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Last Updated: March 28, 2024

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.

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Summary for GANCICLOVIR
Drug patent expirations by year for GANCICLOVIR
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
Ranbaxy Labs Ltd GANCICLOVIR ganciclovir CAPSULE;ORAL 076457-001 Jun 27, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Sterile Products GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 204950-001 Dec 6, 2016 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Custopharm Inc GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 212001-001 Jun 20, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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
>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/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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