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Details for Generic Name: ganciclovir

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Ganciclovir is the generic ingredient in five branded drugs marketed by Roche Palo, Ranbaxy Labs Ltd, Bausch And Lomb, Fresenius Kabi Usa, Luitpold, and Eurohlth Intl Sarl, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for ganciclovir. One supplier is listed for this compound.

Summary for Generic Name: ganciclovir

Drug Master File Entries: see list22
Suppliers / Packaging: see list2
Therapeutic Class:Antivirals

Clinical Trials for: ganciclovir

Topical Administration of 0.15% Ganciclovir Gel for CMV Anterior Uveitis / Endotheliitis
Status: Completed Condition: Cytomegalovirus Anterior Segment Infection; Anterior Uveitis; Endotheliitis

Evaluate the Use of Ganciclovir Gel 0.3% for the Treatment of Conjunctivitis Caused by Adenovirus
Status: Not yet recruiting Condition: Conjunctivitis; Adenovirus.

Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
Status: Terminated Condition: Allogeneic Stem Cell Transplantation

Individualization of Ganciclovir and Valganciclovir Doses Using Bayesian Prediction in Renal Transplant Patients.
Status: Completed Condition: Infection in Solid Organ Transplant Recipients

Ganciclovir 0,15% Ophthalmic Gel in the Treatment of Adenovirus Keratoconjuntivitis
Status: Completed Condition: Conjunctivitis, Viral; Adenoviridae Infections

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb
IMPLANT;IMPLANTATION020569-001Mar 4, 1996DISCNNo<disabled><disabled>
Roche Palo
CAPSULE;ORAL020460-002Dec 12, 1997DISCNNo<disabled><disabled>
Roche Palo
ganciclovir sodium
INJECTABLE;INJECTION019661-001Jun 23, 1989RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: ganciclovir

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo
CAPSULE;ORAL020460-001Dec 22, 19944,355,032<disabled>
Roche Palo
CAPSULE;ORAL020460-002Dec 12, 19974,642,346<disabled>
Roche Palo
CAPSULE;ORAL020460-002Dec 12, 19974,507,305<disabled>
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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.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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