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, Endo Operations, Fresenius Kabi Usa, Hikma, Pharmascience Inc, Slate Run Pharma, and Steriscience Speclts, 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

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	6
Patent Applications:	124
What excipients (inactive ingredients) are in ganciclovir sodium?	ganciclovir sodium excipients list
DailyMed Link:	ganciclovir sodium at DailyMed

Recent Clinical Trials for ganciclovir sodium

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

Sponsor	Phase
Chulalongkorn University	Phase 2/Phase 3
Francis I. Proctor Foundation	Phase 2/Phase 3
Khon Kaen University	Phase 2/Phase 3

See all ganciclovir sodium clinical trials

Pharmacology for ganciclovir sodium

Drug Class	Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor Nucleoside Analog Antiviral
Mechanism of Action	DNA Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ganciclovir sodium

J05AB	Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AD	Antivirals
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ganciclovir sodium

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Steriscience Speclts	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	204560-001	Nov 17, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	076222-001	Jul 16, 2003	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Slate Run Pharma	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	204204-001	Nov 8, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

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