Viewing data from:

ZYFLO CR

NDA

ZILEUTON | N022052 | CHIESI USA INC

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain7 active DMFs2 inactive

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

MATRIX PHARMACORP PRIVATE LTDZILEUTON USP

DMF 243342011

MSN LABORATORIES PRIVATE LTDZILEUTON USP [ROUTE CODE "ZN"]

DMF 248272011

EMCURE PHARMACEUTICALS LTDZILEUTON USP

DMF 258052012

BIOPHORE INDIA PHARMACEUTICALS PVT LTDZILEUTON

DMF 264462012

ERREGIERRE SPAZILEUTON USP

DMF 269952013

SOLARA ACTIVE PHARMA SCIENCES LTDZILEUTON USP

DMF 315782017

OPTIMUS DRUGS PRIVATE LTDZILEUTON

DMF 351372020

FARMAK ASInactiveZILEUTON

DMF 276792013

FARMAK ASInactiveZILEUTON USP

DMF 321102017

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

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: May 30, 2007

No patent or exclusivity listings for this strength.