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Last Updated: March 29, 2024

GANCICLOVIR SODIUM - Generic Drug Details


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

Ganciclovir sodium is the generic ingredient in two branded drugs marketed by Cheplapharm, Am Regent, Custopharm Inc, Fresenius Kabi Usa, Hikma, Par Sterile Products, Pharmascience Inc, Slate Run Pharma, and Steriscience, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for ganciclovir sodium. Six suppliers are listed for this compound.

Summary for GANCICLOVIR SODIUM
Recent Clinical Trials for GANCICLOVIR SODIUM

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

SponsorPhase
Huang Pacific FoundationPhase 2/Phase 3
University of California, San FranciscoPhase 2/Phase 3
King Chulalongkorn Memorial HospitalPhase 2/Phase 3

See all GANCICLOVIR SODIUM clinical trials

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
Steriscience GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 204560-001 Nov 17, 2017 DISCN No No ⤷  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
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
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
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
>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 SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cheplapharm CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989 ⤷  Try a Trial ⤷  Try a Trial
Cheplapharm CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989 ⤷  Try a Trial ⤷  Try a Trial
Cheplapharm CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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