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CYTOVENE

NDA

GANCICLOVIR | N020460 | ROCHE PALO ALTO LLC

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Cytovene (2023)

Total Spending

$283K

Total Claims

1,194

Beneficiaries

245

ASP Price

—

HCPCS: J1570 — Injection, ganciclovir sodium, 500 mg

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

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.

Products (2)

Sort:

#001 — 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 22, 1994

No patent or exclusivity listings for this strength.

#002 — 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 12, 1997