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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, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: ganciclovir

Drug Master File Entries: see list21
Suppliers: see list1
Therapeutic Class:Antivirals

Clinical Trials for: ganciclovir

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

Study of Ganciclovir/Valganciclovir for Prevention of Cytomegalovirus Reactivation in Acute Injury of the Lung and Respiratory Failure
Status: Recruiting Condition: Acute Lung Injury; Acute Respiratory Distress Syndrome; Respiratory Failure

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: Recruiting Condition: Infection in Solid Organ Transplant Recipients

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

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Exclusivity Expiration
CAPSULE; ORAL076457Jun 27, 2003RXYes<disabled><disabled>
Roche Palo
ganciclovir sodium
INJECTABLE; INJECTION019661Jun 23, 1989RXYes<disabled><disabled>
ganciclovir sodium
INJECTABLE; INJECTION076222Jul 16, 2003RXNo<disabled><disabled>
Roche Palo
CAPSULE; ORAL020460Dec 22, 1994DISCNNo<disabled><disabled>
Bausch And Lomb
IMPLANT; IMPLANTATION020569Mar 4, 1996RXYes5,378,475<disabled><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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