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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 is one patent 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 fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.

Summary for NDA: 022257

Tradename:
VALCYTE
Applicant:
Hoffmann La Roche
Ingredient:
valganciclovir hydrochloride
Patents:1
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 0004-0039-09 1 BOTTLE, GLASS in 1 CARTON (0004-0039-09) > 100 mL in 1 BOTTLE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength50MG/ML
Approval Date:Aug 28, 2009TE:ABRLD:Yes
Patent:6,083,953*PEDPatent Expiration:Sep 29, 2015Product Flag?Substance Flag?Delist Request?
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: 022257

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
FOR SOLUTION;ORAL022257-001Aug 28, 20096,083,953*PED► subscribe
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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. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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