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, Endo Operations, Fresenius Kabi Usa, Hikma, Pharmascience Inc, Slate Run Pharma, and Steriscience, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for ganciclovir sodium. Six suppliers are listed for this compound.
Summary for GANCICLOVIR SODIUM
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 9 |
NDAs: | 9 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 54 |
Clinical Trials: | 6 |
Patent Applications: | 124 |
What excipients (inactive ingredients) are in GANCICLOVIR SODIUM? | GANCICLOVIR SODIUM excipients list |
DailyMed Link: | GANCICLOVIR SODIUM at DailyMed |
Recent Clinical Trials for GANCICLOVIR SODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Huang Pacific Foundation | Phase 2/Phase 3 |
University of California, San Francisco | Phase 2/Phase 3 |
King Chulalongkorn Memorial Hospital | 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 |
Anatomical Therapeutic Chemical (ATC) Classes for GANCICLOVIR SODIUM
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cheplapharm | CYTOVENE | ganciclovir sodium | INJECTABLE;INJECTION | 019661-001 | Jun 23, 1989 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Fresenius Kabi Usa | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 090658-001 | Jun 21, 2010 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Endo Operations | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 204950-001 | Dec 6, 2016 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Custopharm Inc | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 212001-001 | Jun 20, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Slate Run Pharma | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 204204-001 | Nov 8, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Steriscience | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 204560-001 | Nov 17, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Cheplapharm | CYTOVENE | ganciclovir sodium | INJECTABLE;INJECTION | 019661-001 | Jun 23, 1989 | ⤷ Sign Up | ⤷ Sign Up |
Cheplapharm | CYTOVENE | ganciclovir sodium | INJECTABLE;INJECTION | 019661-001 | Jun 23, 1989 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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