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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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#002 — 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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