GANCICLOVIR Drug Patent Profile
When do Ganciclovir patents expire, and what generic alternatives are available?
Ganciclovir is a drug marketed by Ranbaxy Labs Ltd, Am Regent, Custopharm Inc, Fresenius Kabi Usa, Hainan Poly, Hikma, Onesource Specialty, Ph Health, and Pharmascience Inc. and is included in nine NDAs.
The generic ingredient in GANCICLOVIR is ganciclovir sodium. There are two 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
A generic version of GANCICLOVIR was approved as ganciclovir sodium by HIKMA on July 16th, 2003.
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Questions you can ask:
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Summary for GANCICLOVIR
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 151 |
| Clinical Trials: | 164 |
| Patent Applications: | 167 |
| Drug Prices: | Drug price information for GANCICLOVIR |
| What excipients (inactive ingredients) are in GANCICLOVIR? | GANCICLOVIR excipients list |
| DailyMed Link: | GANCICLOVIR at DailyMed |
Recent Clinical Trials for GANCICLOVIR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Health Network, Toronto | PHASE4 |
| Peking University People's Hospital | PHASE2 |
| Qianfo Mountain Hospital, Shandong Province | PHASE4 |
Medical Subject Heading (MeSH) Categories for GANCICLOVIR
Anatomical Therapeutic Chemical (ATC) Classes for GANCICLOVIR
US Patents and Regulatory Information for GANCICLOVIR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ranbaxy Labs Ltd | GANCICLOVIR | ganciclovir | CAPSULE;ORAL | 076457-001 | Jun 27, 2003 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hikma | GANCICLOVIR SODIUM | ganciclovir sodium | INJECTABLE;INJECTION | 076222-001 | Jul 16, 2003 | AP | RX | 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 | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for GANCICLOVIR
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Dr. Gerhard Mann, Chem.-Pharm. Fabrik GmbH.. | Vitrasert Implant | ganciclovir | EMEA/H/C/000120The Vitrasert implant is indicated for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) (See 4.4. Special warnings and special precautions for use). | Withdrawn | no | no | no | 1997-03-18 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
