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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 patent protection?
Ganciclovir sodium
is the generic ingredient in two branded drugs marketed by Cheplapharm, Am Regent, Custopharm Inc, Fresenius Kabi Usa, Hainan Poly Pharm, 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: | 34 |
| Clinical Trials: | 6 |
| Patent Applications: | 11 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | GANCICLOVIR SODIUM at DailyMed |
Recent Clinical Trials for GANCICLOVIR SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Taiwan University | Phase 2/Phase 3 |
| Khon Kaen University | Phase 2/Phase 3 |
| University of California, San Francisco | Phase 2/Phase 3 |
Pharmacology for GANCICLOVIR SODIUM
| Drug Class | Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor Nucleoside Analog Antiviral |
| Mechanism of Action | DNA Polymerase Inhibitors |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hainan Poly Pharm | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 204204-001 | Nov 8, 2018 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Am Regent | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 202624-001 | Sep 18, 2013 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Custopharm Inc | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 212001-001 | Jun 20, 2019 | 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 | |||
| Mylan Labs Ltd | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 204560-001 | Nov 17, 2017 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| West-ward Pharms Int | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 076222-001 | Jul 16, 2003 | DISCN | 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 verification 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.
ISSN: 2162-2639
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