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Serving leading biopharmaceutical companies globally:

Cerilliant
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Medtronic
Deloitte
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Healthtrust
Covington
Cipla
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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021304

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NDA 021304 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. Ten suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.

Summary for 021304

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 021304

Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 021304

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALCYTE valganciclovir hydrochloride TABLET;ORAL 021304 NDA Genentech, Inc. 0004-0038 0004-0038-86 1 BOTTLE in 1 CARTON (0004-0038-86) > 60 TABLET, FILM COATED in 1 BOTTLE
VALCYTE valganciclovir hydrochloride TABLET;ORAL 021304 NDA Genentech, Inc. 0004-0038 0004-0038-22 1 BOTTLE, PLASTIC in 1 CARTON (0004-0038-22) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 450MG BASE
Approval Date:Mar 29, 2001TE: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

Expired Orange Book Patents for NDA: 021304

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La RocheVALCYTEvalganciclovir hydrochlorideTABLET;ORAL021304-001Mar 29, 2001► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Cipla
Dow
Baxter
US Department of Justice
Cantor Fitzgerald
Farmers Insurance
Covington
AstraZeneca
Julphar
Merck

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