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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022257

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NDA 022257 describes VALCYTE, which is a drug marketed by Hoffmann La Roche and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the VALCYTE profile page.

The generic ingredient in VALCYTE is valganciclovir hydrochloride. There are fifteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
Summary for 022257
Tradename:VALCYTE
Applicant:Hoffmann La Roche
Ingredient:valganciclovir hydrochloride
Patents:2
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 022257
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 022257
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALCYTE valganciclovir hydrochloride FOR SOLUTION;ORAL 022257 NDA Genentech, Inc. 0004-0039 N 0004-0039-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength50MG/ML
Approval Date:Aug 28, 2009TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Apr 23, 2018
Regulatory Exclusivity Use:EXTENDED THE DURATION OF THE DOSING REGIMEN FROM 100 DAYS TO 200 DAYS POST-TRANSPLANTATION FOR THE PREVENTION OF CMV DISEASE IN PEDIATRIC KIDNEY TRANSPLANT
Regulatory Exclusivity Expiration:Apr 23, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:➤ Try a Free TrialPatent Expiration:Dec 11, 2027Product Flag?YSubstance Flag?Delist Request?

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