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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. Seven 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: | 7 |
| Bulk Api Vendors: | 32 |
| 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 |
|---|---|
| University of California, San Francisco | Phase 2/Phase 3 |
| Francis I. Proctor Foundation | Phase 2/Phase 3 |
| King Chulalongkorn Memorial Hospital | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Par Sterile Products | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 204950-001 | Dec 6, 2016 | AP | RX | No | No | 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 | ||||
| Hainan Poly Pharm | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 204204-001 | Nov 8, 2018 | 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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