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VALCYTE Drug Profile

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Valcyte 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.

This drug has forty-five patent family members in thirty-two countries.

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:1
Applicants:1
NDAs:2
Suppliers / Packagers: see list1
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
TABLET;ORAL021304-001Mar 29, 2001RXYes6,083,953*PED► subscribe ► subscribe
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
FOR SOLUTION;ORAL022257-001Aug 28, 2009RXYes6,083,953*PED► subscribe ► subscribe
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
TABLET;ORAL021304-001Mar 29, 2001RXYes► subscribe► subscribe
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Expired Patents for Tradename: VALCYTE

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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

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
5,840,891 2-(2-amino-1,6-dihydro-6-oxo-purin-9-yl) methoxy-1,3-propanediol derivative► subscribe
5,856,481 2-(2-amino-1,6-dihydro-6-oxo-purin-9-yl)methoxy-1,3-propanediol derivative► 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
Taiwan434242► subscribe
Canada2154721► subscribe
JapanH0841061► 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
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
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
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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