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Last Updated: August 6, 2020

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Ganciclovir sodium - Generic Drug Details

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What are the generic sources for ganciclovir sodium and what is the scope of freedom to operate?

Ganciclovir sodium is the generic ingredient in two branded drugs marketed by Cheplapharm, Am Regent, Custopharm Inc, Fresenius Kabi Usa, Hainan Poly Pharm, Mylan Labs Ltd, Par Sterile Products, Pharmascience Inc, and West-ward Pharms Int, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for ganciclovir sodium. Seven suppliers are listed for this compound.

Recent Clinical Trials for ganciclovir sodium

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

SponsorPhase
Khon Kaen UniversityPhase 2/Phase 3
University of California, San FranciscoPhase 2/Phase 3
Francis I. Proctor FoundationPhase 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
Am Regent GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 202624-001 Sep 18, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Pharmascience Inc GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 207645-001 Dec 8, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Custopharm Inc GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 212001-001 Jun 20, 2019 DISCN No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Cheplapharm CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989   Start Trial   Start Trial
Cheplapharm CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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