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Last Updated: January 15, 2021

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GANCICLOVIR - Generic Drug Details

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

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 Pharm, Mylan Labs Ltd, Par Sterile Products, Pharmascience Inc, and West-ward Pharms Int, 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
Suppliers / Packagers:	2
Bulk Api Vendors:	126
Clinical Trials:	134
Patent Applications:	23
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for GANCICLOVIR
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
Peking University People's Hospital	Phase 1/Phase 2
Horizon 2020 - European Commission	Phase 1/Phase 2
MolMed S.p.A.	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

Paragraph IV (Patent) Challenges for GANCICLOVIR

Tradename	Dosage	Ingredient	NDA	Submissiondate
CYTOVENE	CAPSULE;ORAL	ganciclovir	020460

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
Ranbaxy Labs Ltd	GANCICLOVIR	ganciclovir	CAPSULE;ORAL	076457-002	Jun 27, 2003		DISCN	No	No	Start Trial	Start Trial				Start Trial
Bausch And Lomb	ZIRGAN	ganciclovir	GEL;OPHTHALMIC	022211-001	Sep 15, 2009		RX	Yes	Yes	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

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	Start Trial	Start Trial
Bausch And Lomb	VITRASERT	ganciclovir	IMPLANT;IMPLANTATION	020569-001	Mar 4, 1996	Start Trial	Start Trial
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-002	Dec 12, 1997	Start Trial	Start Trial
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-001	Dec 22, 1994	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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