Viewing data from:

ISTODAX

NDA

ROMIDEPSIN | N022393 | BRISTOL-MYERS SQUIBB CO

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Celgene Corporation et al v. Teva Pharmaceuticals USA, Inc. 1:2015cv01143 2 patentsromidepsin	D. Del.	2015-12-10	Terminated 2016-08-08	—
Celgene Corporation et al v. InnoPharma Inc. 1:2014cv01188 2 patentsANDA 206678romidepsin	D. Del.	2014-09-12	Terminated 2015-12-21	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Istodax (2023)

Total Spending

$489K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$3466.32

Spending Trend

$813K(2019)→$434K(2020)→$232K(2021)→$544K(2022)→$489K(2023)

YoY Change:+0.6%

5yr CAGR:+0.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Istodax (2023)

Total Spending

$28.0M

Total Claims

3,218

Beneficiaries

360

ASP Price

—

HCPCS: J9319 — Injection, romidepsin, lyophilized, 0.1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain3 active DMFs1 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

CONCORD BIOTECH LTDROMIDEPSIN

DMF 273992013

TAPI NL BVROMIDEPSIN

DMF 274002013

MSN LABORATORIES PRIVATE LTDROMIDEPSIN

DMF 334972019

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveROMIDEPSIN

DMF 332352018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Aug 2, 2021	SUPPL -17	View Letter (PDF)
Mar 25, 2021	SUPPL -16	View Letter (PDF)
Dec 18, 2018	SUPPL -15	View Letter (PDF)
Aug 1, 2016	SUPPL -14	View Letter (PDF)
Oct 21, 2014	SUPPL -13	View Letter (PDF)
Jun 14, 2013	SUPPL -11	View Letter (PDF)
Oct 3, 2011	SUPPL -6	View Letter (PDF)
Jun 27, 2011	SUPPL -4	View Letter (PDF)
Apr 15, 2011	SUPPL -1	View Letter (PDF)
Nov 13, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/VIAL

RLDAP

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Nov 5, 2009

No patent or exclusivity listings for this strength.