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GANCICLOVIR SODIUM - Generic Drug Details

What are the generic drug sources for ganciclovir sodium and what is the scope of ganciclovir sodium freedom to operate?

Ganciclovir sodium is the generic ingredient in three branded drugs marketed by Roche Palo, Fresenius Kabi Usa, Hainan Poly Pharm, Luitpold, Mylan Labs Ltd, Par Sterile Products, Pharmascience Inc, and West-ward Pharms Int, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for ganciclovir sodium. Seven suppliers are listed for this compound.

US Patents:	0
Tradenames:	3
Applicants:	8
NDAs:	8
Drug Master File Entries:	27
Suppliers / Packagers:	7
Bulk Api Vendors:	31
Clinical Trials:	6
Patent Applications:	11
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GANCICLOVIR SODIUM
DailyMed Link:	GANCICLOVIR SODIUM at DailyMed

Drug Class	Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor Nucleoside Analog Antiviral
Mechanism of Action	DNA Polymerase Inhibitors

02L083W284
107910-75-8
6H-Purin-6-one, 1,9-dihydro-2-amino-9-((2-hydroxy-1-(hydroxymethyl)ethoxy)methyl)-, monosodium salt
6H-Purin-6-one, 2-amino-1,9-dihydro-9-((2-hydroxy-1-(hydroxymethyl)ethoxy)methyl)-, monosodium salt
6H-Purin-6-one, 2-amino-1,9-dihydro-9-((2-hydroxy-1-(hydroxymethyl)ethoxy)methyl)-, sodium salt
82410-32-0 (Parent)
84245-13-6
9-((2-Hydroxy-1-(hydroxymethyl)ethoxy)methyl)guanine, monosodium salt
AB0016776
AC1Q1VAA
AKOS015896059
API0024397
BS-1004
C9H12N5NaO4
CHEMBL1200850
Cytovene IV
Cytovene IV (TN)
Cytovene-IV
D04301
FT-0656038
Ganciclovir sodium (unspecified MF)
Ganciclovir sodium (USAN)
Ganciclovir sodium [USAN]
Ganciclovir Sodium Salt
I06-1697
J-002034
JJICLMJFIKGAAU-UHFFFAOYSA-M
K-0587
KS-00002WRY
MolPort-020-313-387
Natclovir
P006
RS 21592 Sodium
RS-21592 sodium
SC-47228
SCHEMBL149822
Sodium 2-amino-1,9-dihydro-9-((2-hydroxy-1-(hydroxymethyl)ethoxy)methyl)-6H-purin-6-one
sodium 2-amino-9-(((1,3-dihydroxypropan-2-yl)oxy)methyl)-9H-purin-6-olate
sodium 2-amino-9-((1,3-dihydroxypropan-2-yloxy)methyl)-9H-purin-6-olate
sodium 2-amino-9-{[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl}-9h-purin-6-olate
UNII-02L083W284

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Par Sterile Products	GANCICLOVIR	ganciclovir sodium	INJECTABLE;INJECTION	204950-001	Dec 6, 2016	AP	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Mylan Labs Ltd	GANCICLOVIR	ganciclovir sodium	INJECTABLE;INJECTION	204560-001	Nov 17, 2017	AP	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Fresenius Kabi Usa	GANCICLOVIR	ganciclovir sodium	INJECTABLE;INJECTION	090658-001	Jun 21, 2010	AP	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Hainan Poly Pharm	GANCICLOVIR	ganciclovir sodium	INJECTABLE;INJECTION	204204-001	Nov 8, 2018	AP	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Pharmascience Inc	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	207645-001	Dec 8, 2017	AP	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	CYTOVENE	ganciclovir sodium	INJECTABLE;INJECTION	019661-001	Jun 23, 1989	➤ Sign Up	➤ Sign Up
Roche Palo	CYTOVENE	ganciclovir sodium	INJECTABLE;INJECTION	019661-001	Jun 23, 1989	➤ Sign Up	➤ Sign Up
Roche Palo	CYTOVENE	ganciclovir sodium	INJECTABLE;INJECTION	019661-001	Jun 23, 1989	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration