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Last Updated: March 19, 2024

GANCICLOVIR SODIUM Drug Patent Profile


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Which patents cover Ganciclovir Sodium, and when can generic versions of Ganciclovir Sodium launch?

Ganciclovir Sodium is a drug marketed by Am Regent, Custopharm Inc, Fresenius Kabi Usa, Hikma, Par Sterile Products, Pharmascience Inc, Slate Run Pharma, and Steriscience. and is included in eight NDAs.

The generic ingredient in GANCICLOVIR SODIUM 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 Sodium

A generic version of GANCICLOVIR SODIUM was approved as ganciclovir sodium by HIKMA on July 16th, 2003.

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Drug patent expirations by year for GANCICLOVIR SODIUM
Recent Clinical Trials for GANCICLOVIR SODIUM

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SponsorPhase
Chulalongkorn UniversityPhase 2/Phase 3
Francis I. Proctor FoundationPhase 2/Phase 3
Khon Kaen UniversityPhase 2/Phase 3

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US Patents and Regulatory Information for GANCICLOVIR SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
Slate Run Pharma GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 204204-001 Nov 8, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 076222-001 Jul 16, 2003 AP RX 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

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