GANCICLOVIR SODIUM - Generic Drug Details
✉ Email this page to a colleague
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 |
Make Better Decisions: Try a trial or see plans & pricing
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
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
