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Last Updated: November 30, 2021

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 seventeen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.
Summary for 022257
Applicant:Hoffmann La Roche
Ingredient:valganciclovir hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 022257
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 0004-0039-09 1 BOTTLE, GLASS in 1 CARTON (0004-0039-09) > 100 mL in 1 BOTTLE, GLASS
Paragraph IV (Patent) Challenges for 022257
Tradename Dosage Ingredient NDA Submissiondate
VALCYTE FOR SOLUTION;ORAL valganciclovir hydrochloride 022257 2011-03-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength50MG/ML
Approval Date:Aug 28, 2009TE:ABRLD:Yes
Patent:⤷  Free Forever TrialPatent Expiration:Dec 11, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Free Forever TrialPatent Expiration:Dec 11, 2027Product Flag?YSubstance Flag?Delist Request?

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