Ganciclovir - Generic Drug Details

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

Ganciclovir is the generic ingredient in six branded drugs marketed by Roche Palo, Ranbaxy Labs Ltd, Bausch And Lomb, Exela Pharma, Cheplapharm, Am Regent, Custopharm Inc, Endo Operations, Fresenius Kabi Usa, Hikma, Pharmascience Inc, Slate Run Pharma, and Steriscience Speclts, and is included in fourteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for ganciclovir

US Patents:	1
Tradenames:	6
Applicants:	13
NDAs:	14
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	152
Patent Applications:	5,861
Drug Prices:	Drug price trends for ganciclovir
What excipients (inactive ingredients) are in ganciclovir?	ganciclovir excipients list
DailyMed Link:	ganciclovir at DailyMed

See drug prices for ganciclovir

Recent Clinical Trials for ganciclovir

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

Sponsor	Phase
Merck Sharp & Dohme LLC	Early Phase 1
Virginia Commonwealth University	Early Phase 1
New York Medical College	Phase 1/Phase 2

See all ganciclovir clinical trials

Pharmacology for ganciclovir

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

Medical Subject Heading (MeSH) Categories for ganciclovir

Antiviral Agents

Anatomical Therapeutic Chemical (ATC) Classes for ganciclovir

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

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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
Endo Operations	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	204950-001	Dec 6, 2016	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ranbaxy Labs Ltd	GANCICLOVIR	ganciclovir	CAPSULE;ORAL	076457-002	Jun 27, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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
Am Regent	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	202624-001	Sep 18, 2013		DISCN	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-001	Dec 22, 1994	⤷ Sign Up	⤷ Sign Up
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-001	Dec 22, 1994	⤷ Sign Up	⤷ Sign Up
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-002	Dec 12, 1997	⤷ Sign Up	⤷ Sign Up
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-002	Dec 12, 1997	⤷ Sign Up	⤷ Sign Up
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-002	Dec 12, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for ganciclovir

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Dr. Gerhard Mann, Chem.-Pharm. Fabrik GmbH..	Vitrasert Implant	ganciclovir	EMEA/H/C/000120 The Vitrasert implant is indicated for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) (See 4.4. Special warnings and special precautions for use).	Withdrawn	no	no	no	1997-03-18
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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