
8895557*PED	Jul 07, 2028	in 2 yr 1 mo
12303506	Feb 18, 2043	in 16 yr 11 mo	Product

Trabectedin

Brand (NDA) products · powder, solution

Listed patents (3)

Trabectedin — frequently asked questions

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