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Last Updated: December 4, 2021

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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, Hainan Poly Pharm, Hikma Pharms, Mylan Labs Ltd, Par Sterile Products, and Pharmascience Inc, 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
Viracta Therapeutics, Inc.Phase 2
National Heart, Lung, and Blood Institute (NHLBI)Phase 3
Assistance Publique - Hôpitaux de ParisN/A

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Medical Subject Heading (MeSH) Categories for ganciclovir
Paragraph IV (Patent) Challenges for GANCICLOVIR
Tradename Dosage Ingredient NDA Submissiondate
CYTOVENE CAPSULE;ORAL ganciclovir 020460

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
Fresenius Kabi Usa GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 090658-001 Jun 21, 2010 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hikma Pharms GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 076222-001 Jul 16, 2003 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Cheplapharm CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Bausch And Lomb VITRASERT ganciclovir IMPLANT;IMPLANTATION 020569-001 Mar 4, 1996 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-002 Dec 12, 1997 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 020460-002 Dec 12, 1997 ⤷  Free Forever Trial ⤷  Free Forever Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-002 Dec 12, 1997 ⤷  Free Forever Trial ⤷  Free Forever Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-001 Dec 22, 1994 ⤷  Free Forever Trial ⤷  Free Forever Trial
Bausch And Lomb VITRASERT ganciclovir IMPLANT;IMPLANTATION 020569-001 Mar 4, 1996 ⤷  Free Forever Trial ⤷  Free Forever Trial
Roche Palo CYTOVENE ganciclovir CAPSULE;ORAL 020460-001 Dec 22, 1994 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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