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Ganciclovir - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ganciclovir?

Ganciclovir is the generic ingredient in five branded drugs marketed by Bausch And Lomb, Exela Pharma Scs Llc, Ranbaxy Labs Ltd, Roche Palo, West-ward Pharms Int, Luitpold Pharms Inc, Par Sterile Products, and Fresenius Kabi Usa, and is included in ten NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for ganciclovir. Three suppliers are listed for this compound.

Summary for Generic Name: ganciclovir

Tradenames:5
Patents:1
Applicants:8
NDAs:10
Drug Master File Entries: see list23
Suppliers / Packagers: see list3
Bulk Api Vendors: see list89
Clinical Trials: see list25
Patent Applications: see list6,406
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ganciclovir at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-002Dec 12, 1997DISCNYesNo► Subscribe► Subscribe
Ranbaxy Labs Ltd
GANCICLOVIR
ganciclovir
CAPSULE;ORAL076457-001Jun 27, 2003DISCNNoNo► Subscribe► Subscribe
Exela Pharma Scs Llc
GANCICLOVIR
ganciclovir
SOLUTION;IV (INFUSION)209347-001Feb 17, 2017RXYesYes► Subscribe► Subscribe
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-001Dec 22, 1994DISCNYesNo► Subscribe► Subscribe
West-ward Pharms Int
GANCICLOVIR SODIUM
ganciclovir sodium
INJECTABLE;INJECTION076222-001Jul 16, 2003DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ganciclovir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-001Dec 22, 19944,355,032► Subscribe
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-002Dec 12, 19974,423,050► Subscribe
Bausch And Lomb
VITRASERT
ganciclovir
IMPLANT;IMPLANTATION020569-001Mar 4, 19965,378,475► Subscribe
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-002Dec 12, 19974,642,346► Subscribe
Roche Palo
CYTOVENE
ganciclovir
CAPSULE;ORAL020460-001Dec 22, 19944,423,050► Subscribe
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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 verifification 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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