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, Fresenius Kabi Usa, Hainan Poly, Hikma, Onesource Specialty, Ph Health, and Pharmascience Inc, and is included in fourteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for ganciclovir

US Patents:	1
Tradenames:	6
Applicants:	13
NDAs:	14
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	164
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ganciclovir

Constraining patent/regulatory exclusivity:

9,486,530

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ganciclovir

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

Sponsor	Phase
University Health Network, Toronto	PHASE4
Peking University People's Hospital	PHASE2
Beijing Chao Yang Hospital	PHASE4

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Exela Pharma	GANZYK-RTU	ganciclovir	SOLUTION;INTRAVENOUS	209347-001	Feb 17, 2017		DISCN	Yes	No	9,486,530		Y
Ranbaxy Labs Ltd	GANCICLOVIR	ganciclovir	CAPSULE;ORAL	076457-001	Jun 27, 2003		DISCN	No	No
Am Regent	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	202624-001	Sep 18, 2013		DISCN	No	No
Onesource Specialty	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	204560-001	Nov 17, 2017		DISCN	No	No
Bausch And Lomb	ZIRGAN	ganciclovir	GEL;OPHTHALMIC	022211-001	Sep 15, 2009		RX	Yes	Yes

Expired US Patents for ganciclovir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-001	Dec 22, 1994	4,642,346
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-002	Dec 12, 1997	4,642,346
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-001	Dec 22, 1994	4,355,032
Bausch And Lomb	VITRASERT	ganciclovir	IMPLANT;IMPLANTATION	020569-001	Mar 4, 1996	5,378,475
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-002	Dec 12, 1997	4,355,032

EU/EMA Drug Approvals for ganciclovir

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/000120The 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