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QuintilesIMS
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Federal Trade Commission
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Generated: October 19, 2017

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VALCYTE Drug Profile

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What is the patent landscape for Valcyte, and what generic Valcyte alternatives are available?

Valcyte is a drug marketed by Hoffmann La Roche and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has thirty-five patent family members in thirty countries and four supplementary protection certificates in four countries.

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 Tradename: VALCYTE

US Patents:1
Applicants:1
NDAs:2
Suppliers / Packagers: see list1
Bulk Api Vendors: see list34
Clinical Trials: see list37
Patent Applications: see list128
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:VALCYTE at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
TABLET;ORAL021304-001Mar 29, 2001ABRXYesYes► Subscribe► Subscribe► Subscribe
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
FOR SOLUTION;ORAL022257-001Aug 28, 2009ABRXYesYes► Subscribe► Subscribe► Subscribe
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
FOR SOLUTION;ORAL022257-001Aug 28, 2009ABRXYesYes► Subscribe► SubscribeY ► 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, 2001► Subscribe► Subscribe
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
FOR SOLUTION;ORAL022257-001Aug 28, 2009► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for VALCYTE

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

Non-Orange Book Patents for Tradename: VALCYTE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,889,109Pharmaceutical dosage forms comprising valganciclovir hydrochloride► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: VALCYTE

Country Document Number Estimated Expiration
Japan2010513237► Subscribe
Portugal2101733► Subscribe
Israel198854► Subscribe
Malaysia152540► Subscribe
World Intellectual Property Organization (WIPO)2008071573► Subscribe
Peru15782008► Subscribe
Mexico2009005921► Subscribe
TaiwanI341730► Subscribe
Russian Federation2009126616► Subscribe
Taiwan200840585► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: VALCYTE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0003France► SubscribePRODUCT NAME: VALGANCICLOVIR AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET EN PARTICULIER LE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 27380 20021016; FIRST REGISTRATION: NL - RVG 25 992 20010920
02/028Ireland► SubscribePRODUCT NAME: VALGANCICLOVIR (2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)- METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE) AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; NAT REGISTRATION NO/DATE: 50/150/1 20020913; FIRST REGISTRATION NO/DATE: NL 25992 20010920; PAEDIATRIC INVESTIGATION PLAN: P/0220/2013
00071Netherlands► SubscribePRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
C/GB02/027United Kingdom► SubscribePRODUCT NAME: 2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)-METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE HYDROCHLORIDE (VALGANCICLOVIR HYDROCHLORIDE); REGISTERED: NL RVG 25992 20010920; UK PL 00031/0599 20020425
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Chubb
Cerilliant
Accenture
Julphar
Cantor Fitzgerald
Cipla
Argus Health
Moodys
Colorcon
Citi

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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