GANCICLOVIR Drug Patent Profile
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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, Hikma, Par Sterile Products, Pharmascience Inc, Slate Run Pharma, and Steriscience. and is included in nine NDAs.
The generic ingredient in GANCICLOVIR 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
A generic version of GANCICLOVIR was approved as ganciclovir sodium by HIKMA on July 16th, 2003.
Summary for GANCICLOVIR
US Patents: | 0 |
Applicants: | 9 |
NDAs: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 151 |
Clinical Trials: | 150 |
Formulation / Manufacturing: | see details |
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 |
---|---|
New York Medical College | Phase 1/Phase 2 |
Trellis Bioscience LLC | Phase 1 |
Assistance Publique - Hôpitaux de Paris | Phase 3 |
Medical Subject Heading (MeSH) Categories for GANCICLOVIR
Anatomical Therapeutic Chemical (ATC) Classes for GANCICLOVIR
US Patents and Regulatory Information for GANCICLOVIR
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/000120 The 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Withdrawn | no | no | no | 1997-03-18 | |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 |