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GANZYK-RTU

NDA

GANCICLOVIR | N209347 | EXELA PHARMA SCIENCES LLC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

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Today

9486530

Sep. 2, 2034

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 Chain3 active DMFs4 inactive

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

EXCELLA GMBH AND CO KGGANCICLOVIR

DMF 155672001

SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO LTDGANCICLOVIR

DMF 289732015

APITORIA PHARMA PRIVATE LTDGANCICLOVIR USP

DMF 314022017

RANBAXY LABORATORIES LTDInactiveGANCICLOVIR

DMF 160432002

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveGANCICLOVIR (INTERMEDIATE DRUG SUBSTANCE)

DMF 190492005

EXCELLA GMBHInactiveGANCICLOVIR ANHYDROUS R

DMF 243372010

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDInactiveGANCICLOVIR USP (NON-STERILE API)

DMF 271332013

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 22, 2017	SUPPL -1	View Letter (PDF)
Feb 21, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG/250ML (2MG/ML)

RLD

1 patent0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Feb 17, 2017

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9486530	Sep 2, 2034	—	—	Yes	—	—