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: 2 brands, 2 generics; first approved Nov 05, 2009; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 2 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

ROMIDEPSINRLD

TEVA PHARMS USA INCNDA 20857420202 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/2ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION	INTRAVENOUS	Discontinued	—
27.5MG/5.5ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION	INTRAVENOUS	Discontinued	—

ISTODAXRLDRS

BRISTOL-MYERSNDA 0223932009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/VIAL	POWDER	INTRAVENOUS	Rx	AP

Abbreviated applications

Generic (ANDA) products (2)

ROMIDEPSINRS

AMNEALANDA 2190992026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
27.5MG/5.5ML (5MG/ML)	SOLUTION	INTRAVENOUS	Rx	—

ROMIDEPSIN

FRESENIUS KABI USAANDA 2062542021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/VIAL	POWDER	INTRAVENOUS	Rx	AP

Orange Book patent file

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.

FDA approval span

Approval history

First approval

Nov 05, 2009

16 yr 11 mo ago

Most recent approval

Jun 02, 2026

1 mo ago

Approvals span 2009–2026 across 4 FDA applications.

Brand (NDA) 250%

Generic (ANDA) 250%

Romidepsin — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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