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GANCICLOVIR SODIUM - Generic Drug Details
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.
Summary for GANCICLOVIR SODIUM
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 9 |
NDAs: | 9 |
Drug Master File Entries: | 27 |
Suppliers / Packagers: | 9 |
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 |
Recent Clinical Trials for GANCICLOVIR SODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Khon Kaen University | Phase 2/Phase 3 |
University of California, San Francisco | Phase 2/Phase 3 |
Francis I. Proctor Foundation | Phase 2/Phase 3 |
Recent Litigation for GANCICLOVIR SODIUM
Identify potential future generic entrants
District Court Litigation
Case Name | Date |
---|---|
ROCHE PALO ALTO LLC v. RANBAXY LABORATORIES LIMITED | 2006-04-28 |
Pharmacology for GANCICLOVIR SODIUM
Drug Class | Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor Nucleoside Analog Antiviral |
Mechanism of Action | DNA Polymerase Inhibitors |
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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