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Generated: November 21, 2018

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Ganciclovir - Generic Drug Details

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What are the generic drug sources for ganciclovir and what is the scope of ganciclovir patent protection?

Ganciclovir is the generic ingredient in five branded drugs marketed by Roche Palo, Ranbaxy Labs Ltd, Bausch And Lomb, Exela Pharma Scs Llc, Fresenius Kabi Usa, Luitpold, Mylan Labs Ltd, Par Sterile Products, Pharmascience Inc, and West-ward Pharms Int, and is included in twelve NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Medical Subject Heading (MeSH) Categories for ganciclovir
Synonyms for ganciclovir
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)
D04301
FT-0656038
GANCICLOVIR SODIUM
Ganciclovir sodium (unspecified MF)
Ganciclovir sodium (USAN)
Ganciclovir sodium [USAN]
Ganciclovir Sodium Salt
HE004149
I06-1697
J-002034
JJICLMJFIKGAAU-UHFFFAOYSA-M
K-0587
KS-00002WRY
MFCD00873979
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-{[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl}-9h-purin-6-olate
ST51053198
UNII-02L083W284

US Patents and Regulatory Information for ganciclovir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Exela Pharma Scs Llc GANCICLOVIR ganciclovir SOLUTION;INTRAVENOUS 209347-001 Feb 17, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-001 Dec 22, 1994 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Roche Palo CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bausch And Lomb ZIRGAN ganciclovir GEL;OPHTHALMIC 022211-001 Sep 15, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pharmascience Inc GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 207645-001 Dec 8, 2017 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Luitpold GANCICLOVIR ganciclovir sodium INJECTABLE;INJECTION 202624-001 Sep 18, 2013 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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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Expired US Patents for ganciclovir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-001 Dec 22, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-001 Dec 22, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-002 Dec 12, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-002 Dec 12, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-002 Dec 12, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Bausch And Lomb VITRASERT ganciclovir IMPLANT;IMPLANTATION 020569-001 Mar 4, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Harvard Business School
Queensland Health
Chinese Patent Office
Dow
Daiichi Sankyo
Merck
Deloitte
Cipla

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