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VALCYTE Drug Profile

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Which patents cover Valcyte, and what substitute generic drugs are available?

Valcyte is a drug marketed by Hoffmann La Roche and is included in two NDAs.

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 Tradename: VALCYTE

Patents:0
Applicants:1
NDAs:2
Suppliers / Packagers: see list1
Bulk Api Vendors: see list34
Clinical Trials: see list21
Patent Applications: see list120
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:VALCYTE at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
TABLET;ORAL021304-001Mar 29, 2001RXYesYes► Subscribe► Subscribe
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
FOR SOLUTION;ORAL022257-001Aug 28, 2009RXYesYes► Subscribe► Subscribe
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Expired Patents for Tradename: VALCYTE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
TABLET;ORAL021304-001Mar 29, 20016,083,953*PED► Subscribe
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
FOR SOLUTION;ORAL022257-001Aug 28, 20096,083,953*PED► Subscribe
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Paragraph IV activity for: VALCYTE

Drugname Dosage Strength RLD Submissiondate
valganciclovir hydrochlorideFor Oral Solution50 mg/mLValcyte3/21/2011
valganciclovir hydrochlorideTablets450 mgValcyte12/27/2005
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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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