Is there a generic for Romidepsin?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Romidepsin, referencing the brand ROMIDEPSIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Romidepsin?

ROMIDEPSIN (NDA 208574, TEVA PHARMS USA INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Romidepsin are approved?

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

FDA Orange Book · active-ingredient family

Romidepsin

Romidepsin is approved as 2 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ROMIDEPSIN · NDA 208574

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · powder, solution

Product	Applicant	Application	TE	Approved
ROMIDEPSINRLD×2	TEVA PHARMS USA INC	NDA 208574	—	Mar 13, 2020
ISTODAXRLD	BRISTOL-MYERS	NDA 022393	AP	Nov 05, 2009

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
ROMIDEPSIN	AMNEAL	ANDA 219099	—	Jun 02, 2026
ROMIDEPSIN	FRESENIUS KABI USA	ANDA 206254	AP	Oct 12, 2021

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Romidepsin — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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