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Valganciclovir hydrochloride - Generic Drug Details

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Valganciclovir hydrochloride is the generic ingredient in two branded drugs marketed by Hoffmann La Roche, Dr Reddys Labs Ltd, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Hetero Labs Ltd V, and Endo Pharms Inc, and is included in seven NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are fourteen drug master file entries for valganciclovir hydrochloride. Nine suppliers are listed for this compound.

Summary for Generic Name: valganciclovir hydrochloride

Tradenames:2
Patents:1
Applicants:6
NDAs:7
Drug Master File Entries: see list14
Suppliers / Packaging: see list9
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: valganciclovir hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd
VALGANCICLOVIR HYDROCHLORIDE
valganciclovir hydrochloride
TABLET;ORAL204750-001Mar 31, 2016RXNo► subscribe► subscribe
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
TABLET;ORAL021304-001Mar 29, 2001RXYes► subscribe► subscribe
Hoffmann La Roche
VALCYTE
valganciclovir hydrochloride
TABLET;ORAL021304-001Mar 29, 2001RXYes6,083,953*PED► subscribe ► subscribe
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Expired Orange Book Patents for Generic Ingredient: valganciclovir hydrochloride

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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Non-Orange Book Patents for Generic Ingredient: valganciclovir hydrochloride

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
5,856,481 2-(2-amino-1,6-dihydro-6-oxo-purin-9-yl)methoxy-1,3-propanediol derivative► subscribe
5,840,891 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 Ingredient: valganciclovir hydrochloride

Country Document Number Estimated Expiration
Singapore32424► subscribe
Greece960300021► subscribe
Peru32296► 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: VALGANCICLOVIR HYDROCHLORIDE

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
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
C028/2002Ireland► subscribeSPC028/2002: 20040929, EXPIRES: 20160919
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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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