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Last Updated: December 7, 2019

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GANCICLOVIR SODIUM - Generic Drug Details

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

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

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

Recent Clinical Trials for GANCICLOVIR SODIUM

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SponsorPhase
Khon Kaen UniversityPhase 2/Phase 3
University of California, San FranciscoPhase 2/Phase 3
Francis I. Proctor FoundationPhase 2/Phase 3

See all GANCICLOVIR SODIUM clinical trials

Recent Litigation for GANCICLOVIR SODIUM

Identify potential future generic entrants

District Court Litigation
Case NameDate
ROCHE PALO ALTO LLC v. RANBAXY LABORATORIES LIMITED2006-04-28

See all GANCICLOVIR SODIUM litigation

Synonyms for GANCICLOVIR SODIUM
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

US Patents and Regulatory Information for GANCICLOVIR SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
West-ward Pharms Int GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 076222-001 Jul 16, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Par Sterile Products GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 204950-001 Dec 6, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Cheplapharm CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Luitpold GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 202624-001 Sep 18, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Pharmascience Inc GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 207645-001 Dec 8, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 090658-001 Jun 21, 2010 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 204560-001 Nov 17, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for GANCICLOVIR SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cheplapharm CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989   Start Trial   Start Trial
Cheplapharm CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989   Start Trial   Start Trial
Cheplapharm CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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