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Last Updated: March 28, 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
New York Medical CollegePhase 1/Phase 2
Trellis Bioscience LLCPhase 1
University Hospital, LillePhase 2

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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
Bausch And Lomb VITRASERT ganciclovir IMPLANT;IMPLANTATION 020569-001 Mar 4, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ranbaxy Labs Ltd GANCICLOVIR ganciclovir CAPSULE;ORAL 076457-001 Jun 27, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-002 Dec 12, 1997 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb ZIRGAN ganciclovir GEL;OPHTHALMIC 022211-001 Sep 15, 2009 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cheplapharm CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Exela Pharma GANZYK-RTU ganciclovir SOLUTION;INTRAVENOUS 209347-001 Feb 17, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Ranbaxy Labs Ltd GANCICLOVIR ganciclovir CAPSULE;ORAL 076457-002 Jun 27, 2003 DISCN No 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
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
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-001 Dec 22, 1994 ⤷  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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