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Last Updated: March 29, 2024

Ganciclovir - Generic Drug Details


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What are the generic drug sources for ganciclovir and what is the scope of patent protection?

Ganciclovir is the generic ingredient in six branded drugs marketed by Roche Palo, Ranbaxy Labs Ltd, Bausch And Lomb, Exela Pharma, Cheplapharm, Am Regent, Custopharm Inc, Fresenius Kabi Usa, Hikma, Par Sterile Products, Pharmascience Inc, Slate Run Pharma, and Steriscience, and is included in fourteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for ganciclovir. Two suppliers are listed for this compound.

Drug Prices for ganciclovir

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Recent Clinical Trials for ganciclovir

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SponsorPhase
New York Medical CollegePhase 1/Phase 2
Trellis Bioscience LLCPhase 1
Assistance Publique - Hôpitaux de ParisPhase 3

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Medical Subject Heading (MeSH) Categories 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
Pharmascience Inc GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 207645-001 Dec 8, 2017 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 090658-001 Jun 21, 2010 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Am Regent GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 202624-001 Sep 18, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-001 Dec 22, 1994 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-001 Dec 22, 1994 ⤷  Try a Trial ⤷  Try a Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-002 Dec 12, 1997 ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb VITRASERT ganciclovir IMPLANT;IMPLANTATION 020569-001 Mar 4, 1996 ⤷  Try a Trial ⤷  Try a Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-002 Dec 12, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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/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

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