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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Queensland Health
Accenture
Chinese Patent Office
Citi
Novartis
QuintilesIMS
Dow
Cerilliant

Generated: December 14, 2017

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VALCYTE Drug Profile

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When do Valcyte patents expire, and what generic alternatives are available?

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Hoffmann La RocheVALCYTEvalganciclovir hydrochlorideFOR SOLUTION;ORAL022257-001Aug 28, 2009ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Hoffmann La RocheVALCYTEvalganciclovir hydrochlorideFOR SOLUTION;ORAL022257-001Aug 28, 2009ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Hoffmann La RocheVALCYTEvalganciclovir hydrochlorideFOR SOLUTION;ORAL022257-001Aug 28, 2009ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Hoffmann La RocheVALCYTEvalganciclovir hydrochlorideTABLET;ORAL021304-001Mar 29, 2001ABRXYesYes► Subscribe► Subscribe► 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 RocheVALCYTEvalganciclovir hydrochlorideFOR SOLUTION;ORAL022257-001Aug 28, 2009► Subscribe► Subscribe
Hoffmann La RocheVALCYTEvalganciclovir hydrochlorideTABLET;ORAL021304-001Mar 29, 2001► 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

International Patent Family for Tradename: VALCYTE

Country Document Number Estimated Expiration
Cyprus1113468► Subscribe
CroatiaP20121033► Subscribe
Israel198854► Subscribe
Slovenia2101733► Subscribe
Denmark2101733► Subscribe
Russian Federation2440118► Subscribe
Japan2010513237► Subscribe
Taiwan200840585► Subscribe
BrazilPI0720118► Subscribe
Portugal2101733► 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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Serving leading biopharmaceutical companies globally:

US Department of Justice
Medtronic
Covington
Chubb
Johnson and Johnson
Accenture
Moodys
Harvard Business School
Cerilliant
Deloitte

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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