GANCICLOVIR SODIUM Drug Patent Profile
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Which patents cover Ganciclovir Sodium, and when can generic versions of Ganciclovir Sodium launch?
Ganciclovir Sodium is a drug marketed by Am Regent, Custopharm Inc, Endo Operations, Fresenius Kabi Usa, Hikma, Pharmascience Inc, Slate Run Pharma, and Steriscience Speclts. and is included in eight NDAs.
The generic ingredient in GANCICLOVIR SODIUM is ganciclovir sodium. There are twenty-seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ganciclovir Sodium
A generic version of GANCICLOVIR SODIUM was approved as ganciclovir sodium by HIKMA on July 16th, 2003.
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Summary for GANCICLOVIR SODIUM
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 54 |
| Clinical Trials: | 6 |
| Patent Applications: | 57 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Am Regent | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 202624-001 | Sep 18, 2013 | 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 | |||
| Fresenius Kabi Usa | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 090658-001 | Jun 21, 2010 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Steriscience Speclts | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 204560-001 | Nov 17, 2017 | DISCN | 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 | ||||
| Endo Operations | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 204950-001 | Dec 6, 2016 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pharmascience Inc | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 207645-001 | Dec 8, 2017 | AP | RX | No | Yes | ⤷ 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 |
