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Last Updated: August 8, 2020

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GANCICLOVIR SODIUM Drug 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, Hainan Poly Pharm, Mylan Labs Ltd, Par Sterile Products, Pharmascience Inc, and West-ward Pharms Int. 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. Seven suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Ganciclovir Sodium

A generic version of GANCICLOVIR SODIUM was approved as ganciclovir sodium by FRESENIUS KABI USA on June 21st, 2010.

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

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SponsorPhase
National Taiwan UniversityPhase 2/Phase 3
Khon Kaen UniversityPhase 2/Phase 3
University of California, San FranciscoPhase 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
Hainan Poly Pharm GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 204204-001 Nov 8, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 076222-001 Jul 16, 2003 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

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim

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