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ROMIDEPSIN

NDA

ROMIDEPSIN | N208574 | TEVA PHARMACEUTICALS USA INC

2 strengths0 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

1 case 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	—

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

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from E. Rust Consulting LLC FDA-2023-P-2874 · 5 docket documents Ellen Rust of E. Rust Consulting LLC filed this citizen petition requesting that the FDA Commissioner determine whether Romidepsin Injection in two strengths (10mg/2mL and 27.5mg/5.5mL), NDA Number N208574 held by Teva Pharmaceuticals USA Inc., was voluntarily withdrawn from the commercial market fo	505(q)	2023-07-12	Granted	E. Rust Consulting LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

86 trials from ClinicalTrials.gov — 1 recruiting, 3 active, 60 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas NCT02223208	Phase 1/2	Active	Fondazione Italiana Linfomi - ETS	89	2014-09 → 2026-02
Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)NCT02393794	Phase 1/2	Active	Priyanka Sharma	51	2015-07-17 → 2026-07
Study of Pembrolizumab (MK-3475) in Combination With Romidepsin NCT03278782	Phase 1/2	Active	M.D. Anderson Cancer Center	39	2017-11-14 → 2027-07-31
Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma NCT03161223	Phase 1/2	Recruiting	University of Virginia	148	2018-05-30 → 2023-02
FR901228 in Treating Patients With Relapsed or Refractory Multiple Myeloma NCT00066638	Phase 2	Completed	National Cancer Institute (NCI)	50	2003-06 → 2011-03
Decitabine and FR901228 in Treating Patients With Relapsed or Refractory Leukemia, Myelodysplastic Syndromes, or Myeloproliferative Disorders NCT00114257	Phase 1	Completed	National Cancer Institute (NCI)	36	2005-05
A Research Study for Patients With Metastatic Renal Cell Carcinoma NCT00106613	Phase 2	Completed	Celgene	30	2003-05-01 → 2004-08-01
FR901228 in Treating Patients With Metastatic Breast Cancer NCT00098397	Phase 2	Completed	National Cancer Institute (NCI)	37	2005-02
Influence of Rifampin on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer NCT01324323	Phase 1	Completed	Celgene	14	2011-04-01 → 2012-03-01
A Japanese Phase 1/2 Study to Assess the Efficacy, Safety and Pharmacokinetics of Romidepsin in Patients With Peripheral T-cell Lymphoma (PTCL)NCT01456039	Phase 1/2	Completed	Celgene	51	2011-12-01 → 2018-12-14

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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

3 letters from Drugs@FDA

Date	Submission	Document
Dec 9, 2021	SUPPL -6	View Letter (PDF)
Mar 17, 2020	ORIG -1	View Letter (PDF)
Mar 17, 2020	ORIG -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Mar 13, 2020

No patent or exclusivity listings for this strength.

#002 — 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Mar 13, 2020